Comparison of Two Potassium Targets Within the Normal Range in Intensive Care Patients

Phase 4

Completed

• Conditions: Thoracic Surgery; Cardiac Surgery; Critically Ill
• Interventions: Drug: Potassium Chloride

• Registration Number: NCT01085071
• Lead Sponsor: University Medical Center Groningen

Brief Summary

Rationale: It is well known that distinctly abnormal blood potassium values can cause serious complications such as cardiac arrhythmias. Although potassium regulation is generally considered important, hardly any research has been done about potassium regulation in intensive care patients. The investigators hypothesize that different potassium target-values, within the as normal accepted range, may have different effects in critically ill patients.

Study design: A prospective trial comparing two different potassium target-values. Potassium will be tightly regulated with the already fully operational GRIP-II computer program.

Study population: 1200 adult patients admitted at the thoracic intensive care unit of the University Medical Center Groningen.

Intervention: Comparison between two variations of standard therapy: potassium target-value of 4.0 mmol/L versus 4.5 mmol/L.

Main study parameters/endpoints: The primary endpoint is the incidence of atrial fibrillation or atrial flutter from ICU-admission to hospital discharge. Secondary endpoints are serum levels of potassium and the other main electrolytes, renal function and renal potassium excretion, the relation with insulin and glucose, the cumulative fluid balance, (ICU) length of stay and mortality.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2010-03-01
• Study First Submitted QC: 2010-03-10
• Study First Posted: 2010-03-11
• Primary Completion: 2011-12
• Study Completion: 2012-01
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-18
• Last Update Posted: 2013-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1225

Inclusion Criteria

• All adult patients admitted to the thoracic and surgical ICU of the University Medical Center Groningen.
• Computerized potassium regulation with GRIP-II

Exclusion Criteria

• Patients who are not potassium regulated with GRIP-II (patients who take their own meals).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal-high potassium (NHP)	Potassium Chloride	A potassium target of 4.5 mmol/L.
Normal-low potassium (NLP)	Potassium Chloride	A potassium target of 4.0 mmol/L.

Primary Outcome Measures

Name	Time	Method
AFib or AFl in patients who underwent CABG (coronary artery bypass grafting) or valvular surgery.	First 7d after Intensive Care Unit admission or hospital discharge, whichever is earlier.	Post-surgery AFib and AFl typically occur within days after surgery. AFib and AFl can only be reliably assessed during ICU stay and hospital stay. Therefore this outcome measure is not determined after hospital discharge.

Secondary Outcome Measures

Name	Time	Method
Potassium regulation within 3.5 to 5.0 mmol/L.	From Intensive Care Unit admission to hospital discharge.	Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
AFib or AFl in other patients, i.e. patients who did not undergo CABG or valvular surgery.	First 7d after ICU-admission or hospital discharge, whichever is earlier.	Post-surgery AFib and AFl typically occur within days after surgery. AFib and AFl can only be reliably assessed during ICU stay and hospital stay. Therefore this outcome measure is not determined after hospital discharge.
Biochemical disturbances including electrolytes (Na, K, Mg, Ca), blood gas analysis, lactate, renal function (creatinine, urea).	From ICU-admission to hospital discharge.
Cumulative fluid balance.	During ICU-stay.
Mortality and (ICU) length of stay.	ICU-mortality and hospital-mortality as well as 90-day mortality.
Glucose regulation	During ICU-admission.	The relation with glucose levels and insulin administration

Trial Locations

Locations (1)

University Medical Center Groningen, University of Groningen; 🇳🇱 Groningen, Netherlands