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Contrast Agent-associated Nephrotoxicity in Intensive Care Unit Patients (ICU)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2009 by University of Thessaly.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01017796
First Posted: November 23, 2009
Last Update Posted: November 23, 2009
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:
University of Thessaly
  Purpose
The use of N-acetylcysteine and ascorbic acid reduce the incidence of radiographic contrast agent induced reduction in renal function in Intensive Care Unit patients.

Condition Intervention Phase
Contrast Induced Nephropathy Drug: N-acetylcysteine and ascorbic acid Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Acetylcysteine and Ascorbic Acid on the Prevention of Radiographic-contrast-agent Induced Reduction in Renal Function in ICU Patients.

Resource links provided by NLM:


Further study details as provided by University of Thessaly:

Primary Outcome Measures:
  • Morbidity in the Intensive Care Unit [ Time Frame: 1,5 year ]

Secondary Outcome Measures:
  • Incidence of acute nephropathy after administration of radiocontrast agents [ Time Frame: 1,5 year ]

Estimated Enrollment: 100
Study Start Date: January 2009
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A. Experimental
1200mg acetylcysteine and 2g ascorbic acid at least 2 hours before the start of the index procedure, followed by 1200mg acetylcysteine and 1,5g ascorbic acid the night and the morning after the examination.
Drug: N-acetylcysteine and ascorbic acid
1200mg acetylcysteine and 2g ascorbic acid in 200 ml 0,9% normal saline at least 2 hours before the start of the index procedure, followed by 1200mg acetylcysteine and 1,5g ascorbic acid the night and the morning after the examination.
Placebo Comparator: B. Control
200ml 0,9% normal saline IV
Drug: N-acetylcysteine and ascorbic acid
1200mg acetylcysteine and 2g ascorbic acid in 200 ml 0,9% normal saline at least 2 hours before the start of the index procedure, followed by 1200mg acetylcysteine and 1,5g ascorbic acid the night and the morning after the examination.

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  Eligibility

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Presence in the Intensive Care Unit
  • Patients undergoing radiologic examinations with the use of IV contrast agents.

Exclusion Criteria:

  • Renal failure under renal replacement therapy
  • Unstable renal function ( change of serum creatinine between two subsequent days greater than 20% at least 3 days before the study)
  • IV administration of contrast agent within the previous 6 days from the study
  • Use of ascorbic acid or acetylcysteine during the week before the study
  • Pregnancy
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Zakynthinos E, Intensive Care Unit department University Hospital Larisa.
ClinicalTrials.gov Identifier: NCT01017796     History of Changes
Other Study ID Numbers: KN19201
KIMNEF681264
KIMNEF681264 ( Other Grant/Funding Number: UThessaly )
First Submitted: November 20, 2009
First Posted: November 23, 2009
Last Update Posted: November 23, 2009
Last Verified: November 2009

Keywords provided by University of Thessaly:
Contrast induced nephropathy

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases
Acetylcysteine
N-monoacetylcystine
Ascorbic Acid
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
Vitamins
Micronutrients
Growth Substances