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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by University of Thessaly.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Thessaly
ClinicalTrials.gov Identifier:
NCT01017796
First received: November 20, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  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
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: Yes ]

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

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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
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
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.

No Contacts or Locations Provided
  More Information

No publications provided

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
Study First Received: November 20, 2009
Last Updated: November 20, 2009
Health Authority: Greece: Ethics Committee

Keywords provided by University of Thessaly:
Contrast induced nephropathy

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases
Acetylcysteine
N-monoacetylcystine
Ascorbic Acid
Contrast Media
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes
Vitamins
Micronutrients
Growth Substances
Diagnostic Uses of Chemicals

ClinicalTrials.gov processed this record on July 31, 2014