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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00718068
First Posted: July 18, 2008
Last Update Posted: July 27, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
The Queen Elizabeth Hospital
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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 ]

Secondary Outcome Measures:
  • Total quantity of potassium administered [ Time Frame: 7 days ]
  • Incidence of potassium level < 3.0mmol/L and > 5.5mmol/L [ Time Frame: 7 days ]
  • Incidence of arrhythmia [ Time Frame: 7 days ]
  • Number of arterial blood gases taken [ Time Frame: 7 days ]

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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr Richard Chalwin, The Queen Elizabeth Hospital
ClinicalTrials.gov Identifier: NCT00718068     History of Changes
Other Study ID Numbers: 2007185
First Submitted: July 16, 2008
First Posted: July 18, 2008
Last Update Posted: July 27, 2010
Last Verified: November 2009

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