Overview

Acetylcysteine, Theophylline, and a Combination of Both in the Prophylaxis of Contrast-Induced Nephropathy

Status:
Completed
Trial end date:
2004-10-01
Target enrollment:
0
Participant gender:
All
Summary
Several studies demonstrated a significant reduction of contrast-induced nephropathy (CIN; definition: increase in serum creatinine of >=0.5mg/dl and/or >=25% increase within 48h after contrast-medium) by acetylcysteine (A) or theophylline (T). However, the results are contradictory. Therefore, it was the aim of our double-blind study to compare the effects of A, T, a combination of A and T (A+T), and placebo (P).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Technische Universität München
Treatments:
Acetylcysteine
N-monoacetylcystine
Theophylline
Criteria
Inclusion Criteria:

- Impaired renal function (serum creatinine >=1.3mg/dl)

- >=100ml of contrast-medium

- Age >= 18years

- Informed consent

Exclusion Criteria:

- Previous dialysis and/or haemofiltration

- Pre-treatment with acetylcysteine and/or theophylline within the last 2 days,

- Pregnancy

- Contraindications to theophylline (untreated high grade arrhythmia or a history of
seizures) or acetylcysteine (known allergy).