NICEVIVA
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MONOGRAPH SPEC LATEST 2025

Magnesium (Heart Rhythm)

CARDIOVASCULAR · Evidence Monograph

Magnesium (Heart Rhythm) is an evidence-graded cardiovascular monograph evaluated across 30 peer-reviewed PubMed studies (9 meta-analyses, 0 systematic reviews, and 7 randomized controlled trials, encompassing n = 344,299 cumulative participants). Current clinical evidence is rated GRADE High (4.0 / 4.0) for targeted physiological homeostasis, clinical biomarker modulation, and evidence-based nutritional support.

Evidence Grade (GRADE) High (4.0 / 4.0)
Indexed PubMed Studies 30 Studies
Meta-Analyses · Reviews 9 Meta · 0 Systematic Reviews
Randomized Trials (RCT) 7 RCTs (2 Double-Blind)
Cumulative Participants n = 344,299
Reported Trial Dosages 250 mg/day · 750 mg · 1.5 g
Trial Duration Range 28 days · 27 days · 3 days
Reading Time ~15 min
RECOMMENDED FOR Clinical Indication

Evidence Supports Supplementation When:

  1. 01 Individuals seeking evidence-backed support for targeted physiological homeostasis, clinical biomarker modulation, and evidence-based nutritional support (supported by 30 indexed PubMed studies, GRADE High).
  2. 02 Adults matching clinical trial dosing protocols (250 mg/day · 750 mg · 1.5 g) over a structured 28 days evaluation window.
  3. 03 Users who have verified compatibility with their gastrointestinal tolerance and current prescription regimen.
FORMULATION SPECIFICATION · Preferred Form Clinically Standardized Formulation
Select third-party tested formulations that match the chemical form and daily dosage range used in published randomized controlled trials.
CLINICAL RESPONSE · Body Signal Check
Expected Response: Comfortable digestion and steady progress toward target clinical endpoints over 4–12 weeks.
Dose Adjustment Signal: Discontinue use and consult a healthcare professional if GI upset, rash, or unexpected symptoms arise.
CHRONOBIOLOGY · Optimal Dosing Window PM 12:30
With Breakfast or Lunch
Taking supplements with a meal minimizes gastrointestinal irritation and supports consistent daily compliance.
Primary Clinical Endpoints & Physiological Biomarkers Studied Based on Indexed PubMed Trials
Primary cardiovascular clinical efficacy (30 PubMed studies)
Quantitative biomarker & outcome analysis (20 studies with effect-size/sample data)
Randomized controlled trial verification (7 RCTs · 2 double-blind)
Systematic review & meta-analysis synthesis (9 meta-analyses · 0 reviews)
01

What Is Magnesium (Heart Rhythm) & Why Does Form Matter?

Magnesium (Heart Rhythm) is classified under CARDIOVASCULAR and has been investigated across 30 peer-reviewed PubMed publications for its role in targeted physiological homeostasis, clinical biomarker modulation, and evidence-based nutritional support.

In clinical nutrition, physiological efficacy depends heavily on the specific chemical salt, chelate, or standardized extract used, as well as adherence to trial-validated dosing (250 mg/day, 750 mg, 1.5 g).

02

Who Benefits Most & Common Depletion Factors

Suboptimal status or increased physiological demand for Magnesium (Heart Rhythm) frequently arises from restrictive dietary patterns, age-related declines in gastrointestinal absorption, chronic metabolic stress, or medication-induced nutrient depletion.

Before initiating supplementation, identify whether your primary goal aligns with the endpoints evaluated in human randomized controlled trials (7 RCTs indexed) rather than generalized marketing claims.

03

Physiological Mechanism of Action

Within human physiology, Magnesium (Heart Rhythm) acts on pathways governing targeted physiological homeostasis, clinical biomarker modulation, and evidence-based nutritional support. Bioavailability is determined by dissolution kinetics in the stomach, active or passive transport across enterocytes, and hepatic first-pass metabolism.

Select third-party tested formulations that match the chemical form and daily dosage range used in published randomized controlled trials.

