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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2012-01-31

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.

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Detailed Description

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Conditions

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Thoracic Surgery Cardiac Surgery Critically Ill

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Normal-high potassium (NHP)

A potassium target of 4.5 mmol/L.

Group Type ACTIVE_COMPARATOR

Potassium Chloride

Intervention Type DRUG

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

Normal-low potassium (NLP)

A potassium target of 4.0 mmol/L.

Group Type ACTIVE_COMPARATOR

Potassium Chloride

Intervention Type DRUG

KCl is continuously administered and titrated towards a Normal-low Potassium (4.0 mmol/L)

Interventions

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Potassium Chloride

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

Intervention Type DRUG

Potassium Chloride

KCl is continuously administered and titrated towards a Normal-low Potassium (4.0 mmol/L)

Intervention Type DRUG

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