Renal protection by radical-scavenging with N-acetylcysteine in cardiac surgery patients
ISRCTN | ISRCTN94244587 |
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DOI | https://doi.org/10.1186/ISRCTN94244587 |
Secondary identifying numbers | DFG ME 1257/3-2 |
- Submission date
- 01/08/2006
- Registration date
- 29/08/2006
- Last edited
- 07/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Uwe Mehlhorn
Scientific
Scientific
University of Cologne
Joseph-Stelzmann-Str. 9
Cologne
50924
Germany
Phone | +49 (0) 221 478 6043 |
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uwe.mehlhorn@uk-koeln.de |
Study information
Study design | Randomised, double-blind, placebo-controlled clinical trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | Renal protection by radical-scavenging with N-acetylcysteine in cardiac surgery patients |
Study objectives | N-acetylcysteine (NAC) protects renal function in cardiac surgery patients subjected to Cardio-Pulmonary Bypass (CPB). |
Ethics approval(s) | The Institutional Ethics Committee of the Medical Faculty of the University of Cologne approved the study on 15th July 2005 (ref: #03-122). |
Health condition(s) or problem(s) studied | Renal dysfunction induced by cardiopulmonary bypass (CPB) during cardiac surgery |
Intervention | NAC at 100 mg per kg of body weight into the CPB prime followed by NAC infusion at 20 mg per kg of bodyweight per hour until the end of CPB versus placebo (25 patients for each group). In addition to the standard blood analyses urine samples will be collected. There will be no other interventions, surgical and postoperative treatment will not differ from routine (non-study) patients. |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | N-acetylcysteine |
Primary outcome measure | Postoperative renal function assessed by means of the following variables in plasma and urine: 1. Creatinine concentration (primary variable) 2. Cystatin C concentration (co-primary variable) |
Secondary outcome measures | 1. Urea, retinol-binding protein, albumine, alpha1-microglobulin 2. Quantity of post-surgery diuretic medication, serum creatinine clearance 3. Oxidative stress variable in plasma and urine: 8-isoprostaglandinF2a |
Overall study start date | 01/01/2007 |
Completion date | 31/12/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 50 |
Total final enrolment | 40 |
Key inclusion criteria | 1. Male or female 2. No renal dysfunction requiring hemodialysis/hemofitration 3. Isolated coronary artery disease 4. Left ventricular ejection fraction more than 40% |
Key exclusion criteria | 1. Pregnancy 2. Aged over 18 years |
Date of first enrolment | 01/01/2007 |
Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- Germany
Study participating centre
University of Cologne
Cologne
50924
Germany
50924
Germany
Sponsor information
German Research Foundation (DFG) (Germany)
Research organisation
Research organisation
Kennedyallee 40
Bonn
53170
Germany
Phone | +49 (0) 228 885 2239 |
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gabriele.auster@dfg.de | |
Website | http://www.dfg.de |
https://ror.org/018mejw64 |
Funders
Funder type
Research organisation
German Research Foundation (DFG)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 01/08/2005 | 07/01/2021 | Yes | No |
Editorial Notes
07/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.