Renal protection by radical-scavenging with N-acetylcysteine in cardiac surgery patients

ISRCTN ISRCTN94244587
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

University of Cologne
Joseph-Stelzmann-Str. 9
Cologne
50924
Germany

Phone +49 (0) 221 478 6043
Email uwe.mehlhorn@uk-koeln.de

Study information

Study designRandomised, double-blind, placebo-controlled clinical trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleRenal protection by radical-scavenging with N-acetylcysteine in cardiac surgery patients
Study objectivesN-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) studiedRenal dysfunction induced by cardiopulmonary bypass (CPB) during cardiac surgery
InterventionNAC 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)N-acetylcysteine
Primary outcome measurePostoperative 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 measures1. 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 date01/01/2007
Completion date31/12/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants50
Total final enrolment40
Key inclusion criteria1. 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 criteria1. Pregnancy
2. Aged over 18 years
Date of first enrolment01/01/2007
Date of final enrolment31/12/2008

Locations

Countries of recruitment

  • Germany

Study participating centre

University of Cologne
Cologne
50924
Germany

Sponsor information

German Research Foundation (DFG) (Germany)
Research organisation

Kennedyallee 40
Bonn
53170
Germany

Phone +49 (0) 228 885 2239
Email gabriele.auster@dfg.de
Website http://www.dfg.de
ROR logo "ROR" https://ror.org/018mejw64

Funders

Funder type

Research organisation

German Research Foundation (DFG)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.