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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:
Information provided by (Responsible Party):
Miriam Hoekstra, University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT01085071
First received: March 1, 2010
Last updated: January 18, 2013
Last verified: January 2013
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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:

U.S. FDA Resources

Further study details as provided by 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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
  • Cumulative fluid balance. [ Time Frame: During ICU-stay. ] [ Designated as safety issue: No ]
  • Mortality and (ICU) length of stay. [ Time Frame: ICU-mortality and hospital-mortality as well as 90-day mortality. ] [ Designated as safety issue: Yes ]
  • Glucose regulation [ Time Frame: During ICU-admission. ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01085071

Locations
Netherlands
University Medical Center Groningen, University of Groningen
Groningen, Netherlands, 9700RB
Sponsors and Collaborators
University Medical Centre Groningen
Investigators
Study Director: Felix Zijlstra, MD/PhD University Medical Centre Groningen
Principal Investigator: Maarten WN Nijsten, MD/PhD University Medical Centre Groningen
  More Information

Publications:

Responsible Party: Miriam Hoekstra, MD, University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT01085071     History of Changes
Other Study ID Numbers: GRIP-COMPASS trial
Study First Received: March 1, 2010
Last Updated: January 18, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by 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

ClinicalTrials.gov processed this record on May 23, 2013