Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000403437
Ethics application status
Approved
Date submitted
1/08/2007
Date registered
6/08/2007
Date last updated
18/09/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of pump prime on bicarbonate, unmeasured ions, and acid-base balance during and after cardiopulmonary bypass
Scientific title
Effect of pump prime on bicarbonate, unmeasured ions, and acid-base balance during and after cardiopulmonary bypass
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acid-base disorders 2206 0
Condition category
Condition code
Other 2301 2301 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients randomized to cardiopulmonary bypass primed with either 1500ml of Ringer’s Injection(Baxter, Sydney Australia): sodium 144 mmol/L, potassium 4 mmol/L , calcium 2 mmol/L , and chloride 152 mmol/L; OR 1500ml of Hartmann’s solution (Baxter, Sydney, Australia): sodium 129 mmol/L, potassium 5 mmol/L, calcium 2 mmol/L , chloride 109 mmol/L, and lactate 29 mmol/L .

Patients will recieve one dose only of either the Ringer's Injection prime or Hartmann's prime when cardiopulmonary bypass is initiated.
Intervention code [1] 1921 0
Treatment: Drugs
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 3193 0
The base-excess will be measured in arterial blood sampled before bypass and then 2, 5, 10, 15 and 30 minutes after initiating bypass; and then 5 minutes after ceasing bypass and on arrival in Intensive Care. The difference between the grand means of base-excess will be compared between the Ringer's Injection and Hartmann's groups.
Timepoint [1] 3193 0
Secondary outcome [1] 5324 0
Plasma electrolyte levels will be measured in arterial blood sampled before bypass and then 2, 5, 10, 15 and 30 minutes after initiating bypass; and then 5 minutes after ceasing bypass and on arrival in Intensive Care. The difference between the grand means of the electrolytes will be compared between the Ringer's Injection and Hartmann's groups.
Timepoint [1] 5324 0

Eligibility
Key inclusion criteria
Adults undergoing elective primary coronary artery bypass surgery.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient declines, age less than 18 years, age greater than 75 years, creatinine concentration greater than 150 micromoles/L, diabetes mellitus, anaemia (hemoglobin level <100g/L), pre-existing acid-base abnormalities, and extremes in weight (body weight <50kg or >100kg.

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)
All eligible patients approached prior to surgery. Allocation from opaque envelopes on day of surgery.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number table from hospital pharmacy
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Blinding: (subjects) patients; (clinicans) anaesthetists, medical perfusionists, surgeons.
Phase
Phase 4
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2464 0
Government body
Name [1] 2464 0
Department of Anaesthesia
Austin Health
Country [1] 2464 0
Australia
Funding source category [2] 2465 0
Government body
Name [2] 2465 0
Australian and New Zealand College of Anaesthetists (ANZCA)
Country [2] 2465 0
Primary sponsor type
Individual
Name
Associate Professor David Story
Austin Health
Address
Country
Australia
Secondary sponsor category [1] 2239 0
Individual
Name [1] 2239 0
Dr Frank Liskaser
Address [1] 2239 0
Country [1] 2239 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4346 0
Austin Health
Ethics committee address [1] 4346 0
Ethics committee country [1] 4346 0
Australia
Date submitted for ethics approval [1] 4346 0
Approval date [1] 4346 0
Ethics approval number [1] 4346 0

Summary
Brief summary
Study hypothesis: That priming the cardiopulmonary bypass pump with Hartmann's solution rather than Ringer's Injection will decrease the amount of acidosis associated with cardiopulmonary bypass.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27735 0
Address 27735 0
Country 27735 0
Phone 27735 0
Fax 27735 0
Email 27735 0
Contact person for public queries
Name 11110 0
Associate Professor David Story
Address 11110 0
Department of Anaesthesia
Austin Hospital
Studley Rd
Heidelberg VIC 3084
Country 11110 0
Australia
Phone 11110 0
+61 3 94963800
Fax 11110 0
+61 3 94596421
Email 11110 0
[email protected]
Contact person for scientific queries
Name 2038 0
Associate Professor David Story
Address 2038 0
Department of Anaesthesia
Austin Hospital
Studley Rd
Heidelberg VIC 3084
Country 2038 0
Australia
Phone 2038 0
+61 3 94963800
Fax 2038 0
+61 3 94596421
Email 2038 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.