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

Cardiac Surgery Clinical Trial

— GRIP-COMPASS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01085071
• Other study ID #: GRIP-COMPASS trial
• Status: Completed
• Phase: Phase 4
• First received: March 1, 2010
• Last updated: January 18, 2013
• Start date: June 2009
• Est. completion date: January 2012

Study information

• Verified date: January 2013
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1225
• Est. completion date: January 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Surgery
• Critical Illness
• Critically Ill
• Thoracic Surgery

Intervention

Drug:
• Potassium Chloride
KCl is continuously administered and titrated towards a Normal-high Potassium (4.5 mmol/L)
• Potassium Chloride
KCl is continuously administered and titrated towards a Normal-low Potassium (4.0 mmol/L)

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen, University of Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

References & Publications (4)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	Yes
Secondary	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.	No
Secondary	Biochemical disturbances including electrolytes (Na, K, Mg, Ca), blood gas analysis, lactate, renal function (creatinine, urea).		From ICU-admission to hospital discharge.	No
Secondary	Cumulative fluid balance.		During ICU-stay.	No
Secondary	Mortality and (ICU) length of stay.		ICU-mortality and hospital-mortality as well as 90-day mortality.	Yes
Secondary	Glucose regulation	The relation with glucose levels and insulin administration	During ICU-admission.	No