|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT01384643 |
|
Date of registration:
|
27/06/2011 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Effect of Propofol on Renal Injury in Patients Undergoing Valvular Heart Surgery
|
|
Scientific title:
|
Effect of Propofol on Renal Injury in Patients Undergoing Valvular Heart Surgery: A Prospective, Randomized Controlled Trial |
|
Date of first enrolment:
|
May 2011 |
|
Target sample size:
|
112 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT01384643 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
Korea, Republic of
| | | | | | | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Patients undergoing valvular heart surgery.
- Age: 20~75.
Exclusion Criteria:
- Emergency operation.
- Patients with vitamin E or vitamin C within 5 days before surgery.
- Patients with preoperative C-reactive protein (CRP) > 16 mg/L.
- Patients with serum creatinine = 2.0 mg/dL
- Patients under hemodialysis.
- Patients with acute myocardial infarction within 1 week before surgery
Age minimum:
20 Years
Age maximum:
75 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Heart Valve Disease
|
|
Intervention(s)
|
|
Drug: Propofol
|
|
Primary Outcome(s)
|
|
Serum creatinine
[Time Frame: incidence of AKI during 48 hours after the surgery incidence of AKI]
|
|
Secondary ID(s)
|
|
1-2011-0007
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|