Frusemide Infusion for the Prevention of Deterioration in Renal Function Post Cardiac Surgery.
Information source: Melbourne Health
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Renal Impairment After Cardiac Surgery
Intervention: Frusemide (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Melbourne Health Official(s) and/or principal investigator(s):
John Francis Cade, Principal Investigator, Affiliation: Royal Melbourne Hospital, Intensive Care Unit
Overall contact:
Jeffrey John Presneill, MBBS, Phone: + 61 3 93427441, Email: jeffrey.presneill@mh.org.au
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.
Clinical Details
Official title: Frusemide Infusion for the Prevention of Deterioration of Renal Function in Post Cardiac Surgery
Study design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The incidence of increase in creatinine of 0.05 mmol/L or greater in the first 72 hours after cardiac surgery.
Secondary outcome: 1. The maximum change in serum creatinine from baseline value during the first 7 days of hospital stay.2. Incidence of renal failure requiring any form of renal replacement therapy. 3. Duration of post-operative hospital and ICU stay. 4. The maximum Sequential Organ Failure Assessment (SOFA) score in the first 7 days of hospital stay.
Detailed description:
All patients will receive standard supportive care based on current established management
practice of cardio-thoracic patients. The only difference in treatment will be the
randomisation of patients to receive/not receive protocolised administration of frusemide
targeting a urine output.
There will be 2 groups of patients. The control group-which will receive frusemide bolus
doses if required as determined by the surgeon/consultant physician. The frusemide infusion
group-which will be monitored to achieve a trial specified hourly urine output target range
of 1-2mls/kg/hour. In order to achieve this target the patient may need to receive a loading
dose of frusemide and may also then 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Exclusion Criteria:
1. Already in established dialysis dependent chronic renal failure.
2. Known allergy to frusemide
3. Age < 18 years
4. Pregnant
Locations and Contacts
Jeffrey John Presneill, MBBS, Phone: + 61 3 93427441, Email: jeffrey.presneill@mh.org.au
Intensive Care Unit, Royal Melbourne Hospital, Parkville, Victoria 3050, Australia
Additional Information
Starting date: January 2006
Last updated: December 21, 2005
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