Comparison of Two Potassium Targets Within the Normal Range in Intensive Care Patients (GRIP-COMPASS)
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|ClinicalTrials.gov Identifier: NCT01085071|
Recruitment Status : Completed
First Posted : March 11, 2010
Last Update Posted : January 21, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Thoracic Surgery Cardiac Surgery Critically Ill||Drug: Potassium Chloride||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1225 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||GRIP-COMPASS Trial: Computer-driven Glucose and Potassium Regulation Program in Intensive Care Patients With COMparison of PotASSium Targets Within normokAlemic Range|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||January 2012|
Active Comparator: Normal-high potassium (NHP)
A potassium target of 4.5 mmol/L.
Drug: Potassium Chloride
KCl is continuously administered and titrated towards a Normal-high Potassium (4.5 mmol/L)
Active Comparator: Normal-low potassium (NLP)
A potassium target of 4.0 mmol/L.
Drug: Potassium Chloride
KCl is continuously administered and titrated towards a Normal-low Potassium (4.0 mmol/L)
- AFib or AFl in patients who underwent CABG (coronary artery bypass grafting) or valvular surgery. [ Time Frame: 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.
- Potassium regulation within 3.5 to 5.0 mmol/L. [ Time Frame: 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. [ Time Frame: 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). [ Time Frame: From ICU-admission to hospital discharge. ]
- Cumulative fluid balance. [ Time Frame: During ICU-stay. ]
- Mortality and (ICU) length of stay. [ Time Frame: ICU-mortality and hospital-mortality as well as 90-day mortality. ]
- Glucose regulation [ Time Frame: During ICU-admission. ]The relation with glucose levels and insulin administration
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01085071
|University Medical Center Groningen, University of Groningen|
|Groningen, Netherlands, 9700RB|
|Study Director:||Felix Zijlstra, MD/PhD||University Medical Center Groningen|
|Principal Investigator:||Maarten WN Nijsten, MD/PhD||University Medical Center Groningen|