Trial Review

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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/NCT00246675




Registration number
NCT00246675
Ethics application status
Date submitted
27/10/2005
Date registered
30/10/2005
Date last updated
27/04/2015

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 of Renal Function in Post Cardiac Surgery
Secondary ID [1] 0 0
2002.167
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Impairment After Cardiac Surgery 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Frusemide

Other: Standard Care - Patients will only receive frusemide as per the treating physicians treatment

Other: Intervention - Patients will be given frusemide to achieve a study specified urine output target of 1-2mls/kg/hour


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

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

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 the daily review
of planned cardiothoracic surgery schedule.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Already in established dialysis dependent chronic renal failure.

2. Known allergy to frusemide

3. Age < 18 years

4. 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)
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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
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
0
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Intensive Care Unit, Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
3050 - Parkville

Funding & Sponsors
Primary sponsor type
Other
Name
Melbourne Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the project is to test whether or not the commonly used medication frusemide,
given after heart surgery, and aiming to increase urinary output can have an effect on kidney
function.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00246675
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
John F Cade
Address 0 0
Royal Melbourne Hospital, Intensive Care Unit
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/NCT00246675