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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00492518
First Posted: June 27, 2007
Last Update Posted: June 27, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Technische Universität München
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Acetylcysteine, Theophylline, and a Combination of Both in the Prophylaxis of Contrast-Induced Nephropathy: A Placebo Controlled Randomized Study

Resource links provided by NLM:


Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • 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) [ Time Frame: 48h after the application of contrast-medium ]

Secondary Outcome Measures:
  • 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” [ Time Frame: 48h ]

Enrollment: 254
Study Start Date: February 2002
Study Completion Date: October 2004
Detailed Description:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00492518


Locations
Germany
Klinikum Rechts der Isar; Technical University of Munich
Munich, Germany, D-81675
Sponsors and Collaborators
Technische Universität München
Investigators
Principal Investigator: Wolfgang Huber, MD Technische Universität München
  More Information

ClinicalTrials.gov Identifier: NCT00492518     History of Changes
Other Study ID Numbers: ACC-Theo-1.3
First Submitted: June 26, 2007
First Posted: June 27, 2007
Last Update Posted: June 27, 2007
Last Verified: June 2007

Keywords provided by Technische Universität München:
Contrast Induced Nephropathy
Prophylaxis
Theophylline
Acetylcysteine
Coronary angiography

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency
Urologic Diseases
Acetylcysteine
N-monoacetylcystine
Theophylline
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Vasodilator Agents
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents


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