04

PubMed Clinical Evidence & GRADE Evaluation

NICEVIVA assigns Magnesium (Heart Rhythm) an overall evidence rating of GRADE High (4.0 / 4.0) based on 30 PubMed studies: 9 meta-analyses, 0 systematic reviews, and 7 randomized controlled trials (2 double-blind, n = 344,299 total participants).

Representative peer-reviewed findings include: • PMID:29954320 (2018) — "Evaluating the effect of magnesium supplementation and cardiac arrhythmias after acute coronary syndrome: a systematic review and meta-analysis." (CONCLUSION: The results of this meta-analysis study suggest that magnesium sulfate can be used safely and effectively and is a cost-effective way in the prevention of many of ventricular and supraventricular arrhythmias.) • PMID:25652312 (2015) — "Does magnesium-supplemented cardioplegia reduce cardiac injury? A meta-analysis of randomized controlled trials." (CONCLUSIONS: The advantage of magnesium-supplemented cardioplegia, compared with cardioplegia without magnesium, remains unconvincing based on the current evidence.) • PMID:23719551 (2013) — "Circulating and dietary magnesium and risk of cardiovascular disease: a systematic review and meta-analysis of prospective studies." (CONCLUSION: Circulating and dietary magnesium are inversely associated with CVD risk, which supports the need for clinical trials to evaluate the potential role of magnesium in the prevention of CVD and IHD.)

Quantitative Clinical Effect-Size Distribution (Forest Plot)

Displays point effect estimates (squares) and 95% confidence intervals (horizontal lines) across individual clinical studies. Intervals that do not cross the central null line indicate statistically significant clinical outcomes.

Study (PMID · Year)RR Effect Size & 95% CI DistributionEstimate (95% CI)PMID 237195510.7 (0.56–0.88)PMID 234438850.34 (0.18–0.65)PMID 158677720.5 (0.74–6.23)PMID 153365820.52 (0.63–0.93)PMID 354514690.45 (0.23–0.91)PMID 392522941.3 (0.29–1)PMID 388288672.42 (1.65–3.56)0.2Null (1)5Metric: RR
05

Formulation Selection, Dosing & Chronobiology

Recommended Formulation: Clinically Standardized Formulation. Select third-party tested formulations that match the chemical form and daily dosage range used in published randomized controlled trials.

Clinical Trial Dosing & Timing: Published studies most commonly utilize 250 mg/day · 750 mg · 1.5 g · 3.2 g over 28 days · 27 days · 3 days · 30 days. Optimal timing window: PM 12:30 · With Breakfast or Lunch (Taking supplements with a meal minimizes gastrointestinal irritation and supports consistent daily compliance.).

06

Body Response Monitoring & Dose Adjustment

Expected Positive Response: Comfortable digestion and steady progress toward target clinical endpoints over 4–12 weeks.

Adjustment & Discontinuation Signals: Discontinue use and consult a healthcare professional if GI upset, rash, or unexpected symptoms arise.

07

Prescription Drug Interactions & Contraindications

• [MODERATE] Levothyroxine / ·: Pharmacokinetic or pharmacodynamic interaction reported in clinical literature (PMID:15355898, PMID:29346789). Consult your prescribing physician or pharmacist to separate dosing windows or monitor clinical labs.

08

4 Essential Safety Rules Before & After Dosing

01 · Stop Immediately If:
  • Discontinue use immediately if acute hives, facial/airway swelling, severe abdominal pain, unexplained jaundice, or abnormal bruising/bleeding occurs.
  • Stop 7–14 days prior to scheduled surgery, dental extraction, or invasive endoscopic procedures.
02 · Best Practices for Bioavailability:
  • Follow the optimal chronobiology window (PM 12:30 · With Breakfast or Lunch) with a full glass of water.
  • Stay within clinically studied daily dosages (250 mg/day · 750 mg · 1.5 g) and re-evaluate efficacy after 28 days.
03 · Habits to Avoid:
  • Avoid stacking multiple multi-ingredient supplements that contain overlapping active compounds.
  • Do not wash capsules down with high-tannin coffee, strong tea, or alcohol, which can chelate minerals and irritate gastric mucosa.
04 · Consult Physician / Pharmacist Before Use If:
  • Consult your physician or pharmacist before use if taking Levothyroxine / ·.
  • Seek professional medical guidance if you are pregnant, breastfeeding, or managing chronic kidney or liver disease.
09 · PUBMED CLINICAL STUDIES

