- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04053816
Prevention of Dysrhythmias on the Cardiac Intensive Care Unit - Does Maintenance of High-normal Serum Potassium Levels Matter (TIGHT-K)
The TIGHT-K STUDY. Prevention of Dysrhythmias on the Cardiac Intensive Care Unit - Does Maintenance of High-normal Serum Potassium Levels Matter
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
At least one in three patients is affected by atrial fibrillation after cardiac surgery(AFACS), with most episodes occurring in the first five postoperative days. AF occurrence is associated with increased morbidity, short and long-term mortality, intensive care unit (ICU) and hospital stay and cost of care. Persistence of these associations after adjustment for potential confounding factors suggests that they may be causal. The incidence and prevalence of AF and its associated costs are expected to increase as the surgical population ages. Extensive effort is undertaken to prevent AF after cardiac surgery from occurring, but clinical practice in this area is highly variable and the evidence base for most interventions is sparse.
Potassium plays an important role in cardiac electrophysiology. Serum potassium concentrations ([K+]) are commonly low following cardiac surgery, and appear marginally lower in those suffering atrial arrhythmias in non-surgical cohorts. Despite an absence of proof that this association is causal, efforts to maintain serum [K+] in the 'high-normal' range (≥ 4.5 mEq/L), as opposed to just intervening if potassium drops below its lower 'normal' threshold (<3.6 mEq/L), are considered 'routine practice' for AF prevention in post-surgical patients in many centres across the world.
From the (unpublished) data from our Tight-K Feasibility Study, all 160 patients would have required at least one dose of potassium to supplement their levels to this high-normal range and 45.5% of all serum [K+] measurements were below 4.5mEq/L at some point. Data from the same pilot study show a median number of potassium doses given in the 'tight' group (high-normal serum potassium target) of seven, compared to a median of one, with most patients not receiving any potassium supplementation at all, in the 'relaxed' group. This demonstrated for the first time ever, that the practice does achieve a separation in serum potassium levels between the two groups, so the protocol is indeed effective in achieving higher serum potassium levels.
The efficacy of the practice of maintaining high-normal serum potassium levels for the prevention of AF after cardiac surgery, however, remains unproven and data supporting it are extremely limited, being derived from observational studies rather than randomised trials. Indeed, no data exist to demonstrate that maintaining a high-normal potassium level is beneficial in these circumstances, or that aggressive replenishment of potassium in these patients improves outcome.
Meanwhile, potassium supplementation may cause discomfort or harm. Routine central venous potassium administration in the early post-operative period, when oral supplementation is not possible, is time-consuming, costly and associated with clinical risk: rapid infusion can prove fatal, and leaving central venous catheters in situ for the sole purpose of potassium replacement increases infection risk. Oral replacement (when feasible) is commonly associated with profound nausea and gastrointestinal side effects, and is very poorly tolerated by patients. The annual costs of intravenous potassium exceed those for other drugs in many cardiac surgical units due to the large quantities administered. Nursing time (e.g. for drug checks and administration) will add to this cost.
The routine maintenance of serum [K+] ≥ 4.5 mEq/L is a costly practice of unproven efficacy that is unpleasant and may be hazardous for patients. The investigators shall address this issue, performing the first appropriately powered non-inferiority multicentre randomised trial of potassium supplementation in patients undergoing coronary artery bypass surgery.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Professor Ben O'Brien
- Phone Number: 0207 927 2505
- Email: benobrien@doctors.org.uk
Study Contact Backup
- Name: Zahra Jamal
- Phone Number: 0207 927 2505
- Email: tightk@lshtm.ac.uk
Study Locations
-
-
London
-
London Borough of Sutton, London, United Kingdom, EC1A 7DN
- Barts Health NHS Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Scheduled to have isolated CABG surgery
- Patient in sinus rhythm
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Tight control
Patients randomised to the 'Tight' group will receive potassium supplementation if their serum potassium falls below 4.5 mEq/L (current practice).
