Condition category
Urological and Genital Diseases
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
19/10/2007
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

Dr M J Schultz

ORCID ID

Contact details

Department of Intensive Care
Academic Medical Centre
University of Amsterdam
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
m.j.schultz@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

NACCINIC-trial

Study hypothesis

On the assumption that N-acetylcysteine might prevent acute contrast induced nephropathy in critically ill patients, we study the effects of prophylactic intravenous administration of N-acetylcysteine in critically ill patients with renal insufficiency.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Multicentre, randomised, double blind, placebo controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Renal insufficiency

Intervention

Patients are randomly assigned to receive either N-acetylcysteine before and after administration of the contrast agent (acetylcysteine group) or placebo at the same time points (control group).

N-acetylcysteine or placebo is given intravenously in a double blinded fashion. N-acetylcysteine is given at a dose of 5000 mg on the day before and on the day of administration of the contrast agent, for a total of two days.

Intervention type

Drug

Phase

Not Specified

Drug names

N-acetylcysteine

Primary outcome measures

1. Rise in plasma creatinine greater than 25% within 48 hours after contrast administration
2. Need for Continuous Venous-Venous Haemofiltration (CVVH) therapy at any moment during stay in ICU
3. Duration of CVVH therapy, if initiated
4. Renal insufficiency (for which ongoing renal replacement therapy) at ICU-discharge

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/01/2006

Overall trial end date

01/01/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. (Chronic or acute) renal insufficiency (not presently on renal replacement therapy) defined as a plasma creatinine greater than 180 µmol/L
2. Planned diagnostic imaging procedure requiring the use of intravenous radiographic contrast agents
3. Admitted to one of the participating intensive care units

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

246

Participant exclusion criteria

1. Pregnancy
2. No informed consent

Recruitment start date

01/01/2006

Recruitment end date

01/01/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Department of Intensive Care
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (Netherlands)

Sponsor details

Department of Obstetrics and Gynaecology
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.amc.uva.nl/

Funders

Funder type

Hospital/treatment centre

Funder name

Academic Medical Center (AMC) (The Netherlands) - Department of Intensive Care

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