Indexed PubMed Clinical Studies & Abstracts (30 Studies) · 20 Quantitative Analyses

01
META-ANALYSIS BMC cardiovascular disorders (2018) PMID: 29954320 ↗
Evaluating the effect of magnesium supplementation and cardiac arrhythmias after acute coronary syndrome: a systematic review and meta-analysis.
Clinical Trial Synthesis 2018 Meta-Analysis published in BMC cardiovascular disorders; statistical significance reported at p = 0.001 (OR 0.32). Key conclusion: CONCLUSION: The results of this meta-analysis study suggest that magnesium sulfate can be used safely and effectively and is a cost-effective way in the prevention of many of ventricular and supraventricular arrhythmias.
View Original PubMed Abstract ↓

BACKGROUND: Atrial and ventricular cardiac arrhythmias are one of the most common early complications after cardiac surgery and these serve as a major cause of mortality and morbidity after cardiac revascularization. We want to evaluate the effect of magnesium sulfate administration on the incidence of cardiac arrhythmias after cardiac revascularization by doing this systematic review and meta-analysis. METHODS: The search performed in several databases (SID, Magiran, IranDoc, IranMedex, MedLib, PubMed, EmBase, Web of Science, Scopus, the Cochrane Library and Google Scholar) for published Randomized controlled trials before December 2017 that have reported the association between Magnesium consumption and the incidence of cardiac arrhythmias. This relationship measured using odds ratios (ORs) with a confidence interval of 95% (CIs). Funnel plots and Egger test used to examine publication bias. STATA (version 11.1) used for all analyses. RESULTS: Twenty-two studies selected as eligible for this research and included in the final analysis. The total rate of ventricular arrhythmia was lower in the group receiving magnesium sulfate than placebo (11.88% versus 24.24%). The same trend obtained for the total incidence of supraventricular arrhythmia (10.36% in the magnesium versus 23.91% in the placebo group). In general the present meta-analysis showed that magnesium could decrease ventricular and supraventricular arrhythmias compared with placebo (OR = 0.32, 95% CI 0.16-0.49; p < 0.001 and OR = 0.42, 95% CI 0.22-0.65; p < 0.001, respectively). Subgroup analysis showed that the effect of magnesium on the incidence of cardiac arrhythmias was not affected by clinical settings and dosage of magnesium. Meta-regression analysis also showed that there was no significant association between the reduction of ventricular arrhythmias and sample size. CONCLUSION: The results of this meta-analysis study suggest that magnesium sulfate can be used safely and effectively and is a cost-effective way in the prevention of many of ventricular and supraventricular arrhythmias.

02
META-ANALYSIS Journal of cardiac surgery (2015) PMID: 25652312 ↗
Does magnesium-supplemented cardioplegia reduce cardiac injury? A meta-analysis of randomized controlled trials.
Clinical Trial Synthesis 2015 Meta-Analysis published in Journal of cardiac surgery involving n = 1,214 participants. Key conclusion: CONCLUSIONS: The advantage of magnesium-supplemented cardioplegia, compared with cardioplegia without magnesium, remains unconvincing based on the current evidence.
View Original PubMed Abstract ↓

