Key result
The Tight K Pilot trial will evaluate the feasibility of recruiting 160 patients and maintaining protocol adherence when comparing relaxed (≥3.6 mEq/L) versus tight (≥4.5 mEq/L) potassium control after CABG.
Why the study?
Does maintaining serum potassium ≥ 3.6 mEq/L compared to ≥ 4.5 mEq/L prevent new-onset atrial fibrillation in patients undergoing isolated elective CABG?
RCT (n=160)
Open-label with blinded outcome assessment
1:1
Yes
Does maintaining serum potassium ≥ 3.6 mEq/L compared to ≥ 4.5 mEq/L prevent new-onset atrial fibrillation in patients undergoing isolated elective CABG?
This protocol outlines a feasibility trial to determine if a relaxed potassium control strategy (≥3.6 mEq/L) can be safely and effectively studied against tight control (≥4.5 mEq/L) for preventing atrial fibrillation after CABG.
Should not yet change practice; leaves open whether relaxed potassium supplementation safely prevents postoperative atrial fibrillation pending definitive.
BACKGROUND: Atrial fibrillation (AF) occurs in approximately one in three patients after cardiac surgery, and is associated with increased short-term and long-term mortality, intensive care unit (ICU) and hospital stay, and increased cost of care. In an attempt to reduce AF incidence in these patients, serum potassium (K+) levels are commonly maintained at the high end of normal (4.5-5.5 mEq/L). However, such potassium supplementation is without proven benefit, and is not without negative consequences. It carries clinical risk, negatively impacts patient experience and is both time-consuming and costly. This protocol describes a randomised controlled pilot trial to assess the feasibility of a proposed randomised non-inferiority trial to investigate the impact of maintaining serum potassium ≥ 3.6 mEq/L vs ≥ 4.5 mEq/L on the incidence of new-onset atrial fibrillation in the first 120 hours after isolated elective coronary artery bypass grafting. METHODS: Design: this is a randomized feasibility trial as a pilot for a randomized non-inferiority trial. PARTICIPANTS: are 160 patients undergoing isolated coronary artery bypass grafting at two centres. Allocation: patients will be randomized (1:1) to protocols aiming to maintain serum potassium at either ≥ 3.6 mEq/L ("relaxed control") or ≥ 4.5 mEq/L ("tight control"). Primary analytic aim: was to assess the feasibility and acceptability of planning and delivering the intervention and trial methods to inform a full-scale non-inferiority trial. OUTCOME: the primary indicative efficacy outcome measures being field-tested are feasibility of participant recruitment and randomization, maintaining a protocol violation rate < 10%, and retaining 90% patient follow up 28 days after surgery. The primary clinical outcome measure of the future full "Tight K Study" will be incidence of AF after cardiac surgery. DISCUSSION: The Tight K Pilot will assess the feasibility of conducting the full trial, which is intended to confirm or refute the efficacy of current potassium management in preventing AF after cardiac surgery. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03195647 . Registered on 23 May 2017. Last updated 19June 2017.
No takes yet. Share an insight, caveat, or question.
Campbell et al. (2017) conducted an RCT in Patients undergoing isolated elective coronary artery bypass grafting (CABG) (n=160). Relaxed potassium control (≥ 3.6 mEq/L) vs. Tight potassium control (≥ 4.5 mEq/L) was evaluated on Feasibility of participant recruitment and randomization, maintaining a protocol violation rate < 10%, and retaining 90% patient follow up 28 days after surgery. The Tight K Pilot trial will evaluate the feasibility of recruiting 160 patients and maintaining protocol adherence when comparing relaxed (≥3.6 mEq/L) versus tight (≥4.5 mEq/L) potassium control after CABG.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: