search
Back to results

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

Primary Purpose

Renal Impairment After Cardiac Surgery

Status
Withdrawn
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Frusemide
Sponsored by
Melbourne Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Renal Impairment After Cardiac Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: Already in established dialysis dependent chronic renal failure. Known allergy to frusemide Age < 18 years Pregnant

Sites / Locations

  • Intensive Care Unit, Royal Melbourne Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Standard Care

Intervention

Arm Description

Patients will only receive frusemide as per the treating physicians treatment

Patients will be given frusemide to achieve a study specified urine output target of 1-2mls/kg/hour

Outcomes

Primary Outcome Measures

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. 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.

Full Information

First Posted
October 27, 2005
Last Updated
April 23, 2015
Sponsor
Melbourne Health
search

1. Study Identification

Unique Protocol Identification Number
NCT00246675
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Withdrawn
Why Stopped
The study has ceased recruiting as Ethics approval has lapsed and the investigator availability reduced.
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Melbourne Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Impairment After Cardiac Surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Care
Arm Type
Other
Arm Description
Patients will only receive frusemide as per the treating physicians treatment
Arm Title
Intervention
Arm Type
Other
Arm Description
Patients will be given frusemide to achieve a study specified urine output target of 1-2mls/kg/hour
Intervention Type
Drug
Intervention Name(s)
Frusemide
Primary Outcome Measure Information:
Title
The incidence of increase in creatinine of 0.05 mmol/L or greater in the first 72 hours after cardiac surgery.
Secondary Outcome Measure Information:
Title
1. The maximum change in serum creatinine from baseline value during the first 7 days of hospital stay.
Title
2. Incidence of renal failure requiring any form of renal replacement therapy.
Title
3. Duration of post-operative hospital and ICU stay.
Title
4. The maximum Sequential Organ Failure Assessment (SOFA) score in the first 7 days of hospital stay.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: Already in established dialysis dependent chronic renal failure. Known allergy to frusemide Age < 18 years Pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John F Cade
Organizational Affiliation
Royal Melbourne Hospital, Intensive Care Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Intensive Care Unit, Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs