Frusemide Infusion for the Prevention of Deterioration in Renal Function Post Cardiac Surgery.

• ClinicalTrials.gov Identifier: NCT00246675
• Recruitment Status: Withdrawn
• First Posted: October 30, 2005
• Last Update Posted: April 27, 2015
• Sponsor: Melbourne Health
• Information provided by: Melbourne Health

Tracking Information

• First Submitted Date: October 27, 2005
• First Posted Date: October 30, 2005
• Last Update Posted Date: April 27, 2015
• Study Start Date: Not Provided
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Frusemide Infusion for the Prevention of Deterioration in Renal Function Post Cardiac Surgery.
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Renal Impairment After Cardiac Surgery
• Intervention: Drug: Frusemide

Study Arms

• 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

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: April 23, 2015): 0
• Original Enrollment (submitted: October 27, 2005): 400
• Study Completion Date: Not Provided
• Primary Completion Date: Not Provided

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia

Administrative Information

• NCT Number: NCT00246675
• Other Study ID Numbers: 2002.167
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Melbourne Health
• Collaborators: Not Provided

Investigators

• Principal Investigator: John F Cade; Royal Melbourne Hospital, Intensive Care Unit

• PRS Account: Melbourne Health
• Verification Date: April 2015