Skip to main content
main-content

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Trials 1/2017

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 – study protocol for a randomised feasibility trial for the proposed Tight K randomized non-inferiority trial

Zeitschrift:
Trials > Ausgabe 1/2017
Autoren:
Niall G. Campbell, Elizabeth Allen, Julie Sanders, Rebecca Swinson, Sophie Birch, Joanna Sturgess, Nawaf Al-Subaie, Diana Elbourne, Hugh Montgomery, Ben O’Brien
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​s13063-017-2349-x) contains supplementary material, which is available to authorized users.

Abstract

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.
Zusatzmaterial
Literatur
Über diesen Artikel

Weitere Artikel der Ausgabe 1/2017

Trials 1/2017 Zur Ausgabe