NCT00246675

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 31, 2005

Completed
Last Updated

April 27, 2015

Status Verified

April 1, 2015

First QC Date

October 27, 2005

Last Update Submit

April 23, 2015

Conditions

Renal Impairment After Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

  • 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.

Study Arms (2)

Standard Care

OTHER

Patients will only receive frusemide as per the treating physicians treatment

Drug: Frusemide

Intervention

OTHER

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

Drug: Frusemide

Interventions

FrusemideDRUG
InterventionStandard Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intensive Care Unit, Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

MeSH Terms

Interventions

Furosemide

Intervention Hierarchy (Ancestors)

SulfanilamidesSulfonamidesAmidesOrganic ChemicalsAniline CompoundsAminesSulfonesSulfur Compounds

Study Officials

  • John F Cade

    Royal Melbourne Hospital, Intensive Care Unit

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 27, 2005

First Posted

October 31, 2005

Last Updated

April 27, 2015

Record last verified: 2015-04

Locations

AU(1)