NCT04053816

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,684

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2020

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 13, 2019

Completed
1.2 years until next milestone

Study Start

First participant enrolled

October 20, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2024

Completed
Last Updated

November 5, 2024

Status Verified

November 1, 2024

Enrollment Period

3.1 years

First QC Date

August 9, 2019

Last Update Submit

November 4, 2024

Conditions

Arrhythmias, Cardiac

Keywords

cardiovascularpotassium supplementationcardiac surgeryatrial fibrillationcoronary artery bypass graftingpotassium

Outcome Measures

Primary Outcomes (1)

  • The presence of new onset AFACS until until hour 120 after initial admission to ICU/post-operative care facility, or discharge from hospital, whichever occurs first.

    Episode of AFACS lasting ≥30 seconds that is both clinically detected and electrocardiographically confirmed (on either a 12-lead electrocardiogram (ECG), telemetry or Holter monitoring

    Maximum of 5 days

Secondary Outcomes (9)

  • The incidence of new onset AFACS

    Maximum of 5 days

  • The incidence of at least one episode of AFACS

    Maximum of 5 days

  • Number of patients experiencing at least one episode of a non-AF arrhythmia.

    Maximum of 5 days

  • In-patient mortality

    Maximum 6 months

  • 6-month mortality

    Maximum 6 months

  • +4 more secondary outcomes

Study Arms (2)

Relaxed control

EXPERIMENTAL

Those randomised to the 'Relaxed' Group will receive potassium supplementation only if their serum potassium drops below 3.6 mEq/L.

Drug: Potassium

Tight control

ACTIVE COMPARATOR

Patients randomised to the 'Tight' group will receive potassium supplementation if their serum potassium falls below 4.5 mEq/L (current practice).

Drug: Potassium

Interventions

PotassiumDRUG

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.

Relaxed controlTight control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled to have isolated CABG surgery
  • Patient in sinus rhythm

You may not qualify if:

  • Age less than 18 years
  • Previous history of Atrial Fibrillation, Atrial Flutter and/or Atrial Tachyarrhythmia
  • 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/previous use of medication for the purposes of cardiac rhythm management
  • Dialysis-dependent end-stage renal failure
  • Concurrent patient involvement in another clinical trial assessing cardiac rhythm post-operative interventions
  • Unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barts Health NHS Trust

Sutton, London, EC1A 7DN, United Kingdom

Location

Related Publications (2)

  • O'Brien B, Campbell NG, Allen E, Jamal Z, Sturgess J, Sanders J, Opondo C, Roberts N, Aron J, Maccaroni MR, Gould R, Kirmani BH, Gibbison B, Kunst G, Zarbock A, Kleine-Bruggeney M, Stoppe C, Pearce K, Hughes M, Van Dyck L, Evans R, Montgomery HE, Elbourne D; TIGHT K investigators. Potassium Supplementation and Prevention of Atrial Fibrillation After Cardiac Surgery: The TIGHT K Randomized Clinical Trial. JAMA. 2024 Sep 24;332(12):979-988. doi: 10.1001/jama.2024.17888.

    PMID: 39215972RESULT

  • Campbell NG, Allen E, Evans R, Jamal Z, Opondo C, Sanders J, Sturgess J, Montgomery HE, Elbourne D, O'Brien B. Impact of maintaining serum potassium concentration >/= 3.6mEq/L versus >/= 4.5mEq/L for 120 hours after isolated coronary artery bypass graft surgery on incidence of new onset atrial fibrillation: Protocol for a randomized non-inferiority trial. PLoS One. 2024 Mar 13;19(3):e0296525. doi: 10.1371/journal.pone.0296525. eCollection 2024.

    PMID: 38478488DERIVED

MeSH Terms

Conditions

Arrhythmias, CardiacAtrial Fibrillation

Interventions

Potassium

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metals, AlkaliElementsInorganic ChemicalsMetals, LightMetals

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2019

First Posted

August 13, 2019

Study Start

October 20, 2020

Primary Completion

November 22, 2023

Study Completion

June 26, 2024

Last Updated

November 5, 2024

Record last verified: 2024-11

Locations

GB(1)