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

This study has been completed.
Sponsor:
Information provided by:
Technische Universität München
ClinicalTrials.gov Identifier:
NCT00492518
First received: June 26, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00492518     History of Changes
Other Study ID Numbers: ACC-Theo-1.3
Study First Received: June 26, 2007
Last Updated: June 26, 2007
Health Authority: Germany: Ethics Commission

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
Anti-Asthmatic Agents
Anti-Infective Agents
Antidotes
Antioxidants
Antiviral Agents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Enzyme Inhibitors
Expectorants
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Phosphodiesterase Inhibitors
Physiological Effects of Drugs
Protective Agents
Purinergic Agents
Purinergic Antagonists
Purinergic P1 Receptor Antagonists
Respiratory System Agents
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 21, 2014