Text Size

The Effect of Isoflurane or Sevoflurane on Kidney Function

This study has been terminated.
Sponsor:
Information provided by:
Austin Health
ClinicalTrials.gov Identifier:
NCT00144118
First received: September 2, 2005
Last updated: NA
Last verified: August 2005
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Kidney Failure
 Drug: sevoflurane or isoflurane
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Post-Operative Creatinine Changes In Patients With Pre-Existing Renal Impairment After Low-Flow Isoflurane Or Sevoflurane: A Randomised Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Austin Health:

Primary Outcome Measures:
  • Change in creatinine in first three postoperative days

Estimated Enrollment: 270
Study Start Date: January 2002
Estimated Study Completion Date: August 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00144118

Locations
Australia, Victoria
Department of Anaesthesia, Austin Health
Melbourne, Victoria, Australia, 3084
Sponsors and Collaborators
Austin Health
Investigators
Principal Investigator: David A Story, MD Department of Anaesthesia, Austin Health
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00144118     History of Changes
Other Study ID Numbers: H2000/01072
Study First Received: September 2, 2005
Last Updated: September 2, 2005
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Isoflurane
Sevoflurane
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Platelet Aggregation Inhibitors
Hematologic Agents

ClinicalTrials.gov processed this record on June 17, 2013