Comparison of Two Potassium Targets Within the Normal Range in Intensive Care Patients (GRIP-COMPASS)

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Surgery; Critically Ill; Thoracic Surgery
• Intervention / Treatment: Drug: Potassium Chloride; Drug: Potassium Chloride

• Study Type: Interventional
• Enrollment (Actual): 1225
• Phase: Phase 4

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9700RB
    • University Medical Center Groningen, University of Groningen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); Drug: Potassium Chloride; KCl is continuously administered and titrated towards a Normal-low Potassium (4.0 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-high Potassium (4.5 mmol/L); Drug: Potassium Chloride; KCl is continuously administered and titrated towards a Normal-low Potassium (4.0 mmol/L)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AFib or AFl in patients who underwent CABG (coronary artery bypass grafting) or valvular surgery.	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.	First 7d after Intensive Care Unit admission or hospital discharge, whichever is earlier.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Potassium regulation within 3.5 to 5.0 mmol/L.	Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.	From Intensive Care Unit admission to hospital discharge.
AFib or AFl in other patients, i.e. patients who did not undergo CABG or valvular surgery.	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.	First 7d after ICU-admission or hospital discharge, whichever is earlier.
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	The relation with glucose levels and insulin administration	During ICU-admission.

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Investigators: Study Director: Felix Zijlstra, MD/PhD, University Medical Center Groningen; Principal Investigator: Maarten WN Nijsten, MD/PhD, University Medical Center Groningen

Publications and helpful links

General Publications

• Vogelzang M, Zijlstra F, Nijsten MW. Design and implementation of GRIP: a computerized glucose control system at a surgical intensive care unit. BMC Med Inform Decis Mak. 2005 Dec 19;5:38. doi: 10.1186/1472-6947-5-38.
• Vogelzang M, Loef BG, Regtien JG, van der Horst IC, van Assen H, Zijlstra F, Nijsten MW. Computer-assisted glucose control in critically ill patients. Intensive Care Med. 2008 Aug;34(8):1421-7. doi: 10.1007/s00134-008-1091-y. Epub 2008 Apr 4.
• Hoekstra M, Vogelzang M, Verbitskiy E, Nijsten MW. Health technology assessment review: Computerized glucose regulation in the intensive care unit--how to create artificial control. Crit Care. 2009;13(5):223. doi: 10.1186/cc8023. Epub 2009 Oct 16.
• Hoekstra M, Vogelzang M, Drost JT, Janse M, Loef BG, van der Horst IC, Zijlstra F, Nijsten MW. Implementation and evaluation of a nurse-centered computerized potassium regulation protocol in the intensive care unit--a before and after analysis. BMC Med Inform Decis Mak. 2010 Jan 25;10:5. doi: 10.1186/1472-6947-10-5.
• Hoekstra M, Hessels L, Rienstra M, Yeh L, Lansink AO, Vogelzang M, van der Horst IC, van der Maaten JM, Mariani MA, de Smet AM, Struys MM, Zijlstra F, Nijsten MW. Computer-guided normal-low versus normal-high potassium control after cardiac surgery: No impact on atrial fibrillation or atrial flutter. Am Heart J. 2016 Feb;172:45-52. doi: 10.1016/j.ahj.2015.10.020. Epub 2015 Nov 11.
• Hoekstra M, Vogelzang M, van der Horst IC, Lansink AO, van der Maaten JM, Ismael F, Zijlstra F, Nijsten MW. Trial design: Computer guided normal-low versus normal-high potassium control in critically ill patients: Rationale of the GRIP-COMPASS study. BMC Anesthesiol. 2010 Dec 31;10:23. doi: 10.1186/1471-2253-10-23.

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: March 1, 2010
• First Submitted That Met QC Criteria: March 10, 2010
• First Posted (Estimate): March 11, 2010

Study Record Updates

• Last Update Posted (Estimate): January 21, 2013
• Last Update Submitted That Met QC Criteria: January 18, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: intensive care unit; cardiac surgery; atrial fibrillation; coronary artery bypass graft; potassium; Critically ill patients post CABG and/or valvular surgery; Critically ill patients not post CABG and/or valvular surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: GRIP-COMPASS trial

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No