drugset / Trial / NCT04053816
Prevention of Dysrhythmias on the Cardiac Intensive Care Unit - Does Maintenance of High-normal Serum Potassium Levels Matter
Phase 3
Completed
1684 enrolled
Barts & The London NHS Trust
Aberdeen Royal Infirmary · collabBlackpool Victoria Hospital · collabDerriford Hospital · collabDeutsches Herzzentrum der Charité · collabFreeman Health System · collabGolden Jubilee National Hospital · collabGuy's and St Thomas' NHS Foundation Trust · collabHammersmith Hospitals NHS Trust · collabHull University Teaching Hospitals NHS Trust · collabKing's College Hospital NHS Trust · collabLiverpool Heart and Chest Hospital NHS Foundation Trust · collabLondon School of Hygiene and Tropical Medicine · collabMid and South Essex NHS Foundation Trust · collabNottingham University Hospitals NHS Trust · collabOxford University Hospitals NHS Trust · collabRoyal Infirmary of Edinburgh · collabRoyal Sussex County Hospital · collabSheffield Teaching Hospitals NHS Foundation Trust · collabSt George's University Hospitals NHS Foundation Trust · collabThe Leeds Teaching Hospitals NHS Trust · collabUniversity Hospitals Bristol and Weston NHS Foundation Trust · collabUniversität Münster · collabWythenshawe Hospital · collab
RandomizedParallel-groupSingle-blindTreatment
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 onset atrial fibrillation after cardiac surgery (AFACS) in patients undergoing isolated coronary artery bypass graft (CABG) surgery.
Timeline
- Start
- 2020-10-20
- Primary completion
- 2023-11-22
- Completion
- 2024-06-26
Outcome
Met primary endpoint
paper For AFACS prophylaxis, supplementation only when serum potassium concentration fell below 3.6 mEq/L was noninferior to the current widespread practice PMID 39215972 ↗
Publications
- Results O'Brien B, Campbell NG, Allen E, Jamal Z, Sturgess J, Sanders J, Opondo C, Roberts N, Aron J, Maccaroni MR, Gould R, Kirmani BH, Gibbison B, Kunst G, Zarbock A, Kleine-Bruggeney M, Stoppe C, Pearce K, Hughes M, Van Dyck L, Evans R, Montgomery HE, Elbourne D; TIGHT K investigators. Potassium Supplementation and Prevention of Atrial Fibrillation After Cardiac Surgery: The TIGHT K Randomized Clinical Trial. JAMA. 2024 Sep 24;332(12):979-988. doi: 10.1001/jama.2024.17888.
- Campbell NG, Allen E, Evans R, Jamal Z, Opondo C, Sanders J, Sturgess J, Montgomery HE, Elbourne D, O'Brien B. Impact of maintaining serum potassium concentration >/= 3.6mEq/L versus >/= 4.5mEq/L for 120 hours after isolated coronary artery bypass graft surgery on incidence of new onset atrial fibrillation: Protocol for a randomized non-inferiority trial. PLoS One. 2024 Mar 13;19(3):e0296525. doi: 10.1371/journal.pone.0296525. eCollection 2024.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Potassium | Small molecule | — | Intravenous |