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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.
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.
Afiliación
  • Meerman M; Department of Intensive Care, HagaZiekenhuis, The Hague, The Netherlands.
  • Buijser M; Department of Cardiology, HagaZiekenhuis, The Hague, The Netherlands.
  • van den Berg L; Department of Intensive Care, HagaZiekenhuis, The Hague, The Netherlands.
  • van den Heuvel AM; Department of Cardiology, HagaZiekenhuis, The Hague, The Netherlands.
  • Hoohenkerk G; Department of Cardiothoracic Surgery, HagaZiekenhuis, The Hague, The Netherlands.
  • van Driel V; Department of Cardiology, HagaZiekenhuis, The Hague, The Netherlands.
  • Munsterman L; Department of Cardiac Anaesthesia, HagaZiekenhui, The Hague, The Netherlands.
  • de Vroege R; Department of Perfusion, HagaZiekenhuis, The Hague, The Netherlands.
  • Bailey M; Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia.
  • Bellomo R; Department of Intensive Care, Austin Health, Melbourne, Australia.
  • Ludikhuize J; Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Australia.
Trials ; 25(1): 540, 2024 Aug 15.
Article en En | MEDLINE | ID: mdl-39148128
ABSTRACT

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:

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 11 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:

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 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 Version 3.3, dated 13-01-2023.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Fibrilación Atrial / Procedimientos Quirúrgicos Cardíacos / Sulfato de Magnesio Límite: Female / Humans / Male / Middle aged Idioma: En Revista: Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2024 Tipo del documento: Article País de afiliación: Países Bajos Pais de publicación: Reino Unido
Texto completo
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XML
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Fibrilación Atrial / Procedimientos Quirúrgicos Cardíacos / Sulfato de Magnesio Límite: Female / Humans / Male / Middle aged Idioma: En Revista: Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2024 Tipo del documento: Article País de afiliación: Países Bajos Pais de publicación: Reino Unido