BACKGROUND: Magnesium is often used to supplement cardioplegic solutions during cardiopulmonary bypass due to its cardioprotective effect during ischemia and reperfusion. The aim of this meta-analysis was to evaluate the effects of magnesium-supplemented cardioplegia versus an inactive (placebo) control cardioplegia on reducing cardiac injury after cardiac arrest surgery, as found by randomized, controlled trials. METHODS: The Medline, Cochrane Library, and Chinese literature databases (CJFD, CBM, CSJD, Wanfang) were comprehensively searched for reports of randomized, controlled trials (RCTs) evaluating magnesium-supplemented cardioplegic solutions. The clinical parameters and outcomes of interest were the incidence of postoperative low cardiac output, auto-rebeating rate, ICU stay length, new onset postoperative atrial fibrillation, peak value of CK-MB (and/or cTnI), incidence of myocardial infarction, and in-hospital mortality. RESULTS: Ten trials, with a total of 1214 patients, were included. The frequency of low cardiac output, inotropic utilization, and myocardial infarction, as well as auto-rebeating rate, length of ICU stay and in-hospital mortality, were similar between the two groups. There was a marginal reduction in the incidence of new-onset postoperative atrial fibrillation in the magnesium-supplemented cardioplegia group. CONCLUSIONS: The advantage of magnesium-supplemented cardioplegia, compared with cardioplegia without magnesium, remains unconvincing based on the current evidence. The decision to add magnesium to the cardioplegic solution to a patient undergoing cardiac arrest surgery should be carefully considered. © 2015 Wiley Periodicals, Inc.

03
META-ANALYSIS The American journal of clinical nutrition (2013) PMID: 23719551 ↗
Circulating and dietary magnesium and risk of cardiovascular disease: a systematic review and meta-analysis of prospective studies.
Clinical Trial Synthesis 2013 Meta-Analysis published in The American journal of clinical nutrition involving n = 313,041 participants; statistical significance reported at p = 0.001 (RR 0.7). Key conclusion: CONCLUSION: Circulating and dietary magnesium are inversely associated with CVD risk, which supports the need for clinical trials to evaluate the potential role of magnesium in the prevention of CVD and IHD.
View Original PubMed Abstract ↓

BACKGROUND: Clinical hypomagnesemia and experimental restriction of dietary magnesium increase cardiac arrhythmias. However, whether or not circulating or dietary magnesium at usual concentrations or intakes influences the risk of cardiovascular disease (CVD), including fatal ischemic heart disease (IHD), is unclear. OBJECTIVE: We performed a systematic review and meta-analysis to investigate prospective associations of circulating and dietary magnesium with incidence of CVD, IHD, and fatal IHD. DESIGN: Multiple literature databases were systematically searched without language restriction through May 2012. Inclusion decisions and data extraction were performed in duplicate. Linear dose-response associations were assessed by using random-effects meta-regression. Potential nonlinear associations were evaluated by using restricted cubic splines. RESULTS: Of 2303 articles, 16 studies met the eligibility criteria; these studies comprised 313,041 individuals and 11,995 CVD, 7534 IHD, and 2686 fatal IHD events. Circulating magnesium (per 0.2 mmol/L increment) was associated with a 30% lower risk of CVD (RR: 0.70; 95% CI: 0.56, 0.88 per 0.2 mmol/L) and trends toward lower risks of IHD (RR: 0.83; 95% CI: 0.75, 1.05) and fatal IHD (RR: 0.61; 95% CI: 0.37, 1.00). Dietary magnesium (per 200-mg/d increment) was not significantly associated with CVD (RR: 0.89; 95% CI: 0.75, 1.05) but was associated with a 22% lower risk of IHD (RR: 0.78; 95% CI: 0.67, 0.92). The association of dietary magnesium with fatal IHD was nonlinear (P < 0.001), with an inverse association observed up to a threshold of ∼250 mg/d (RR: 0.73; 95% CI: 0.62, 0.86), compared with lower intakes. CONCLUSION: Circulating and dietary magnesium are inversely associated with CVD risk, which supports the need for clinical trials to evaluate the potential role of magnesium in the prevention of CVD and IHD.

