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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00718068




Registration number
NCT00718068
Ethics application status
Date submitted
16/07/2008
Date registered
18/07/2008
Date last updated
27/07/2010

Titles & IDs
Public title
Safety of Continuous Potassium Chloride Infusion in Critical Care
Scientific title
Assessing the Safety of a Continuous Potassium Chloride Infusion in Critical Care: A Randomised Controlled Trial
Secondary ID [1] 0 0
2007185
Universal Trial Number (UTN)
Trial acronym
ASPIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypokalemia 0 0
Arrhythmias, Cardiac 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders
Diet and Nutrition 0 0 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sterile Potassium Chloride Concentrate
Treatment: Drugs - Sterile Potassium Chloride Concentrate

Experimental: Continuous - This group will receive potassium chloride by continuous infusion on a sliding-scale system based on serum potassium level.

Active Comparator: Intermittent - This arm will form the control group and receive potassium chloride by intermittent infusion as per conventional management


Treatment: Drugs: Sterile Potassium Chloride Concentrate
Continuous infusion, 40mmol in 40ml, starting at 10ml/hr, rate altered according to serum potassium level checked 2 hourly

Treatment: Drugs: 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adherence to a potassium level 4.0 - 4.5mmol/L
Timepoint [1] 0 0
7 days
Secondary outcome [1] 0 0
Total quantity of potassium administered
Timepoint [1] 0 0
7 days
Secondary outcome [2] 0 0
Incidence of potassium level < 3.0mmol/L and > 5.5mmol/L
Timepoint [2] 0 0
7 days
Secondary outcome [3] 0 0
Incidence of arrhythmia
Timepoint [3] 0 0
7 days
Secondary outcome [4] 0 0
Number of arterial blood gases taken
Timepoint [4] 0 0
7 days

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2009
Sample size
Target
Accrual to date
Final
160
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment postcode(s) [1] 0 0
5011 - Woodville South

Funding & Sponsors
Primary sponsor type
Other
Name
The Queen Elizabeth Hospital
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00718068
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Richard Chalwin, FCICM
Address 0 0
The Queen Elizabeth Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00718068