Tight K is a pragmatic, multicentre, non-inferiority randomised clinical trial based in the UK. The study will investigate whether a strategy of maintaining potassium levels at ≥3.6 mEq/L is non-inferior to maintaining at ≥4.5 mEq/L on the occurrence of new onset atrial fibrillation after cardiac surgery.
1684 patients who are undergoing isolated CABG surgery will be recruited into the study.
The study is managed by the Clinical Trials Unit at the London School of Hygiene & Tropical Medicine, and funded by the British Heart Foundation.
The sponsor of the study is Barts Health NHS Trust.
All our study documentation can be accessed here if you want to find out more about how to participate in this research.
A list of our publications can be accessed here.
Tight K is the first appropriately powered non-inferiority multicentre randomised trial of a strategy of 'relaxed' potassium supplementation versus a strategy of 'tight' potassium supplementation, which is defined as standard of care. The routine maintenance of serum [K+] ≥4.5 mEq/L is of unproven efficacy, may be unpleasant or hazardous for patients, and is costly. The findings will have important consequences for patients and clinicians, regardless of whether or not potassium supplementation is found to be non-inferior for the prevention of AF after cardiac surgery. A survey of practice patterns in Europe and North America suggests that there is genuine equipoise, with 67% of caregivers practising in Europe reporting that their institution has a protocol for maintaining high-normal serum potassium levels after cardiac surgery. So one in three do not.
The Tight K Trial will set out to test the hypothesis that AF after cardiac surgery will be no more common after CABG surgery when serum potassium levels are maintained ≥3.6 mEq/L as when they are maintained ≥4.5 mEq/L.
Undergoing isolated CABG surgery
Age less than 18 years
On-going infection or sepsis at the time of recruitment
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 or previous use of medication for the purposes of cardiac rhythm management
Dialysis-dependent end-stage renal failure
Concurrent patient involvement in another clinical study assessing cardiac rhythm post-operative interventions
Unable to provide informed consent
If you are a patient interested in taking part in the study, you can contact the research team at your local hospital to discuss this further.