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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Recruitment Status : Withdrawn (The study has ceased recruiting as Ethics approval has lapsed and the investigator availability reduced.)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
Sponsor:
Information provided by:
Melbourne Health

Tracking Information
First Submitted Date  ICMJE October 27, 2005
First Posted Date  ICMJE October 30, 2005
Last Update Posted Date April 27, 2015
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2005)
The incidence of increase in creatinine of 0.05 mmol/L or greater in the first 72 hours after cardiac surgery.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2005)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Frusemide Infusion for the Prevention of Deterioration in Renal Function Post Cardiac Surgery.
Official Title  ICMJE Frusemide Infusion for the Prevention of Deterioration of Renal Function in Post Cardiac Surgery
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Renal Impairment After Cardiac Surgery
Intervention  ICMJE Drug: Frusemide
Study Arms  ICMJE
  • Standard Care
    Patients will only receive frusemide as per the treating physicians treatment
    Intervention: Drug: Frusemide
  • Intervention
    Patients will be given frusemide to achieve a study specified urine output target of 1-2mls/kg/hour
    Intervention: Drug: Frusemide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 23, 2015)
0
Original Enrollment  ICMJE
 (submitted: October 27, 2005)
400
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00246675
Other Study ID Numbers  ICMJE 2002.167
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Melbourne Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John F Cade Royal Melbourne Hospital, Intensive Care Unit
PRS Account Melbourne Health
Verification Date April 2015

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