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NCT00246675 Clinical Trial

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

Renal Impairment After Cardiac Surgery Clinical Trial

Official title:
Frusemide Infusion for the Prevention of Deterioration of Renal Function in Post Cardiac Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00246675
Other study ID # 2002.167
Secondary ID
Status Withdrawn
Phase N/A
First received October 27, 2005
Last updated April 23, 2015

Study information
Verified date April 2015
Source Melbourne Health
Contact n/a
Is FDA regulated No
Health authority Australia: Department of Health and Ageing Therapeutic Goods Administration
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Frusemide

Locations
Country Name City State
Australia Intensive Care Unit, Royal Melbourne Hospital Parkville Victoria

Sponsors (1)
Lead Sponsor Collaborator
Melbourne Health

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary The incidence of increase in creatinine of 0.05 mmol/L or greater in the first 72 hours after cardiac surgery.
Secondary 1. The maximum change in serum creatinine from baseline value during the first 7 days of hospital stay.
Secondary 2. Incidence of renal failure requiring any form of renal replacement therapy.
Secondary 3. Duration of post-operative hospital and ICU stay.
Secondary 4. The maximum Sequential Organ Failure Assessment (SOFA) score in the first 7 days of hospital stay.