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


- candidate number1256
- NTR NumberNTR152
- ISRCTNISRCTN43635237
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR27-aug-2005
- Secondary IDsN/A 
- Public TitleN-acetylcysteine as a Preventive Measure for Contrast Induced Nephropathy in Intensive Care Patients with Renal Insufficiency.
- Scientific TitleN-acetylcysteine as a Preventive Measure for Contrast Induced Nephropathy in Intensive Care Patients with Renal Insufficiency - a randomized double-blind placebo-controlled multicenter study in patients not on renal replacement therapy.
- ACRONYMNACCINIC-trial
- hypothesisOn 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.
- Healt Condition(s) or Problem(s) studiedRenal insufficiency
- Inclusion criteria1. (Chronic or acute) renal insufficiency (not presently on renal replacement therapy) defined as a plasma creatinine > 180 ýmol/L;
2. Planned diagnostic imaging procedure requiring the use of intravenous radiographic contrast agents;
3. Admitted to one of the participating intensive care units.
- Exclusion criteria1. Pregnancy;
2. No informed consent.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type[default]
- Studytypeintervention
- planned startdate 1-jan-2006
- planned closingdate1-jan-2008
- Target number of participants246
- InterventionsPatients 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.
- Primary outcome1. Rise in plasma creatinine > 25% within 48 hours after contrast administration.
Need for CVVH therapy at any moment during stay in ICU;
2. Duration of CVVH therapy, if initiated;
3. Renal insufficiency (for which ongoing renal replacement therapy) at ICU-discharge .
- Secondary outcomeN/A
- Timepoints
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. Dr. M.J. Schultz
- CONTACT for SCIENTIFIC QUERIESProf. Dr. M.J. Schultz
- Sponsor/Initiator Academic Medical Center (AMC), Department of Intensive Care
- Funding
(Source(s) of Monetary or Material Support)
[default], Academic Medical Center (AMC), Department of Intensive Care
- PublicationsWill be written after completion of study and anlysis of results
- Brief summarySince contrast-induced nephropathy accounts for a significant increase of hospital-acquired renal failure, several strategies to prevent contrast-induced nephropathy are presently advocated, including the use of alternative imaging techniques (for which contrast media are not needed), the use of (the lowest possible amount of) iso-osmolar or low-osmolar contrast agents (instead of high-osmolar contrast agents), hyperhydration and forced diuresis.
Administration of N-acetylcysteine, theophylline or fenoldopam, sodium bicarbonate infusion, and peri-procedural hemofiltration/hemodialysis have been investigated as preventive measures in recent years.
Unfortunately, results from the several trials are divers, some show a beneficial effect, and some show no effect of the intervention at all. It is uncertain whether contrast-induced nephropathy is an important entity in intensive care medicine.
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.
- Main changes (audit trail)
- RECORD20-aug-2005 - 15-dec-2010


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