|
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. |
Experimental: Relaxed control
Those randomised to the 'Relaxed' Group will receive potassium supplementation only if their serum potassium drops below 3.6 mEq/L.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: Maximum of 5 days
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
In-patient mortality
Time Frame: Maximum 6 months
|
Maximum 6 months
|
|
6-month mortality
Time Frame: Maximum 6 months
|
Maximum 6 months
|
|
Critical care length of stay
Time Frame: Maximum 6 months
|
Number of days patients are in inpatients in critical care
|
Maximum 6 months
|
Hospital length of stay
Time Frame: Maximum 6 months
|
Number of days patients are inpatients in all hospital wards
|
Maximum 6 months
|
Costs relating to potassium therapy
Time Frame: Maximum of 5 days
|
Financial cost of administering potassium therapy to patients
|
Maximum of 5 days
|
Quality of life at 6 months: questionnaire
Time Frame: 6 months
|
Quality of life questionnaire(EQ-5D-5L) administered before surgery and at 6 month follow up
|
6 months
|
The incidence of new onset AFACS
Time Frame: Maximum of 5 days
|
Detected on Holter monitor until hour 120 after initial admission to ICU/post-operative care facility or discharge from hospital, whichever occurs first.
|
Maximum of 5 days
|
The incidence of at least one episode of AFACS
Time Frame: Maximum of 5 days
|
Clinically identified AFACS or Holter-identified AFACS until hour 120 after initial admission to ICU/post-operative care facility or discharge from hospital, whichever occurs first.
|
Maximum of 5 days
|
Number of patients experiencing at least one episode of a non-AF arrhythmia.
Time Frame: Maximum of 5 days
|
Identified on Holter monitor until hour 120 after after initial admission to ICU/post-operative care facility or discharge from hospital, whichever occurs first
|
Maximum of 5 days
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 260639
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Arrhythmias, Cardiac
-
Medtronic BRCCompletedAtrial Fibrillation | Risk of Cardiac ArrhythmiasNetherlands, Germany, Austria, Belgium, Canada, Czech Republic, Russian Federation, Slovakia
-
Ostfold University CollegeNot yet recruitingCardiac Arrest | Cardiac Arrhythmia | Cardiac Disease | Cardiac Death
-
Medical University of LodzRecruiting
-
Centro Cardiologico MonzinoMinistry of Health, ItalyRecruitingCardiac ArrhythmiaItaly
-
Ratika ParkashCardiac Arrhythmia Network of CanadaRecruiting
-
Boston Scientific CorporationRecruitingCardiac ArrythmiasUnited States, Monaco, Italy
-
EPD Solutions, A Philips CompanyPhilips HealthcareTerminatedCardiac ArrhythmiaUnited States
-
EPD Solutions, A Philips CompanyWithdrawn
-
Zoll Medical CorporationCompletedCardiac ArrhythmiaUnited States
-
Emory UniversityCompleted
Clinical Trials on Potassium
-
Xijing HospitalCompletedCongenital Heart DiseaseChina
-
University of PennsylvaniaCompleted
-
University of PennsylvaniaNorthwestern UniversityCompleted
-
Samuel Lunenfeld Research Institute, Mount Sinai...Completed
-
University of PennsylvaniaCompletedHeart Failure | Diastolic Heart FailureUnited States
-
Federal University of UberlandiaCoordenação de Aperfeiçoamento de Pessoal de Nível Superior.; Fundação de Amparo...UnknownDentin Sensitivity | Dentin Hypersensitivity | Dentine Hypersensitivity | Hypersensitivity DentinBrazil
-
Aga Khan UniversityUnknownAcute HypokalemiaPakistan
-
Oxford Brookes UniversitySuntory Beverage & Food LimitedCompleted
-
University of DelawareRecruitingCardiovascular Risk FactorUnited States
-
University of DelawareCompleted