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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Recruitment Status : Withdrawn (The study has ceased recruiting as Ethics approval has lapsed and the investigator availability reduced.)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 31, 2005
Last Update Posted : April 27, 2015
Sponsor:
Information provided by:
Melbourne Health

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.

Condition or disease Intervention/treatment Phase
Renal Impairment After Cardiac Surgery Drug: Frusemide Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Frusemide Infusion for the Prevention of Deterioration of Renal Function in Post Cardiac Surgery

Resource links provided by the National Library of Medicine

Drug Information available for: Furosemide

Arm Intervention/treatment
Standard Care
Patients will only receive frusemide as per the treating physicians treatment
Drug: Frusemide
Intervention
Patients will be given frusemide to achieve a study specified urine output target of 1-2mls/kg/hour
Drug: Frusemide



Primary Outcome Measures :
  1. The incidence of increase in creatinine of 0.05 mmol/L or greater in the first 72 hours after cardiac surgery.

Secondary Outcome Measures :
  1. 1. The maximum change in serum creatinine from baseline value during the first 7 days of hospital stay.
  2. 2. Incidence of renal failure requiring any form of renal replacement therapy.
  3. 3. Duration of post-operative hospital and ICU stay.
  4. 4. The maximum Sequential Organ Failure Assessment (SOFA) score in the first 7 days of hospital stay.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Australia, Victoria
Intensive Care Unit, Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Sponsors and Collaborators
Melbourne Health
Investigators
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Principal Investigator: John F Cade Royal Melbourne Hospital, Intensive Care Unit

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ClinicalTrials.gov Identifier: NCT00246675     History of Changes
Other Study ID Numbers: 2002.167
First Posted: October 31, 2005    Key Record Dates
Last Update Posted: April 27, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases
Furosemide
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action