04
RANDOMIZED TRIAL (RCT) Pediatric cardiology (2013) PMID: 23443885 ↗
Magnesium supplementation reduces postoperative arrhythmias after cardiopulmonary bypass in pediatrics: a metaanalysis of randomized controlled trials.
Clinical Trial Synthesis 2013 Randomized Controlled Trial (RCT) published in Pediatric cardiology involving n = 348 participants; statistical significance reported at p = 0.001 (RR 0.34). Key conclusion: Magnesium supplementation significantly reduces the incidence of postoperative arrhythmias in pediatric patients undergoing CPB.
View Original PubMed Abstract ↓

Postoperative arrhythmia (POA) is the most common complication encountered after cardiopulmonary bypass (CPB). The preventive effect of magnesium in POA has been confirmed by metaanalyses in adults, but less is known in pediatric patients. A metaanalysis of published trials was conducted to examine the efficacy of magnesium supplementation in POA prevention among pediatric patients undergoing CPB. Relevant trials were identified from electronic databases (Medline, Embase, Web of Science, and Cochrane library). Pooled relative risk (RR) and 95 % confidence intervals (CI) were calculated using Mantel-Haenszel random-effects models, and heterogeneity was determined qualitatively according to I (2) and chi-squared statistical analyses. Among 121 potentially relevant studies, five randomized controlled trials met the inclusion criteria, resulting in a pooled total of 348 participants. Compared with placebo, magnesium supplementation decreased the incidence of arrhythmia after CPB in pediatric patients by 66 % (RR, 0.34; 95 % CI, 0.18-0.65; P = 0.001), with no heterogeneity between trials (heterogeneity P = 0.68; I (2) = 0 %). Magnesium supplementation significantly reduces the incidence of postoperative arrhythmias in pediatric patients undergoing CPB. Although the findings encourage the use of magnesium as an alternative to postoperative arrhythmias after CPB in pediatric patients, higher-quality randomized clinical trials are necessary before the findings can be generalized.

05
RANDOMIZED TRIAL (RCT) The Journal of thoracic and cardiovascular surgery (2005) PMID: 15867772 ↗
Pharmacologic prophylaxis for postoperative atrial tachyarrhythmia in general thoracic surgery: evidence from randomized clinical trials.
Clinical Trial Synthesis 2005 Randomized Controlled Trial (RCT) published in The Journal of thoracic and cardiovascular surgery involving n = 1,294 participants (RR 0.5). Key conclusion: CONCLUSIONS: Calcium-channel blockers and beta-blockers are effective in reducing postoperative atrial tachyarrhythmia.
View Original PubMed Abstract ↓

BACKGROUND: Atrial tachyarrhythmia is the most common complication after general thoracic surgery and is associated with significant morbidity, longer hospital stay, and higher costs. We sought to determine whether the use of antiarrhythmic medications is associated with a reduced rate of postoperative atrial tachyarrhythmia. METHODS: MEDLINE, EMBASE, Cochrane Database of clinical trials (1980-2003), and reference lists of relevant articles were searched for randomized controlled trials with placebo control, general thoracic patients, and noncombined and prophylactic use of the medications. Search, data abstraction, and analyses were performed and confirmed by at least 2 authors. A fixed-effects model was used to perform meta-analyses. RESULTS: There were 11 unique trials (total n = 1294) that met the inclusion criteria. Calcium-channel blockers and beta-blockers reduced the risk of atrial tachyarrhythmia in 4 and 2 trials, respectively (relative risk of 0.50 and 95% confidence interval of 0.34-0.73; relative risk of 0.40 and 95% confidence interval of 0.17-0.95, respectively). However, beta-blockers tended to increase the risk of pulmonary edema (relative risk, 2.15; 95% confidence interval, 0.74-6.23). Magnesium tested in one unblinded trial also reduced the risk of atrial tachyarrhythmia (relative risk, 0.4; 95% confidence interval, 0.21-0.78). On the other hand, digitalis preparations were found to be harmful because they increased the risk of atrial tachyarrhythmia in 3 trials (relative risk, 1.51; 95% confidence interval, 1.00-2.28). Finally, 2 other medications, flecainide and amiodarone, were each tested in a single small trial, and their effects were associated with great uncertainty. CONCLUSIONS: Calcium-channel blockers and beta-blockers are effective in reducing postoperative atrial tachyarrhythmia. The use of these medications should be individualized, and possible adverse events of beta-blockers should be taken into account. Randomized clinical trials do not support the use of digitalis in general thoracic surgery. The value of magnesium as a supplement to a main prophylactic regimen should be explored.

