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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01085071
First Posted: March 11, 2010
Last Update Posted: January 21, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Miriam Hoekstra, University Medical Centre Groningen
  Purpose

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 Intervention Phase
Thoracic Surgery Cardiac Surgery Critically Ill Drug: Potassium Chloride Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: GRIP-COMPASS Trial: Computer-driven Glucose and Potassium Regulation Program in Intensive Care Patients With COMparison of PotASSium Targets Within normokAlemic Range

Resource links provided by NLM:


Further study details as provided by Miriam Hoekstra, University Medical Centre Groningen:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 1225
Study Start Date: June 2009
Study Completion Date: January 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Netherlands
University Medical Center Groningen, University of Groningen
Groningen, Netherlands, 9700RB
Sponsors and Collaborators
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
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Miriam Hoekstra, MD, University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT01085071     History of Changes
Other Study ID Numbers: GRIP-COMPASS trial
First Submitted: March 1, 2010
First Posted: March 11, 2010
Last Update Posted: January 21, 2013
Last Verified: January 2013

Keywords provided by Miriam Hoekstra, University Medical Centre Groningen:
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

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes