Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12606000088549
Ethics application status
Approved
Date submitted
25/02/2006
Date registered
1/03/2006
Date last updated
1/03/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Preoperative intranenous N-Acetylcysteine for the prevention of renal failure in patients with renal impairment undergoing cardiac surgery
Scientific title
Preoperative intranenous N-Acetylcysteine for the prevention of renal failure in patients with renal impairment undergoing cardiac surgery
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Impairment in cardiac surgery 1052 0
Condition category
Condition code
Renal and Urogenital 1132 1132 0 0
Other renal and urogenital disorders
Cardiovascular 1133 1133 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients who fit into Inclusion criteria will be randomised to receive intravenous N-Acetylcestine 150mg/kg for 16 hours.
Intervention code [1] 918 0
Prevention
Comparator / control treatment
Patients who fit into Inclusion criteria will be randomised to receive intravenous Placebo the day before surgery.
Control group
Placebo

Outcomes
Primary outcome [1] 1518 0
Occurrence of acute renal failure as defined by an increase in serum creatinine of greater than or equal to 44umol/L over the baseline value or an increase in creatinine of greater than 50% above baseline or a reduction in calculated creatinine clearance of 50%.
Timepoint [1] 1518 0
Measured on days 1, 3 and 5.
Secondary outcome [1] 2741 0
Peak serum creatinine level
Timepoint [1] 2741 0
Within 5 days
Secondary outcome [2] 2742 0
Creatinine clearance
Timepoint [2] 2742 0
Day 1, 3 and 5
Secondary outcome [3] 2743 0
Cystatin C levels
Timepoint [3] 2743 0
Pre-op, day 1, 3 & 5
Secondary outcome [4] 2744 0
Requirement for dialysis in hospital
Timepoint [4] 2744 0
Secondary outcome [5] 2745 0
Length of ICU stay
Timepoint [5] 2745 0
Secondary outcome [6] 2746 0
Length of hospital stay
Timepoint [6] 2746 0
Secondary outcome [7] 2747 0
In hospital mortality rate.
Timepoint [7] 2747 0

Eligibility
Key inclusion criteria
1. Patients with chronic stable renal impairment as evidenced by a creatinine >133µmol//L or creatinine clearance < 50ml/min as estimated by the Cockcroft- Gault formula20. ( Creatinine clearance or CrCl will be calculated by applying the Cockcroft- Gault formula to the baseline serum creatinine level: (140 – age) x weight/ serum creatinine x 0.815; with a female adjustment: CrCl female = CrCl x 0.85)2. Patients undergoing cardiac surgery requiring cardiopulmonary bypass including but not exclusive to coronary artery bypass grafting (CABG), valve surgery, combination CABG and valve replacement procedures, adult patients undergoing surgery for congenital heart disease, repairs of ventricular aneurysm, septal defect repairs and removal of myxomas, stable patients with intraaortic balloon pump (IABP) inserted electively preoperatively, redo cases requiring cardiopulmonary bypass (CPB). 3. Patients who have given consent.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Females of child bearing age in whom pregnancy has not been disproved, are pregnant or lactating. 2. Haemodynamically unstable patients with SBP< 90mmHg preoperatively. 3. Patients with acute renal failure. 4. Patients receiving haemodialysis or peritoneal dialysis. 5. Treatment with nonsteroidal anti-inflammatory agents (NSAIDs) within previous 4 days. 6. Patients allergic to acetylcysteine. 7. Patients with current acute exacerbations of asthma or chronic obstructive pulmonary disease. 8. Impaired liver function. 9. Renal transplant patients.10. Failure to consent.

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



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1234 0
Charities/Societies/Foundations
Name [1] 1234 0
Intensive care research fund
Country [1] 1234 0
Primary sponsor type
Hospital
Name
Prince of Wales Hospital
Address
Country
Australia
Secondary sponsor category [1] 1091 0
None
Name [1] 1091 0
Nil
Address [1] 1091 0
Country [1] 1091 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2563 0
Prince of Wales ethics
Ethics committee address [1] 2563 0
Ethics committee country [1] 2563 0
Australia
Date submitted for ethics approval [1] 2563 0
Approval date [1] 2563 0
22/07/2003
Ethics approval number [1] 2563 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35687 0
Address 35687 0
Country 35687 0
Phone 35687 0
Fax 35687 0
Email 35687 0
Contact person for public queries
Name 10107 0
Naomi Hammond
Address 10107 0
Intensive Care Unit
Prince of Wales Hospital
Level 1
Dickinson Building
Barker St
Randwick NSW 2031
Country 10107 0
Australia
Phone 10107 0
+61 2 93824720
Fax 10107 0
+61 2 93824748
Email 10107 0
[email protected]
Contact person for scientific queries
Name 1035 0
Dr Yahya Shehabi
Address 1035 0
Intensive Care Unit
Prince of Wales Hospital
Level 1
Dickinson Building
Barker St
Randwick NSW 2031
Country 1035 0
Australia
Phone 1035 0
+61 2 93824721
Fax 1035 0
+61 2 93824870
Email 1035 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.