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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.

Author(s)
Meerman, Manon
Buijser, Marit
van den Berg, Lettie
van den Heuvel, Anne-Marthe
Hoohenkerk, Gerard
van Driel, Vincent
Munsterman, Luuk
de Vroege, Roel
Bailey, Michael
Bellomo, Rinaldo
Ludikhuize, Jeroen
Publication Date
2024-08-15
Abstract
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.
Citation
Trials 2024-08-15; 25(1)
ISSN
1745-6215
Jornal Title
Trials
OrcId
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Link
Subject
Cardiac surgery
Magnesium sulphate
Postoperative atrial fibrillation
Randomized clinical trial
Title
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.
Type of document
Journal Article

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