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Frusemide Infusion for the Prevention of Deterioration in Renal Function Post Cardiac Surgery.
This study has been withdrawn prior to recruitment.
( The study has ceased recruiting as Ethics approval has lapsed and the investigator availability reduced. )
Study NCT00246675   Information provided by Melbourne Health
First Received: October 27, 2005   Last Updated: February 3, 2009   History of Changes

October 27, 2005
February 3, 2009
 
 
The incidence of increase in creatinine of 0.05 mmol/L or greater in the first 72 hours after cardiac surgery.
Same as current
Complete list of historical versions of study NCT00246675 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
 
Frusemide Infusion for the Prevention of Deterioration in Renal Function Post Cardiac Surgery.
Frusemide Infusion for the Prevention of Deterioration of Renal Function in Post Cardiac Surgery

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.

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.

 
Interventional
Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Renal Impairment After Cardiac Surgery
Drug: Frusemide
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Withdrawn
400
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00246675
 
2002.167
Melbourne Health
 
Principal Investigator: John F Cade Royal Melbourne Hospital, Intensive Care Unit
Melbourne Health
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP