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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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00246675
Enrollment
0
Registered
2005-10-31
Start date
Unknown
Completion date
Unknown
Last updated
2015-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Impairment After 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.

Interventions

Sponsors

Melbourne Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The incidence of increase in creatinine of 0.05 mmol/L or greater in the first 72 hours after cardiac surgery.

Secondary

MeasureTime frame
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.

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026