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

NCT00492518 | Completed Phase 4 DMC

• 1 other identifier: ACC-Theo-1.3
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Contrast Induced Nephropathy; Kidney Diseases; Renal Failure; Adverse Effects

Keywords

Contrast Induced Nephropathy; Prophylaxis; Theophylline; Acetylcysteine; Coronary angiography

Outcome Measures

Primary Outcomes (1)

• The incidence of contrast induced nephropathy, defined as an increase of serum creatinine of at least 0.5 mg/d and/or 25% within 48 hours of contrast-medium application (comparison of treatment groups to placebo)

  48h after the application of contrast-medium

Secondary Outcomes (1)

• Change in serum creatinine 48h after contrast medium compared to pre-contrast serum creatinine. Multiple regression analysis of risk-factors of CIN with "Y=Maximum increase of serum creatinine compared to baseline within 48h"

  48h

Interventions

Acetylcysteine DRUG

Theophylline DRUG

Placebo DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Impaired renal function (serum creatinine \>=1.3mg/dl)
• \>=100ml of contrast-medium
• Age \>= 18years
• Informed consent

You may not qualify if:

• 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).

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

Klinikum Rechts der Isar; Technical University of Munich

Munich, D-81675, Germany

Location

MeSH Terms

Conditions

Kidney Diseases; Renal Insufficiency

Interventions

Acetylcysteine; Theophylline

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Wolfgang Huber, MD

  Technical University of Munich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 26, 2007
• First Posted: June 27, 2007
• Study Start: February 1, 2002
• Study Completion: October 1, 2004
• Last Updated: June 27, 2007

Record last verified: 2007-06

Locations

DE (1)