Peri-Operative Magnesium Infusion to Prevent Atrial Fibrillation Evaluated.
NCT05669417 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 265
Last updated 2024-08-28
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
Interventions
- DRUG
-
Magnesium sulfate
Based on serum levels, bolus and or continuous administration is provided as dictated by study protocol.
Sponsors & Collaborators
-
HagaZiekenhuis
lead OTHER
Principal Investigators
-
Jeroen Ludikhuize, MD, PhD · Medical specialist
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-08-01
- Primary Completion
- 2023-07-17
- Completion
- 2023-08-06
Countries
- Netherlands
Study Locations
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