Contact information
Type
Scientific
Primary contact
Prof Uwe Mehlhorn
ORCID ID
Contact details
University of Cologne
Joseph-Stelzmann-Str. 9
Cologne
50924
Germany
+49 (0) 221 478 6043
uwe.mehlhorn@uk-koeln.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
DFG ME 1257/3-2
Study information
Scientific title
Acronym
Study hypothesis
N-acetylcysteine (NAC) protects renal function in cardiac surgery patients subjected to Cardio-Pulmonary Bypass (CPB).
Ethics approval
The Institutional Ethics Committee of the Medical Faculty of the University of Cologne approved the study on 15th July 2005 (ref: #03-122).
Study design
Randomised, double-blind, placebo-controlled clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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 names
N-acetylcysteine
Primary outcome measures
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 trial start date
01/01/2007
Overall trial end date
31/12/2008
Reason abandoned
Eligibility
Participant 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%
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant exclusion criteria
1. Pregnancy
2. Aged over 18 years
Recruitment start date
01/01/2007
Recruitment end date
31/12/2008
Locations
Countries of recruitment
Germany
Trial participating centre
University of Cologne
Cologne
50924
Germany
Sponsor information
Organisation
German Research Foundation (DFG) (Germany)
Sponsor details
Kennedyallee 40
Bonn
53170
Germany
+49 (0) 228 885 2239
gabriele.auster@dfg.de
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
German Research Foundation (DFG)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary