Magnesium sulphate to prevent perioperative atrial fibrillation in cardiac surgery: a randomized clinical trial : A protocol description of the PeriOperative Magnesium Infusion to Prevent Atrial fibrillation Evaluated (POMPAE) trial.
Humans
Atrial Fibrillation
/ prevention & control
Magnesium Sulfate
/ administration & dosage
Cardiac Surgical Procedures
/ adverse effects
Double-Blind Method
Infusions, Intravenous
Treatment Outcome
Postoperative Complications
/ prevention & control
Clinical Trials, Phase II as Topic
Randomized Controlled Trials as Topic
Perioperative Care
/ methods
Female
Time Factors
Male
Equivalence Trials as Topic
Middle Aged
Cardiac surgery
Magnesium sulphate
Postoperative atrial fibrillation
Randomized clinical trial
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
15 Aug 2024
15 Aug 2024
Historique:
received:
08
01
2024
accepted:
02
08
2024
medline:
16
8
2024
pubmed:
16
8
2024
entrez:
15
8
2024
Statut:
epublish
Résumé
Postoperative atrial fibrillation (POAF) is a common and potentially serious complication post cardiac surgery. Hypomagnesaemia is common after cardiac surgery and recent evidence indicates that supplementation of magnesium may prevent POAF. We aim to investigate the effectiveness of continuous intravenous magnesium sulphate administration in the perioperative period to prevent POAF as compared to placebo. The (POMPAE) trial is a phase 2, single-center, double-blinded randomized superiority clinical study. It aims to assess the impact of perioperative continuous intravenous magnesium administration on the occurrence of cardiac surgery-related POAF. A total of 530 patients will be included. Eligible patients will be randomized in 1:1 ratio to the intervention or placebo group with stratification based on the presence of valvular surgery. The objective of the infusion is to maintain ionized magnesium levels between 1.5 and 2.0 mmol/L. The primary outcome measure is the incidence of de novo POAF within the first 7 days following surgery, with censoring at hospital discharge. This trial may generate crucial evidence for the prevention of POAF and reduce clinical adverse events in patients following cardiac surgery. The POMPAE trial was registered at ClinicalTrials.gov under the following identifier NTC05669417, https://clinicaltrials.gov/ct2/show/NCT05669417 . Registered on December 30, 2022. Version 3.3, dated 13-01-2023.
Sections du résumé
BACKGROUND
BACKGROUND
Postoperative atrial fibrillation (POAF) is a common and potentially serious complication post cardiac surgery. Hypomagnesaemia is common after cardiac surgery and recent evidence indicates that supplementation of magnesium may prevent POAF. We aim to investigate the effectiveness of continuous intravenous magnesium sulphate administration in the perioperative period to prevent POAF as compared to placebo.
METHODS
METHODS
The (POMPAE) trial is a phase 2, single-center, double-blinded randomized superiority clinical study. It aims to assess the impact of perioperative continuous intravenous magnesium administration on the occurrence of cardiac surgery-related POAF. A total of 530 patients will be included. Eligible patients will be randomized in 1:1 ratio to the intervention or placebo group with stratification based on the presence of valvular surgery. The objective of the infusion is to maintain ionized magnesium levels between 1.5 and 2.0 mmol/L.
DISCUSSION
CONCLUSIONS
The primary outcome measure is the incidence of de novo POAF within the first 7 days following surgery, with censoring at hospital discharge. This trial may generate crucial evidence for the prevention of POAF and reduce clinical adverse events in patients following cardiac surgery.
TRIAL REGISTRATION
BACKGROUND
The POMPAE trial was registered at ClinicalTrials.gov under the following identifier NTC05669417, https://clinicaltrials.gov/ct2/show/NCT05669417 . Registered on December 30, 2022.
PROTOCOL VERSION
METHODS
Version 3.3, dated 13-01-2023.
Identifiants
pubmed: 39148128
doi: 10.1186/s13063-024-08368-3
pii: 10.1186/s13063-024-08368-3
doi:
Substances chimiques
Magnesium Sulfate
7487-88-9
Banques de données
ClinicalTrials.gov
['NCT05669417']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
540Informations de copyright
© 2024. The Author(s).
Références
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