NCT04053816CompletedPhase 3
Prevention of Dysrhythmias on the Cardiac Intensive Care Unit - Does Maintenance of High-normal Serum Potassium Levels Matter
The TIGHT-K STUDY. Prevention of Dysrhythmias on the Cardiac Intensive Care Unit - Does Maintenance of High-normal Serum Potassium Levels Matter
Source: ClinicalTrials.gov · Last updated 5 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1684 (actual)
- First submitted
- 9 Aug 2019
- Start date
- 20 Oct 2020
- Primary completion date
- 22 Nov 2023
- Lead sponsor
- Barts & The London NHS Trust
- Diseases
- Atrial fibrillation
- NCT number
- NCT04053816
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 1684
- From 20 Oct 2020 to the primary completion date, 22 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous history of Atrial Fibrillation, Atrial Flutter and/or Atrial Tachyarrhythmia
- Current/previous use of medication for the purposes of cardiac rhythm management
- Concurrent patient involvement in another clinical trial assessing cardiac rhythm post-operative interventions
Other illness
- Pre-operative high-degree atrioventricular (AV) block (defined as Mobitz type 2 second degree AV block or complete heart block)
- Dialysis-dependent end-stage renal failure
Lab values
- Pre-operative serum \[K+\] greater than 5.5 mEq/L
Age
- Age less than 18 years
Other
- Unable to give informed consent
Who the study is looking for
- Scheduled to have isolated CABG surgery
- Patient in sinus rhythm
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Barts Health NHS Trust Coordinator of this site? Confirm its status | Sutton | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.