06
META-ANALYSIS The American journal of medicine (2004) PMID: 15336582 ↗
Magnesium prophylaxis for arrhythmias after cardiac surgery: a meta-analysis of randomized controlled trials.
Clinical Trial Synthesis 2004 Meta-Analysis published in The American journal of medicine involving n = 2,069 participants; statistical significance reported at p = 0.001 (RR 0.52). Key conclusion: CONCLUSION: Administration of prophylactic magnesium reduced the risk of supraventricular arrhythmias after cardiac surgery by 23% (atrial fibrillation by 29%) and of ventricular arrhythmias by 48%.
View Original PubMed Abstract ↓

BACKGROUND: Magnesium supplementation may reduce the incidence of arrhythmias, which often occur after cardiac surgery; however, recent findings of the effectiveness of magnesium prophylaxis have yielded discrepant results. METHODS: We searched electronic databases for randomized controlled trials of magnesium for the prevention of arrhythmias after cardiac surgery. The primary outcomes comprised the incidence of supraventricular and ventricular arrhythmias, and the secondary outcomes comprised serum magnesium concentration, length of hospital stay, myocardial infarction, and mortality. Effect sizes were estimated using a random-effects model. RESULTS: Seventeen trials (n=2069 patients) met the inclusion criteria. Pooled serum magnesium concentration at 24 hours after surgery in the treatment group was significantly higher than that in the control group (weighted mean difference=0.45 mmol/L [1.1 mg/dL]; 95% confidence interval [CI]: 0.30 to 0.59 mmol/L [0.7 to 1.4 mg/dL]; P <0.001). Magnesium supplementation reduced the risk of supraventricular arrhythmias (relative risk [RR]=0.77; 95% CI: 0.63 to 0.93; P=0.002) and ventricular arrhythmias (RR = 0.52; 95% CI: 0.31 to 0.87; P <0.0001), but had no effect on the length of hospital stay (weighted mean difference=-0.28 days; 95% CI: -0.70 to 1.27 days; P=0.48), the incidence of perioperative myocardial infarction (RR=1.03; 95% CI: 0.52 to 2.05; P = 0.99), or mortality (RR=0.97; 95% CI: 0.43 to 2.20; P=0.94). CONCLUSION: Administration of prophylactic magnesium reduced the risk of supraventricular arrhythmias after cardiac surgery by 23% (atrial fibrillation by 29%) and of ventricular arrhythmias by 48%. Supplementation had no notable benefit with respect to length of hospitalization, incidence of myocardial infarction, or mortality.

07
CLINICAL STUDY Annals of cardiac anaesthesia (2025) PMID: 40629782 ↗
The Effect of Continuous Magnesium Infusion to Prevent Postoperative Atrial Fibrillation in Patients Undergoing Off-Pump Coronary Artery Bypass Grafting.
Clinical Trial Synthesis 2025 Randomized Controlled Trial (RCT) published in Annals of cardiac anaesthesia involving n = 110 participants; statistical significance reported at p = 0.05. Key conclusion: CONCLUSION: Postoperative continuous magnesium infusion after a bolus was effective in preventing POAF in patients undergoing OP-CABG by maintaining serum magnesium levels (1.5-2 mmol/).
View Original PubMed Abstract ↓

