Clinical trial NCT01085071: Comparison of Two Potassium Targets Within the Normal Range in Intensive Care Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Thoracic Surgery
Cardiac Surgery
Critically Ill
Keywords: intensive care unit
potassium
atrial fibrillation
cardiac surgery
Critically ill patients post CABG and/or valvular surgery
Critically ill patients not post CABG and/or valvular surgery
coronary artery bypass graft
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2010-03-11
Enrollment: 1225
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: AFib or AFl in patients who underwent CABG (coronary artery bypass grafting) or valvular surgery.
timeFrame: First 7d after Intensive Care Unit admission or hospital discharge, whichever is earlier.
Secondary outcomes:
measure: Potassium regulation within 3.5 to 5.0 mmol/L.
timeFrame: From Intensive Care Unit admission to hospital discharge.
measure: AFib or AFl in other patients, i.e. patients who did not undergo CABG or valvular surgery.
timeFrame: First 7d after ICU-admission or hospital discharge, whichever is earlier.
measure: Biochemical disturbances including electrolytes (Na, K, Mg, Ca), blood gas analysis, lactate, renal function (creatinine, urea).
timeFrame: From ICU-admission to hospital discharge.
measure: Cumulative fluid balance.
timeFrame: During ICU-stay.
measure: Mortality and (ICU) length of stay.
timeFrame: ICU-mortality and hospital-mortality as well as 90-day mortality.
measure: Glucose regulation
timeFrame: During ICU-admission.
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen, University of Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Felix Zijlstra, MD/PhD
role: STUDY_DIRECTOR
affiliation: University Medical Center Groningen
name: Maarten WN Nijsten, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1186/1472-6947-5-38.
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.
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.
citation: 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.
citation: 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.
citation: 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.