Condition category
Urological and Genital Diseases
Date applied
01/08/2006
Date assigned
29/08/2006
Last edited
29/08/2006
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dfg.de

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

Publication citations

Additional files

Editorial Notes