N-acetylcysteine as a Preventive Measure for Contrast Induced Nephropathy in Intensive Care Patients with Renal Insufficiency

ISRCTN	ISRCTN43635237
DOI	https://doi.org/10.1186/ISRCTN43635237
Protocol serial number	N/A
Sponsor	Academic Medical Centre (AMC) (Netherlands)
Funder	Academic Medical Center (AMC) (The Netherlands) - Department of Intensive Care

Submission date: 20/12/2005
Registration date: 20/12/2005
Last edited: 19/10/2007

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

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr M J Schultz
Scientific

Department of Intensive Care
Academic Medical Centre
University of Amsterdam
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Email	m.j.schultz@amc.uva.nl

Study information

Primary study design	Interventional
Study design	Multicentre, randomised, double blind, placebo controlled, parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	NACCINIC-trial
Study objectives	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(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	N-acetylcysteine
Primary outcome measure(s)	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
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	01/01/2008

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	246
Key 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
Key exclusion criteria	1. Pregnancy 2. No informed consent
Date of first enrolment	01/01/2006
Date of final enrolment	01/01/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

Department of Intensive Care

Amsterdam
1105 AZ
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan