Prevention of Dysrhythmias on the Cardiac Intensive Care Unit - Does Maintenance of High-normal Serum Potassium Levels Matter

Summary

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.

Conditions

• Arrhythmias, Cardiac

Interventions

DRUG

Potassium

The trial treatment will start when patients are admitted to the intensive care unit after their surgery. The patient will undergo regular blood investigations, as per current practice. The frequency of K+ monitoring while on ICU will be according to clinician / nursing staff preference. Potassium supplementation will be according to local hospital protocols. This can be either via an intravenous infusion or as a tablet. Patients will otherwise be treated as per current hospital protocol.

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine

  collaborator OTHER

• Aberdeen Royal Infirmary

  collaborator OTHER

• Mid and South Essex NHS Foundation Trust

  collaborator OTHER

• Blackpool Victoria Hospital

  collaborator OTHER

• University Hospitals Bristol and Weston NHS Foundation Trust

  collaborator OTHER

• Hull University Teaching Hospitals NHS Trust

  collaborator OTHER_GOV

• Derriford Hospital

  collaborator OTHER

• Deutsches Herzzentrum der Charité

  collaborator UNKNOWN

• Freeman Health System

  collaborator OTHER

• Golden Jubilee National Hospital

  collaborator OTHER_GOV

• Guy's and St Thomas' NHS Foundation Trust

  collaborator OTHER

• Hammersmith Hospitals NHS Trust

  collaborator OTHER

• Oxford University Hospitals NHS Trust

  collaborator OTHER

• King's College Hospital NHS Trust

  collaborator OTHER

• The Leeds Teaching Hospitals NHS Trust

  collaborator OTHER

• Liverpool Heart and Chest Hospital NHS Foundation Trust

  collaborator OTHER

• Sheffield Teaching Hospitals NHS Foundation Trust

  collaborator OTHER

• Nottingham University Hospitals NHS Trust

  collaborator OTHER

• Royal Infirmary of Edinburgh

  collaborator OTHER

• Royal Sussex County Hospital

  collaborator OTHER

• St George's University Hospitals NHS Foundation Trust

  collaborator OTHER

• Universität Münster

  collaborator OTHER

• Wythenshawe Hospital

  collaborator OTHER

• Barts & The London NHS Trust

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-10-20

Primary Completion

2023-11-22

Completion

2024-06-26

Countries

• United Kingdom

Study Locations