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Maintenance of Serum Potassium Levels ≥3.6 mEq/L Versus ≥4.5 mEq/L After Isolated Elective Coronary Artery Bypass Grafting and the Incidence of New-Onset Atrial Fibrillation: Pilot and Feasibility Study Results.
Campbell, Niall G; Allen, Elizabeth; Montgomery, Hugh; Aron, Jon; Canter, Ruth R; Dodd, Matthew; Sanders, Julie; Sturgess, Joanna; Elbourne, Diana; O'Brien, Ben.
Affiliation
  • Campbell NG; Division of Cardiovascular Sciences, School of Medical Sciences, Manchester Academic Health Science Centre, University of Manchester, Manchester, United Kingdom; Wythenshawe Hospital, Manchester University Foundation NHS Trust, Manchester, United Kingdom. Electronic address: n.campbell@doctors.org.u
  • Allen E; Clinical Trials Unit, London School of Hygiene & Tropical Medicine, London, United Kingdom.
  • Montgomery H; UCL Division of Medicine and Institute for Sport, Exercise, and Health, London, United Kingdom.
  • Aron J; St. George's Hospital, London, United Kingdom.
  • Canter RR; Clinical Trials Unit, London School of Hygiene & Tropical Medicine, London, United Kingdom.
  • Dodd M; Clinical Trials Unit, London School of Hygiene & Tropical Medicine, London, United Kingdom.
  • Sanders J; St. Bartholomew's Hospital, Barts Health NHS Trust, West Smithfield, London, United Kingdom.
  • Sturgess J; Clinical Trials Unit, London School of Hygiene & Tropical Medicine, London, United Kingdom.
  • Elbourne D; Clinical Trials Unit, London School of Hygiene & Tropical Medicine, London, United Kingdom.
  • O'Brien B; St. Bartholomew's Hospital, Barts Health NHS Trust, West Smithfield, London, United Kingdom; German Heart Center, Department of Cardiac Anesthesiology and Intensive Care Medicine, Berlin, Germany; Department of Cardiac Anesthesiology and Intensive Care Medicine, Charité Berlin, Berlin, Germany; Outc
J Cardiothorac Vasc Anesth ; 36(3): 847-854, 2022 03.
Article in En | MEDLINE | ID: mdl-34404592
ABSTRACT

OBJECTIVE:

Serum potassium levels frequently are maintained at high levels (≥4.5 mEq/L) to prevent atrial fibrillation after cardiac surgery (AFACS), with limited evidence. Before undertaking a noninferiority randomized controlled trial to investigate the noninferiority of maintaining levels ≥3.6 mEq/L compared with this strategy, the authors wanted to assess the feasibility, acceptability, and safety of recruiting for such a trial.

DESIGN:

Pilot and feasibility study of full trial protocol.

SETTING:

Two university tertiary-care hospitals.

PARTICIPANTS:

A total of 160 individuals undergoing first-time elective isolated coronary artery bypass grafting.

INTERVENTIONS:

Randomization (11) to protocols aiming to maintain serum potassium at either ≥3.6 mEq/L or ≥4.5 mEq/L after arrival in the postoperative care facility and for 120 hours or until discharge from the hospital or AFACS occurred, whichever happened first. MEASUREMENTS AND MAIN

RESULTS:

Primary

outcomes:

(1) whether it was possible to recruit and randomize 160 patients for six months (estimated 20% of those eligible); (2) maintaining supplementation protocol violation rate ≤10% (defined as potassium supplementation being inappropriately administered or withheld according to treatment allocation after a serum potassium measurement); and (3) retaining 28-day follow-up rates ≥90% after surgery. Between August 2017 and April 2018, 723 patients were screened and 160 (22%) were recruited. Potassium protocol violation rate = 9.8%. Follow-up rate at 28 days = 94.3%. Data on planned outcomes for the full trial also were collected.

CONCLUSIONS:

It is feasible to recruit and randomize patients to a study assessing the impact of maintaining serum potassium concentrations at either ≥3.6 mEq/L or ≥4.5 mEq/L on the incidence of AFACS.
Subject(s)
Key words

Full text: 1 Database: MEDLINE Main subject: Atrial Fibrillation Type of study: Clinical_trials / Diagnostic_studies / Etiology_studies / Guideline / Incidence_studies / Prognostic_studies / Risk_factors_studies Limits: Humans Language: En Year: 2022 Type: Article

Full text: 1 Database: MEDLINE Main subject: Atrial Fibrillation Type of study: Clinical_trials / Diagnostic_studies / Etiology_studies / Guideline / Incidence_studies / Prognostic_studies / Risk_factors_studies Limits: Humans Language: En Year: 2022 Type: Article