NCT01085071

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

GRIP-COMPASS Trial: Computer-driven Glucose and Potassium Regulation Program in Intensive Care Patients With COMparison of PotASSium Targets Within normokAlemic Range

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,225 (actual)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Thoracic Surgery
• Cardiac Surgery
• Critically Ill

Interventions

Type	Name	Description
DRUG	Potassium Chloride	KCl is continuously administered and titrated towards a Normal-high Potassium (4.5 mmol/L)
DRUG	Potassium Chloride	KCl is continuously administered and titrated towards a Normal-low Potassium (4.0 mmol/L)

Timeline

• Start date: 2009-06-01
• Primary completion: 2011-12-01
• Completion: 2012-01-01
• First posted: 2010-03-11
• Last updated: 2013-01-21

Locations

1 site across 1 country: Netherlands