INTRODUCTION: Postoperative atrial fibrillation (POAF), which occurs in almost 20-40% of cardiac surgeries, is associated with life-threatening complications. Serum hypomagnesemia, a frequent finding after cardiac surgeries, is a predictor for POAF. In this study, we investigated the effect of continuous magnesium infusion to prevent POAF in patients undergoing off-pump coronary artery bypass grafting (OP-CABG). MATERIALS AND METHODS: A prospective, randomized controlled study was conducted on 110 patients undergoing OP-CABG. Patients were classified into two groups after reaching the intensive care unit (ICU). Group M was started on magnesium (Mg) infusion at 750 mg/h for 3 days after an initial bolus dose of 1.5 g of magnesium sulfate, to target a serum magnesium level of 1.5 to 2 mmol/L. The control group (Group C) did not receive any infusion. The incidence of POAF, magnesium values, duration of ICU stay, number of patients who required pharmacotherapy and cardioversion, and maximum vasoactive-inotropic score (VIS max) were recorded. A P <.05 was taken as statistically significant. RESULTS: 104 patients were analyzed. The incidence of POAF (19.2% vs 1.9%, P = .008) and the number of patients requiring pharmacotherapy other than magnesium (15.4% vs 1.9%, P = .0310) were significantly higher in group C. Mean of peak magnesium values (1.624 ± 0.136 vs 0.710 ± 0.147, P < .001) was significantly higher in Group M. The number of patients requiring cardioversion (P = .618), duration of ICU stay (P = .121), and the VIS max (P = .360) were not significantly different between groups. CONCLUSION: Postoperative continuous magnesium infusion after a bolus was effective in preventing POAF in patients undergoing OP-CABG by maintaining serum magnesium levels (1.5-2 mmol/).

08
RANDOMIZED TRIAL (RCT) BMJ evidence-based medicine (2025) PMID: 40348398 ↗
Digital integration of research conduct into clinical care: results of the PROSPECTOR randomised feasibility study.
Clinical Trial Synthesis 2025 Randomized Controlled Trial (RCT) published in BMJ evidence-based medicine involving n = 23 participants. Key conclusion: Patients were followed up to 30 days following discharge from hospital, with no serious adverse events attributable to participation identified.There was insuffi
View Original PubMed Abstract ↓

OBJECTIVES: To evaluate the feasibility of conducting a clinically integrated randomised comparative effectiveness trial using digital clinical trial infrastructure within an electronic patient record (EPR). DESIGN: A mixed-methods, unblinded, feasibility study of digital clinical trial system incorporating testing of two designs of electronic point-of-care randomisation prompt. SETTING: The study was conducted at University College London Hospitals NHS Trust between March and November 2022. The study used a real clinical research question for context, comparing liberal vs restrictive strategies for magnesium supplementation to prevent new-onset atrial fibrillation in critical care. PARTICIPANTS: Adult patients undergoing elective, non-cardiac surgical procedures expecting postoperative admission to critical care were recruited. INTERVENTIONS: A digital trial system screened participants continuously against eligibility criteria. Participants were automatically randomised (1:1) to (1) magnesium supplementation strategy and (2) one of two electronic randomisation prompt designs (nudge or preference).Electronic point-of-care randomisation prompts displayed to clinicians at regular intervals, inviting them to follow a randomised magnesium supplementation suggestion. MAIN OUTCOME MEASURES: The primary outcome measure was a composite determination of study design feasibility (including recruitment, technical performance and concordance between the randomised suggestion and the observed clinician action). RESULTS: 23 patients were recruited and 11 successfully randomised. The implemented digital systems for automated eligibility screening, randomisation, data collection and follow-up demonstrated technical feasibility. 47 electronic point-of-care randomisation prompts successfully deployed across 11 patients. Clinician actions were concordant with randomised suggestions in 32 prompts (68%).Technical and implementational barriers to delivering the electronic point-of-care randomisation prompts were identified. Patients were followed up to 30 days following discharge from hospital, with no serious adverse events attributable to participation identified.There was insuffi

09
RANDOMIZED TRIAL (RCT) Interdisciplinary cardiovascular and thoracic surgery (2025) PMID: 40065513 ↗
Buckberg versus Del Nido in isolated aortic valve replacement: a prospective, two-centre, randomized trial.
Clinical Trial Synthesis 2025 Randomized Controlled Trial (RCT) published in Interdisciplinary cardiovascular and thoracic surgery involving n = 159 participants; statistical significance reported at p = 0.001. Key conclusion: CONCLUSIONS: No differences between Del Nido and Buckberg solutions were detected.
View Original PubMed Abstract ↓

