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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00718068