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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2012
Main ID:  NCT01017796
Date of registration: 20/11/2009
Primary sponsor: University of Thessaly
Public title: Contrast Agent-associated Nephrotoxicity in Intensive Care Unit Patients ICU
Scientific title: The Effect of Acetylcysteine and Ascorbic Acid on the Prevention of Radiographic-contrast-agent Induced Reduction in Renal Function in ICU Patients.
Date of first enrolment: January 2009
Target sample size: 100
Recruitment status: Active, not recruiting
URL:  http://clinicaltrials.gov/show/NCT01017796
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention  
Countries of recruitment
Contacts
Key inclusion & exclusion 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



Age minimum: 14 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Contrast Induced Nephropathy
Intervention(s)
Drug: N-acetylcysteine and ascorbic acid
Primary Outcome(s)
Morbidity in the Intensive Care Unit [Time Frame: 1,5 year]
Secondary Outcome(s)
Incidence of acute nephropathy after administration of radiocontrast agents [Time Frame: 1,5 year]
Secondary ID(s)
KIMNEF681264
KN19201
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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