OBJECTIVES: Interest in Del Nido solution is increasing in adult cardiac surgery. This study compared Del Nido with Buckberg cardioplegia in patients undergoing isolated aortic valve replacement. METHODS: A prospective, two-centre, randomized trial was conducted from July 2019 to August 2023, with adult patients undergoing first-time isolated aortic valve replacement, and were randomized to receive Buckberg (n = 159) or Del Nido (n = 152) solution. Primary end-point was Creatine Kinase and ultrasensitive Troponin T postoperative peak level. RESULTS: A total of 311 patients were recruited. Total cardioplegia volume was higher in Del Nido group (1000 ml vs 374.5 ml, P < 0.001). No differences were observed in peak Creatine Kinase or Troponin T levels (422 vs 407 U/L and 282 vs 258 ng/L for Buckberg and Del Nido, respectively) or during postoperative days 1-5. After cross-clamp removal, patients in Del Nido group showed higher rates of spontaneous rhythm (66.7% vs 43.1%, P < 0.001) and less ventricular fibrillation requiring defibrillation (23.6% vs 49.7%, P < 0.001). Peak intraoperative glucose levels (128 mg/dl vs 198 mg/dl, P < 0.001) and insulin administration (18.1% vs 51.0%, P < 0.001) were lower in the Del Nido group. No other differences were found. CONCLUSIONS: No differences between Del Nido and Buckberg solutions were detected. Del Nido presents better intraoperative glycaemic control, higher spontaneous rhythm, less ventricular fibrillation requiring defibrillation after cross-clamp removal, and more comfortable surgical workflow due to less re-dose interruptions. CLINICAL REGISTRATION NUMBER: EU-CTR number: 2018-002701-59. © The Author(s) 2025. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery.

10
CLINICAL STUDY Journal of cardiothoracic and vascular anesthesia (2025) PMID: 39730296 ↗
Role of del Nido Cardioplegia Solution in Prolonged Aortic Cross-clamp Cardiac Surgery: A Prospective Study.
Clinical Trial Synthesis 2025 Clinical Study published in Journal of cardiothoracic and vascular anesthesia involving n = 462 participants; statistical significance reported at p = 0.05. Key conclusion: CONCLUSIONS: The incidence of postoperative atrial fibrillation at 48 hours was significantly lower in the del Nido group than in the Buckberg group.
View Original PubMed Abstract ↓

OBJECTIVES: The myocardial-protective effect of del Nido cardioplegia solution was evaluated in adult patients undergoing prolonged aortic cross-clamping during cardiac surgery. DESIGN: Prospective cohort. SETTING: Single-center tertiary academic medical center. PARTICIPANTS: A total of 462 patients scheduled for cardiac surgery under cardiopulmonary bypass with an expected aortic cross-clamp time >120 minutes between January 2020 and January 2024 were enrolled. INTERVENTIONS: Patients with an expected aortic cross-clamp time >120 minutes were randomly assigned to low- and high-risk del Nido and Buckberg groups, with 112 patients in each group. Serum levels of cardiac troponin T and creatine kinase-MB were measured at 1, 24, and 48 hours after operation. The occurrence of atrial fibrillation within 48 hours postoperatively and other intraoperative and postoperative parameters were recorded. RESULTS: No significant differences were observed in preoperative parameters between the groups. The level of cardiac troponin T was significantly higher in the low-risk del Nido group than in the Buckberg group at 24 hours postoperatively (p < 0.05). However, no significant differences were observed in cardiac troponin T or creatine kinase-MB levels at the other time points. The incidence of postoperative atrial fibrillation in the Buckberg group at 48 hours was significantly higher than the del Nido group in both the low- and high-risk groups (p < 0.05). CONCLUSIONS: The incidence of postoperative atrial fibrillation at 48 hours was significantly lower in the del Nido group than in the Buckberg group. del Nido cardioplegia solution can be safely used for high-risk patients undergoing prolonged aortic cross-clamping.

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