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Trial registered on ANZCTR


Registration number
ACTRN12610000267055
Ethics application status
Approved
Date submitted
24/03/2010
Date registered
31/03/2010
Date last updated
31/03/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
A trial of Plasmalyte vs Bicarbonate based prime in patients undergoing cardiopulmonary bypass
Scientific title
Quantification of the role of acetate and gluconate to the changes in anion gap and strong ion gap caused by Plasmalyte 148 cardiopulmonary bypass pump prime: A comparison with bicarbonate
Secondary ID [1] 1550 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acid base abnormalities 257028 0
Inflammation 257041 0
Condition category
Condition code
Cardiovascular 257186 257186 0 0
Coronary heart disease
Surgery 257201 257201 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients undergoing cardiopulmonarybypass will receive a pump prime of 2 litres of bicarbonate based prime . The bicarbonate based prime has the following composition.(Sodium (Na) 140 mmol/L, Chloride (Cl) 116 mmol/L and bicarbonate 24 mmol/L). The pump flow rates and the membrane oxygenator protocls will be as per standard practice.
Intervention code [1] 256200 0
Treatment: Drugs
Comparator / control treatment
The control group will receive the normal pump prime which is Plasmalyte A at the volume of 2 litres and the composition of plasmalyte is Na 140 mmol/L, Cl 98 mmol/L, Magnesium (Mg) 3 mmol/L, Potassium (K) 5 mmol/L, Acetate 27 mmol/L, gluconate 23 mmol/L. The pump flow rates and the membrane oxygenator protocls will be as per standard practice.
Control group
Active

Outcomes
Primary outcome [1] 258079 0
Relationship between plasma acetate and gluconate versus changes in anion gap and strong ion gap (assessed through a simple blood test)
Timepoint [1] 258079 0
Prebypass
Immediately after bypass ( 2 min after going on cardiopulmonary bypass)
End of bypass ( at the time of liberation from cardiopulmonary bypass)
4 hrs post bypass
Secondary outcome [1] 263661 0
Relationship between plasma acetate and gluconate vs plasma IL-6 ( interleukin 6)
Timepoint [1] 263661 0
Prebypass
Immediately after bypass ( 2 min after going on cardiopulmonary bypass)
End of bypass ( at the time of liberation from cardiopulmonary bypass)
4 hrs post bypass
Secondary outcome [2] 263662 0
Relationship between plasma acetate and gluconate ( assessed through blood analysis) vs vasopresor dose and atrial fibrillation ( information obtained from Intensive Care Unit and ward charts)
Timepoint [2] 263662 0
Post bypass
Days 1,2,3,4,5 on ward

Eligibility
Key inclusion criteria
Patients undergoing elective or urgent coronary artery bypass grafting
Minimum age
18 Years
Maximum age
90 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Re-do cardiac surgery
Emergent surgery
Renal failure
Inability to provide informed consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256698 0
Self funded/Unfunded
Name [1] 256698 0
Address [1] 256698 0
Country [1] 256698 0
Primary sponsor type
Hospital
Name
Princess Alexandra hospital
Address
Ipswich rd
Woolloongabba
QLD 4102
Country
Australia
Secondary sponsor category [1] 255985 0
None
Name [1] 255985 0
Address [1] 255985 0
Country [1] 255985 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258716 0
Princess Alexandra Hospital Research Ethics Committee
Ethics committee address [1] 258716 0
Ipswich road
Woolloongabba
QLD 4102
Ethics committee country [1] 258716 0
Australia
Date submitted for ethics approval [1] 258716 0
Approval date [1] 258716 0
15/01/2009
Ethics approval number [1] 258716 0
2009/001

Summary
Brief summary
Heart operations is frequently accompanied by a degree of inflammation and irregular heart beat.This study aims to determine if the use of a solution containing bicarbonate during heart operations will reduce the amount of inflammation and improve heart rhythm.

During heart bypass surgery, patients' circulation is supported by a heart lung machine. During this process, the patient's blood is mixed with around 2 L of fluid. In Brisbane, we have developed a fluid for use during heart surgery. Initial results suggest that it maintains the acid levels in the blood better than the conventionally used fluid. This project is seeking to determine whether the new fluid also improves the overall well being of the patient.

If shown to improve the overall well being of the patient, it has the potential to reduce hospital stay and hospital costs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30977 0
Address 30977 0
Country 30977 0
Phone 30977 0
Fax 30977 0
Email 30977 0
Contact person for public queries
Name 14224 0
Prof Bala Venkatesh
Address 14224 0
Department of intensive Care
Princess Alexandra hospital
Ipswich rd
Woolloongabba
QLD 4102
Country 14224 0
Australia
Phone 14224 0
+61732402111
Fax 14224 0
+61732407074
Email 14224 0
bala_venkatesh@health.qld.gov.au
Contact person for scientific queries
Name 5152 0
Prof Bala Venkatesh
Address 5152 0
Department of intensive Care
Princess Alexandra hospital
Ipswich rd
Woolloongabba
QLD 4102
Country 5152 0
Australia
Phone 5152 0
+61732402111
Fax 5152 0
+61732407074
Email 5152 0
bala_venkatesh@health.qld.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary