Efficacy of Ascorbic Acid for Prevention of Colistin-Associated Nephrotoxicity
Information source: Mahidol University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Drug Safety
Intervention: Colistin (Drug); Colistin + Ascorbic acid (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Mahidol University Official(s) and/or principal investigator(s): Visanu Thamlikitkul, MD, Principal Investigator, Affiliation: Faculty of Medicine Siriraj Hospital
Overall contact: Visanu Thamlikitkul, MD, Phone: 662-419-7783, Email: sivth@mahidol.ac.th
Summary
Ascorbic acid (Vitamin C) could protect renal toxicity from colistin.
Clinical Details
Official title: Efficacy of Ascorbic Acid for Prevention of Colistin-Associated Nephrotoxicity
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: number of patients with Renal toxicity associated with colistin
Secondary outcome: number of subjects with cure or improvement
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
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Visanu Thamlikitkul, MD, Phone: 662-419-7783, Email: sivth@mahidol.ac.th
Siriraj Hospital, Bangkok 10700, Thailand; Not yet recruiting Visanu Thamlikitkul, MD, Phone: 662-4197783, Email: sivth@mahidol.ac.th Visanu Thamlikitkul, MD, Principal Investigator
Additional Information
mahidol webpage
Starting date: January 2012
Last updated: December 29, 2011
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