Trial Review

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000386639
Ethics application status
Approved
Date submitted
9/09/2005
Date registered
14/09/2005
Date last updated
6/11/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Frusemide infusion for the prevention of deterioration in renal function post cardiac surgery.
Scientific title
Frusemide infusion for the prevention of deterioration in renal function post cardiac surgery.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal impairment after cardiac surgery. 490 0
Condition category
Condition code
Surgery 569 569 0 0
Other surgery
Renal and Urogenital 570 570 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The frusemide infusion group- which will be monitored to achieve a trial specified hourly urine output target range of 1-2 ml/kg/hr. In order to achieve this target the patients may need to receive a loading dose of frusemide and may also require a frusemide infusion. The aim will be to maintain the urine output within the target range for the first 48 hours after cardiac surgery.
Intervention code [1] 447 0
Prevention
Comparator / control treatment
The control group- which will receive frusemide bolus doses if required as determined by surgeon/consultant physician.
Control group
Active

Outcomes
Primary outcome [1] 652 0
Incidence of increase in creatinine of 0.05 mmol/L or greater in the first 72 hours after cardiac surgery
Timepoint [1] 652 0
Secondary outcome [1] 1352 0
1.the maximum change in serum creatinine from baseline value
Timepoint [1] 1352 0
During the first 7 days of hospital stay
Secondary outcome [2] 1353 0
2.incidence of renal failure requiring any form of renal replacement therapy
Timepoint [2] 1353 0
Secondary outcome [3] 1354 0
3.Duration of post-operative hospital and ICU stay.
Timepoint [3] 1354 0
Secondary outcome [4] 1355 0
4.the maximum Sequential Organ Failure Assessment (SOFA) score
Timepoint [4] 1355 0
In the first 7 days of hospital stay

Eligibility
Key inclusion criteria
All patients admitted for cardiac surgery will be assessed for eligibility. Participants will be approached for inclusion from the pre-admission clinics, and wards of the Cardiothoracic surgery unit. Potential participants will be identified by daily review of planned cardiothoracic surgery schedules. Prior to inclusion in this study permission to approach patients will be obtained from involved treating Intensivists and Surgeons.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if:1.already in established dialysis dependent chronic renal failure.2.known allergy to frusemide. 3.age < 184.Pregnant.

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



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/11/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 620 0
Charities/Societies/Foundations
Name [1] 620 0
Intensive Care Research department Funding
Country [1] 620 0
Primary sponsor type
Hospital
Name
Intensive Care Unit, RMH
Address
Country
Australia
Secondary sponsor category [1] 505 0
None
Name [1] 505 0
Nil
Address [1] 505 0
Country [1] 505 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1736 0
Royal Melbourne Hospital
Ethics committee address [1] 1736 0
Ethics committee country [1] 1736 0
Australia
Date submitted for ethics approval [1] 1736 0
Approval date [1] 1736 0
Ethics approval number [1] 1736 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35345 0
Address 35345 0
Country 35345 0
Phone 35345 0
Fax 35345 0
Email 35345 0
Contact person for public queries
Name 9636 0
Dr J J Presneill
Address 9636 0
Intensive Care Unit
Royal Melbourne Hospital
Grattan Street
Parkville VIC 3050
Country 9636 0
Australia
Phone 9636 0
+61 3 93427441
Fax 9636 0
+61 3 93428812
Email 9636 0
[email protected]
Contact person for scientific queries
Name 564 0
Belinda Howe
Address 564 0
Intensive Care Unit
Royal Melbourne Hospital
Grattan Street
Parkville VIC 3050
Country 564 0
Australia
Phone 564 0
+61 3 93427710
Fax 564 0
+61 3 93428812
Email 564 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.