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Efficacy of Ascorbic Acid for Prevention of Colistin-Associated Nephrotoxicity

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 December 2011 by Mahidol University.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01501968
First Posted: December 30, 2011
Last Update Posted: December 30, 2011
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.
Collaborator:
Siriraj Hospital
Information provided by (Responsible Party):
Mahidol University
  Purpose
Ascorbic acid (Vitamin C) could protect renal toxicity from colistin.

Condition Intervention Phase
Drug Safety Drug: Colistin Drug: Colistin + Ascorbic acid Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Efficacy of Ascorbic Acid for Prevention of Colistin-Associated Nephrotoxicity

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • number of patients with Renal toxicity associated with colistin [ Time Frame: up to 28 days ]
    Renal toxicity associated with colistin according to RIFLE criteria


Secondary Outcome Measures:
  • number of subjects with cure or improvement [ Time Frame: up to 28 days ]
    cure improvement worse death


Estimated Enrollment: 54
Study Start Date: January 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Colistin
Colistimethate sodium 2.5-5mg/kg iv
Drug: Colistin
Colistimethate sodium 2.5-5mg/kg iv per day
Other Name: Colistate
Experimental: Colistin + Ascorbic acid
Colistimethate sodium 2.5-5mg/kg iv and ascorbic acid 2 grams iv every 12 hours
Drug: Colistin + Ascorbic acid
Colistimethate sodium 2.5-5mg/kg iv per day and ascorbic acid 2 grams iv q 12 hours
Other Name: vitamin c

Detailed Description:
Renal toxicity due to colistin therapy is common. Ascorbic acid (vitamin C) has been shown to prevent colistin associated renal toxicity in animals. This study is conducted to determine if acorbic acid can prevent Colistin-Associated Nephrotoxicity.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age > 18 years hospitalized patient who needs colistin for therapy of nosocomial infection

Exclusion Criteria:

  • pregnant woman
  • lactating mother
  • allergy to ascorbic acid
  • receiving non-steroidal antiinflammatory drugs (NSAID), aminoglycosides, vancomycin, cisplatin, amphotericin-B
  • received radiocontrast media within 1 week
  • renal stone
  • G-6-PD deficiency
  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): NCT01501968


Contacts
Contact: Visanu Thamlikitkul, MD 662-419-7783 sivth@mahidol.ac.th

Locations
Thailand
Siriraj Hospital Not yet recruiting
Bangkok, Thailand, 10700
Contact: Visanu Thamlikitkul, MD    662-4197783    sivth@mahidol.ac.th   
Principal Investigator: Visanu Thamlikitkul, MD         
Sponsors and Collaborators
Mahidol University
Siriraj Hospital
Investigators
Principal Investigator: Visanu Thamlikitkul, MD Faculty of Medicine Siriraj Hospital
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01501968     History of Changes
Other Study ID Numbers: CEU 2012-01
First Submitted: December 24, 2011
First Posted: December 30, 2011
Last Update Posted: December 30, 2011
Last Verified: December 2011

Keywords provided by Mahidol University:
Colistin
ascorbic acid
renal toxicity

Additional relevant MeSH terms:
Ascorbic Acid
Colistin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances
Anti-Bacterial Agents
Anti-Infective Agents