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

Study Overview
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Brief Summary
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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.

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

Conditions
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Thoracic Surgery, Cardiac Surgery, Critically Ill

Intervention / Treatment
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* Drug: Potassium Chloride
* Drug: Potassium Chloride


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Normal-high potassium (NHP)<br>A potassium target of 4.5 mmol/L. | Drug: Potassium Chloride<br>* KCl is continuously administered and titrated towards a Normal-high Potassium (4.5 mmol/L)<br>|
| Active Comparator: Normal-low potassium (NLP)<br>A potassium target of 4.0 mmol/L. | Drug: Potassium Chloride<br>* KCl is continuously administered and titrated towards a Normal-low Potassium (4.0 mmol/L)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| Biochemical disturbances including electrolytes (Na, K, Mg, Ca), blood gas analysis, lactate, renal function (creatinine, urea). |  | From ICU-admission to hospital discharge. | 
| Cumulative fluid balance. |  | During ICU-stay. | 
| Mortality and (ICU) length of stay. |  | ICU-mortality and hospital-mortality as well as 90-day mortality. | 
| Glucose regulation | The relation with glucose levels and insulin administration | During ICU-admission. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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