Frusemide Infusion for the Prevention of Deterioration in Renal Function Post Cardiac Surgery.
|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 evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00246675|
Recruitment Status : Withdrawn (The study has ceased recruiting as Ethics approval has lapsed and the investigator availability reduced.)
First Posted : October 30, 2005
Last Update Posted : April 27, 2015
|Condition or disease||Intervention/treatment||Phase|
|Renal Impairment After Cardiac Surgery||Drug: Frusemide||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Frusemide Infusion for the Prevention of Deterioration of Renal Function in Post Cardiac Surgery|
Patients will only receive frusemide as per the treating physicians treatment
Patients will be given frusemide to achieve a study specified urine output target of 1-2mls/kg/hour
- The incidence of increase in creatinine of 0.05 mmol/L or greater in the first 72 hours after cardiac surgery.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00246675
|Intensive Care Unit, Royal Melbourne Hospital|
|Parkville, Victoria, Australia, 3050|
|Principal Investigator:||John F Cade||Royal Melbourne Hospital, Intensive Care Unit|