NCT00144118

Brief Summary

The purpose of this study is to determine if isoflurane and sevoflurane have similar effects on the kidneys of people with impaired kidneys when the drugs administered with low gas flow into anaesthetic machines.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
270

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2002

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

January 1, 2002

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed
Last Updated

September 5, 2005

Status Verified

August 1, 2005

First QC Date

September 2, 2005

Last Update Submit

September 2, 2005

Conditions

Kidney Failure

Outcome Measures

Primary Outcomes (1)

  • Change in creatinine in first three postoperative days

Interventions

sevoflurane or isofluraneDRUG

Eligibility Criteria

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

You may qualify if:

  • Adult patients for elective surgery who will:
  • Need to stay at least one night, and
  • Need general anaesthesia, and
  • Have a pre-operative serum creatinine concentration greater than 130 umol/l.

You may not qualify if:

  • The patient refuses.
  • The patient is less than 18 years of age.
  • The patient is on pre-operative dialysis
  • The anaesthetist plans to use only regional or total intravenous anaesthesia.
  • Specific types of surgery: craniotomy, carotid, and cardiac.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaesthesia, Austin Health

Melbourne, Victoria, 3084, Australia

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

SevofluraneIsoflurane

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbons

Study Officials

  • David A Story, MD

    Department of Anaesthesia, Austin Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 5, 2005

Study Start

January 1, 2002

Study Completion

August 1, 2005

Last Updated

September 5, 2005

Record last verified: 2005-08

Locations

AU(1)