Peri-Operative Magnesium Infusion to Prevent Atrial Fibrillation Evaluated.

NCT05669417 | Terminated Phase 2 DMC

• 1 other identifier: T-21-118
• Study Type: interventional
• Target: 265
• Locations: 1 country
• Sites: 1

Brief Summary

Post-operative atrial fibrillation (POAF) is commonly observed in patients post cardiac surgery without a previous history of atrial fibrillation (AF) or other arrythmias. It's associated with significant postoperative complications including infection, bleeding reoperation, increased hospital length of stay (LOHS) and mortality. Magnesium has been identified as a potentially interesting compound with easy access and low toxicity. Hypomagnesemia has been observed frequently immediately after cardiac surgery. Both reduction of abnormal atomicity of atrial myocardium and prolongation of the atrial refractory period caused by administration of magnesium may prevent AF. The POMPAE trial will analyse the effectiveness of MgSO4 versus placebo (double blind randomized trial) in the prevention of POAF after cardiac surgery.

Conditions

Atrial Fibrillation New Onset

Keywords

Cardiac surgery

Outcome Measures

Primary Outcomes (1)

• Incidence of new-onset postoperative atrial fibrillation (POAF)

  New-onset POAF over a period of 5 minutes or longer

  First seven postoperative days

Secondary Outcomes (7)

• 28-day postoperative atrial fibrillation (POAF) post-surgery

  28 days post surgery

• Duration of POAF and peak heart rate recorded

  28 days post surgery

• Length of hospital stay

  Total duration of hospital stay

• Length of ICU stay

  Total length of ICU stay after surgery

• Duration of mechanical ventilation

  Total length of mechanical ventilation during ICU stay after surgery

Study Arms (2)

Magnesium Sulfate

ACTIVE COMPARATOR

Magnesium sulfate is the active compound and will be administered to achieve plasma serum level of magnesium between 1.5 and 2.0 mmol/L according to the study protocol.

Drug: Magnesium sulfate

Ringers Lactate

PLACEBO COMPARATOR

Ringers Lactate is the comparator/placebo and will be administered according to the study protocol.

Drug: Magnesium sulfate

Interventions

Magnesium sulfate DRUG

Based on serum levels, bolus and or continuous administration is provided as dictated by study protocol.

Also known as: magnesium

Magnesium Sulfate; Ringers Lactate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective cardiac surgery (valve surgery and/or CABG)
• years and above
• Mentally competent

You may not qualify if:

• History of atrial fibrillation (AF) or atrial flutter.
• Concomitant rhythm associated procedures (MAZE (surgical ablation)/PVI (pulmonary vein isolation)).
• Pre-existing severe renal impairment (eGFR\<30 ml/min).
• Pre-existing 3rd degree heart block without pacemaker presence.

Sponsors & Collaborators

• HagaZiekenhuis: lead

Study Sites (1)

HagaZiekenhuis

The Hague, South Holland, 2545 AA, Netherlands

Location

Related Publications (1)

• Meerman M, Buijser M, van den Berg L, van den Heuvel AM, Hoohenkerk G, van Driel V, Munsterman L, de Vroege R, Bailey M, Bellomo R, Ludikhuize J. 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. Trials. 2024 Aug 15;25(1):540. doi: 10.1186/s13063-024-08368-3.

  PMID: 39148128 DERIVED

MeSH Terms

Interventions

Magnesium Sulfate; Magnesium

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Metals, Alkaline Earth; Elements; Metals, Light; Metals

Study Officials

• Jeroen Ludikhuize, MD, PhD

  Medical specialist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, MSc

Model Details: Double blinded RCT

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: December 30, 2022
• Study Start: August 1, 2022
• Primary Completion: July 17, 2023
• Study Completion: August 6, 2023
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 2023/2024, a study protocol will be prepared as a separate manuscript and submitted for publication in a peer reviewed journal. This will also include the Statistical Analysis Plan.
• Access Criteria: Upon acceptance of the study protocol in a peer reviewed journal, the materials are available online.

Locations

NL (1)