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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

Page last updated: August 20, 2015

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