Safety of Continuous Potassium Chloride Infusion in Critical Care - Full Text View

Sponsor:	The Queen Elizabeth Hospital
Information provided by:	The Queen Elizabeth Hospital
ClinicalTrials.gov Identifier:	NCT00718068

Purpose

Patients in critical care often require supplemental potassium chloride if levels in their blood are below acceptable level. Common practice is to administer a single dose of potassium chloride under controlled conditions via a drip, before checking if a further dose is required. The purpose of this study is to ensure that it is safe to administer potassium chloride continuously with the dose varied according to patient needs.

Condition	Intervention	Phase
Hypokalemia Arrhythmias, Cardiac	Drug: Sterile Potassium Chloride Concentrate	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Assessing the Safety of a Continuous Potassium Chloride Infusion in Critical Care: A Randomised Controlled Trial

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Arrhythmia Critical Care

Drug Information available for: Chlorides Potassium chloride

U.S. FDA Resources

Further study details as provided by The Queen Elizabeth Hospital:

Primary Outcome Measures:

Adherence to a potassium level 4.0 - 4.5mmol/L [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Total quantity of potassium administered [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Incidence of potassium level < 3.0mmol/L and > 5.5mmol/L [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
Incidence of arrhythmia [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
Number of arterial blood gases taken [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	140
Study Start Date:	October 2008
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Continuous: Experimental This group will receive potassium chloride by continuous infusion on a sliding-scale system based on serum potassium level.	Drug: Sterile Potassium Chloride Concentrate Continuous infusion, 40mmol in 40ml, starting at 10ml/hr, rate altered according to serum potassium level checked 2 hourly
Intermittent: Active Comparator This arm will form the control group and receive potassium chloride by intermittent infusion as per conventional management	Drug: Sterile Potassium Chloride Concentrate By intermittent infusion, 20mmol diluted in 100ml 0.9% NaCl, administered over 60 mins, serum potassium level checked 2 hourly, and repeat doses administered as appropriate

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Any inpatient on the investigating unit with a serum potassium level of less than 3.8mmol/L
arterial line for blood sampling and central venous access for infusion administration in situ
continuous 12-lead ECG monitoring

Exclusion Criteria:

Patients with a serum potassium ≥ 3.8mmol/L
Renal dysfunction with serum creatinine 50% greater than the upper end of the normal reference range (i.e.: > 180micromol/L) or urine output less than 0.5ml/kg/hr for 6 consecutive hours, or the requirement for dialysis
Burns
Hypomagnesaemia (≤ 0.7mmol/L), however patients may be enrolled after the hypomagnesaemia is corrected

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00718068

Locations

Australia, South Australia
The Queen Elizabeth Hospital	Recruiting
Woodville South, South Australia, Australia, 5011
Contact: Richard Chalwin, MBChB +61882224000 richard.chalwin@health.sa.gov.au
Contact: Patricia Williams, RN ICC +61882226000 patricia.williams@health.sa.gov.au
Principal Investigator: Richard Chalwin, MBChB

Sponsors and Collaborators

The Queen Elizabeth Hospital

Investigators

Principal Investigator:

Richard Chalwin, MBChB

The Queen Elizabeth Hospital

More Information

No publications provided

Responsible Party:	The Queen Elizabeth Hospital ( Dr Richard Chalwin )
Study ID Numbers:	2007185
Study First Received:	July 16, 2008
Last Updated:	September 17, 2009
ClinicalTrials.gov Identifier:	NCT00718068 History of Changes
Health Authority:	Australia: Human Research Ethics Committee

Keywords provided by The Queen Elizabeth Hospital:

Potassium chloride
Preparations, Pharmaceutical
Hypokalemia

Critical Care
Adult
Randomized Controlled Trial

Additional relevant MeSH terms:

Metabolic Diseases
Pathologic Processes
Heart Diseases
Hypokalemia

Water-Electrolyte Imbalance
Cardiovascular Diseases
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on November 22, 2009