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Completed

NCT Number: NCT01085071

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

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Medical Center Groningen, University of Groningen

Groningen, Provincie Groningen, 9700RB, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Potassium Chloride

Drug

KCl is continuously administered and titrated towards a Normal-high Potassium (4.5 mmol/L)

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. Biochemical disturbances including electrolytes (Na, K, Mg, Ca), blood gas analysis, lactate, renal function (creatinine, urea).

    Time frame: From ICU-admission to hospital discharge.

  4. Cumulative fluid balance.

    Time frame: During ICU-stay.

  5. Mortality and (ICU) length of stay.

    Time frame: ICU-mortality and hospital-mortality as well as 90-day mortality.

  6. Glucose regulation

    Time frame: During ICU-admission.

    The relation with glucose levels and insulin administration

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

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

Acronym: GRIP-COMPASS

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Mar 11, 2010
Registry last updated
Jan 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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