|
Main
|
|
Note: This record shows only the 20 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:
|
17 October 2012 |
|
Main ID: |
NCT00910221 |
|
Date of registration:
|
28/05/2009 |
|
Primary sponsor: |
|
|
Public title:
|
Cardiopulmonary-bypass and Reno-protective Effect of Atorvastatin Trial
CREAT |
|
Scientific title:
|
A Phase II Randomised, Double-blind, Placebo-controlled Study of the Effect of Atorvastatin on Postoperative Renal Function in Patients Undergoing Elective Cardiopulmonary Bypass. |
|
Date of first enrolment:
|
March 2008 |
|
Target sample size:
|
100 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00910221 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
Australia
| | | | | | | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Cardiac surgical patients in whom the use of cardiopulmonary bypass was planned
- Written informed consent of patient
- Age > 18 years
- And having at least one ore more of the following risk factors for postoperative AKI:
- Age =/> 70 years
- Preoperative plasma creatinine >120 µmol/L, New York Heart Association class
III/IV or LVEF <35%
- Insulin dependent diabetes mellitus
- Valve surgery (with or without coronary artery bypass graft)
- Redo cardiac surgery
Exclusion Criteria:
- An emergency operation is indicated (within 24 hours after hospital admission or on
intra-aortic balloon pump)
- Pregnancy is confirmed or breastfeeding is present
- A renal allograft is present
- Preoperative acute renal failure within 6 weeks (acute rise in serum creatinine > 50%
from baseline) is present
- Pre-operative end stage renal disease (serum creatinine > 300 µmol/L) is present
- Chronic moderate to high dose corticosteroid therapy (>10 mg/d prednisone or
equivalent) is present
- Known Allergy to Atorvastatin
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Acute Kidney Dysfunction
|
|
Intervention(s)
|
|
Drug: Atorvastatin
|
|
Drug: Placebo
|
|
Primary Outcome(s)
|
|
Change in serum creatinine from baseline to peak level
[Time Frame: within first two-seven postoperative days]
|
|
Secondary Outcome(s)
|
|
Change in NGAL from baseline to peak
[Time Frame: within first 24 postoperatively]
|
|
Hospital-Mortality
[Time Frame: during hospital stay]
|
|
Length of stay in Hospital
[Time Frame: from admission to discharge from hospital]
|
|
Length of stay in Intensive care
[Time Frame: from admission to discharge from Intensive care]
|
|
Proportion of patients developing an increase in serum creatinine > 25% or >44µmicromol/L from baseline to peak level
[Time Frame: within first two-seven postoperative days]
|
|
Proportion of patients developing any of the AKI stages: 1, 2 or 3 (using network definition)
[Time Frame: within first seven postoperative days]
|
|
Proportion of patients developing any of the RIFLE criteria: R, I or F
[Time Frame: within first seven postoperative days]
|
|
Requirement of renal replacement therapy
[Time Frame: within hospital stay]
|
|
Secondary ID(s)
|
|
H2007/02810
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|