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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00144118




Registration number
NCT00144118
Ethics application status
Date submitted
2/09/2005
Date registered
5/09/2005
Date last updated
5/09/2005

Titles & IDs
Public title
The Effect of Isoflurane or Sevoflurane on Kidney Function
Scientific title
Post-Operative Creatinine Changes In Patients With Pre-Existing Renal Impairment After Low-Flow Isoflurane Or Sevoflurane: A Randomised Clinical Trial
Secondary ID [1] 0 0
H2000/01072
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney Failure 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - sevoflurane or isoflurane

Treatment: Drugs: sevoflurane or isoflurane
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in creatinine in first three postoperative days
Timepoint [1] 0 0

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Department of Anaesthesia, Austin Health - Melbourne
Recruitment postcode(s) [1] 0 0
3084 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Austin Health
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00144118
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David A Story, MD
Address 0 0
Department of Anaesthesia, Austin Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00144118