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| Sponsored by: |
Technische Universität München |
|---|---|
| Information provided by: | Technische Universität München |
| ClinicalTrials.gov Identifier: | NCT00492518 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Contrast Induced Nephropathy Kidney Diseases Renal Failure Adverse Effects |
Drug: Acetylcysteine Drug: Theophylline Drug: Placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Acetylcysteine, Theophylline, and a Combination of Both in the Prophylaxis of Contrast-Induced Nephropathy: A Placebo Controlled Randomized Study |
| Enrollment: | 254 |
| Study Start Date: | February 2002 |
| Study Completion Date: | October 2004 |
Contrast-induced nephropathy (CIN) is the third leading cause of hospital-acquired acute renal failure (ARF). Accounting for 12% of ARF cases, CIN is defined as an increase of serum creatinine of at least 0.5 mg/d (“Barrett´s definition”) and/or 25% within 48 hours of contrast-medium application. CIN is associated with prolonged hospitalisation and increased mortality. CIN frequency depends on several risk-factors including pre-existing renal dysfunction, high amounts of contrast-medium, diabetes, and concurrent use of nephrotoxic drugs. CIN incidence is low in the absence of risk-factors; however, in high-risk patients, CIN occurs in more than 50% of patients. A variety of prophylactic approaches have been investigated. Despite nephro-protective effects of hydration with saline or with sodium bicarbonate, other trials reported CIN-incidences between 20 and 50% despite hydration. Several studies and two recent meta-analyses demonstrated a significant reduction of renal impairment after contrast-medium using medical prophylaxis with the adenosine antagonist theophylline. However, a recent trial failed to prove prophylactic effects of theophylline. The antioxidant acetylcysteine (ACC) was effective in patients with impaired renal function in at least six studies, but it was not preventive in at least 21 trials and two recent meta-analyses. A recent study comparing the prophylactic efficacy of theophylline and acetylcysteine demonstrated superior prophylactic effects of theophylline. Nevertheless, this study did not include a placebo group, was not restricted to patients with impaired renal function and exclusively enrolled ICU-patients. Therefore, we performed a double-blinded study to compare the effects of acetylcysteine, theophylline, a combination of both, and placebo in patients with impaired renal function (serum creatinine >=1.3mg/dl) parenterally receiving >=100ml of contrast-medium.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Germany | |
| Klinikum Rechts der Isar; Technical University of Munich | |
| Munich, Germany, D-81675 | |
| Principal Investigator: | Wolfgang Huber, MD | Technische Universität München |
More Information
| Study ID Numbers: | ACC-Theo-1.3 |
| Study First Received: | June 26, 2007 |
| Last Updated: | June 26, 2007 |
| ClinicalTrials.gov Identifier: | NCT00492518 History of Changes |
| Health Authority: | Germany: Ethics Commission |
|
Contrast Induced Nephropathy Prophylaxis Theophylline Acetylcysteine Coronary angiography |
|
Vasodilator Agents Renal Insufficiency Antioxidants Anti-Asthmatic Agents Cardiovascular Agents Antiviral Agents Phosphodiesterase Inhibitors Urologic Diseases |
Expectorants Acetylcysteine Kidney Diseases Peripheral Nervous System Agents Bronchodilator Agents N-monoacetylcystine Kidney Failure Theophylline |
|
Respiratory System Agents Anti-Infective Agents Vasodilator Agents Renal Insufficiency Antioxidants Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Urologic Diseases Therapeutic Uses Free Radical Scavengers Acetylcysteine Kidney Diseases Antidotes Anti-Asthmatic Agents |
Enzyme Inhibitors Cardiovascular Agents Antiviral Agents Protective Agents Pharmacologic Actions Phosphodiesterase Inhibitors Autonomic Agents Expectorants Peripheral Nervous System Agents Bronchodilator Agents N-monoacetylcystine Theophylline Kidney Failure |