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

ISRCTN	ISRCTN94244587
DOI	https://doi.org/10.1186/ISRCTN94244587
Protocol serial number	DFG ME 1257/3-2
Sponsor	German Research Foundation (DFG) (Germany)
Funder	German Research Foundation (DFG)

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

Primary study design	Interventional
Study design	Randomised, double-blind, placebo-controlled clinical trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	N-acetylcysteine
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	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
Completion date	31/12/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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.