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…
ID
Bron
Verkorte titel
Aandoening
Renal insufficiency (not yet requiring renal replacement therapy)
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Rise in plasma creatinine > 25% within 48 hours after contrast administration.<br>
Need for CVVH therapy at any moment during stay in ICU;<br>
2. Duration of CVVH therapy, if initiated;
<br>3. Renal insufficiency (for which ongoing renal replacement therapy) at ICU-discharge .
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksproduct en/of interventie
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.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. (Chronic or acute) renal insufficiency (not presently on renal replacement therapy) defined as a plasma creatinine > 180 ìmol/L;
2. Planned diagnostic imaging procedure requiring the use of intravenous radiographic contrast agents;
3. Admitted to one of the participating intensive care units.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Pregnancy;
2. No informed consent.
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL120 |
NTR-old | NTR152 |
Ander register | : N/A |
ISRCTN | ISRCTN43635237 |