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Safety of Continuous Potassium Chloride Infusion in Critical Care (ASPIC)

This study has been completed.
Sponsor:
Information provided by:
The Queen Elizabeth Hospital
ClinicalTrials.gov Identifier:
NCT00718068
First received: July 16, 2008
Last updated: July 26, 2010
Last verified: November 2009
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessing the Safety of a Continuous Potassium Chloride Infusion in Critical Care: A Randomised Controlled Trial

Resource links provided by NLM:

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 ]

Enrollment: 160
Study Start Date: October 2008
Study Completion Date: October 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Continuous
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
Other Name: CAS no: 7447-40-7
Active Comparator: Intermittent
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
Other Name: CAS no: 7447-40-7

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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
Woodville South, South Australia, Australia, 5011
Sponsors and Collaborators
The Queen Elizabeth Hospital
Investigators
Principal Investigator: Richard Chalwin, FCICM The Queen Elizabeth Hospital
  More Information

No publications provided

Responsible Party: Dr Richard Chalwin, The Queen Elizabeth Hospital
ClinicalTrials.gov Identifier: NCT00718068     History of Changes
Other Study ID Numbers: 2007185
Study First Received: July 16, 2008
Last Updated: July 26, 2010
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:
Arrhythmias, Cardiac
Hypokalemia
Potassium Deficiency
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
 Water-Electrolyte Imbalance
Metabolic Diseases
Deficiency Diseases
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on May 21, 2013