Pilot Study for the Tight K Study

NCT03195647 | Completed Phase 3 DMC

• 1 other identifier: 011660
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

Brief Summary

The primary purpose of this pilot study will be feasibility of recruitment. However, in order to further inform a full randomised controlled trial (RCT), information on the incidence of atrial fibrillation (AF) and other arrhythmias, hospital length of stay, resource use and morbidity will be collected.

Conditions

Cardiac Arrythmias

Keywords

cardiovascular; potassium supplementation; coronary artery by pass surgery

Outcome Measures

Primary Outcomes (4)

• Total number of patients recruited over a 6 month period

  The pilot study is being conducted to assess if it is feasible to recruit the required patient population into the study. The aim of the pilot is to recruit 160 patients over 6 months from two different centres.

  6 months

• Number of patients successfully randomised into the study to receive standard either usual care or control of potassium at the lower limit of the normal range

  The pilot study will investigate if it is feasible to randomised patients between the control and intervention arms of the study

  6 months

• Protocol violation rate

  Feasibility of ensuring that protocol violation rate is no more than 10%

  6 months

• Number of patient with outcome data at 28 days

  This is a feasibility and one of the main outcome will be to assess the number of participants with outcome data at 28 days. The study will aim to follow up 90% of the patients randomised.

  6 months

Secondary Outcomes (7)

• Incidence of new onset atrial fibrillation

  Maximum of 5 days

• Mean critical care length of stay

  Maximum 28 days

• Mean hospital length of stay

  Maximum 28 days

• Incidence of all other arrhythmias, defined using standard diagnostic criteria

  Maximum of 5 days

• Incidence of in-patient mortality

  28 days from randomisation

Study Arms (2)

Relaxed control

EXPERIMENTAL

Those randomised to the 'Relaxed' Group will receive potassium supplementation only if their serum potassium drops below or equals 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

Potassium DRUG

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 control; Tight Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. All patients undergoing isolated elective coronary artery bypass graft (CABG)

You may not qualify if:

• Age less than 18 years
• Previous AF
• Concurrent patient involvement in another clinical study assessing post-operative interventions
• On-going infection/sepsis at the time of operation
• Pre-op high-degree atrioventricular (AV) block
• Pre-op serum K+ greater than 5.5 mEq/L
• Current or previous use of medication for the purposes of cardiac rhythm management
• Dialysis dependent end stage renal failure

Sponsors & Collaborators

• Barts & The London NHS Trust: lead
• London School of Hygiene and Tropical Medicine: collaborator

Study Sites (2)

Barts Health NHS Trust

London, EC1A 7DN, United Kingdom

Location

St George's University Hospital London

London, United Kingdom

Location

Related Publications (1)

• Campbell NG, Allen E, Sanders J, Swinson R, Birch S, Sturgess J, Al-Subaie N, Elbourne D, Montgomery H, O'Brien B. 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. Trials. 2017 Dec 28;18(1):618. doi: 10.1186/s13063-017-2349-x.

  PMID: 29282098 DERIVED

MeSH Terms

Interventions

Potassium

Intervention Hierarchy (Ancestors)

Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals

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: May 23, 2017
• First Posted: June 22, 2017
• Study Start: August 1, 2017
• Primary Completion: April 24, 2018
• Study Completion: May 29, 2018
• Last Updated: July 16, 2020

Record last verified: 2018-06

Locations

GB (2)