|- candidate number||1256|
|- NTR Number||NTR152|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||27-aug-2005|
|- Secondary IDs||N/A |
|- Public Title||N-acetylcysteine as a Preventive Measure for Contrast Induced Nephropathy in Intensive Care Patients with Renal Insufficiency.|
|- Scientific Title||N-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.|
|- 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.|
|- Healt Condition(s) or Problem(s) studied||Renal insufficiency|
|- Inclusion criteria||1. (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 criteria||1. Pregnancy;
2. No informed consent.
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||1-jan-2006|
|- planned closingdate||1-jan-2008|
|- Target number of participants||246|
|- Interventions||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.
|- Primary outcome||1. 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 outcome||N/A|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. M.J. Schultz|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. M.J. Schultz|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Department of Intensive Care|
(Source(s) of Monetary or Material Support)
|[default], Academic Medical Center (AMC), Department of Intensive Care|
|- Publications||Will be written after completion of study and anlysis of results|
|- Brief summary||Since 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)|
|- RECORD||20-aug-2005 - 15-dec-2010|