Status:
COMPLETED
Prevention of Dysrhythmias on the Cardiac Intensive Care Unit - Does Maintenance of High-normal Serum Potassium Levels Matter
Lead Sponsor:
Barts & The London NHS Trust
Collaborating Sponsors:
London School of Hygiene and Tropical Medicine
Aberdeen Royal Infirmary
Conditions:
Arrhythmias, Cardiac
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether a strategy of maintaining serum potassium levels at ≥3.6 mEq/L is non-inferior to a strategy of usual treatment (≥4.5 mEq/L) on the occurrence of new ...
Detailed Description
At least one in three patients is affected by atrial fibrillation after cardiac surgery(AFACS), with most episodes occurring in the first five postoperative days. AF occurrence is associated with incr...
Eligibility Criteria
Inclusion
- Scheduled to have isolated CABG surgery
- Patient in sinus rhythm
Exclusion
- Age less than 18 years
- Previous history of Atrial Fibrillation, Atrial Flutter and/or Atrial Tachyarrhythmia
- Pre-operative high-degree atrioventricular (AV) block (defined as Mobitz type 2 second degree AV block or complete heart block)
- Pre-operative serum \[K+\] greater than 5.5 mEq/L
- Current/previous use of medication for the purposes of cardiac rhythm management
- Dialysis-dependent end-stage renal failure
- Concurrent patient involvement in another clinical trial assessing cardiac rhythm post-operative interventions
- Unable to give informed consent
Key Trial Info
Start Date :
October 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 26 2024
Estimated Enrollment :
1684 Patients enrolled
Trial Details
Trial ID
NCT04053816
Start Date
October 20 2020
End Date
June 26 2024
Last Update
November 5 2024
Active Locations (1)
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1
Barts Health NHS Trust
Sutton, London, United Kingdom, EC1A 7DN