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NCT01501968 Clinical Trial

Efficacy of Ascorbic Acid for Prevention of Colistin-Associated Nephrotoxicity

Drug Safety Clinical Trial

Official title:
Efficacy of Ascorbic Acid for Prevention of Colistin-Associated Nephrotoxicity

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01501968
Other study ID # CEU 2012-01
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received December 24, 2011
Last updated December 29, 2011
Start date January 2012
Est. completion date December 2013

Study information
Verified date December 2011
Source Mahidol University
Contact Visanu Thamlikitkul, MD
Phone 662-419-7783
Email sivth@mahidol.ac.th
Is FDA regulated No
Health authority Thailand: Ethical Committee
Study type Interventional

Clinical Trial Summary

Ascorbic acid (Vitamin C) could protect renal toxicity from colistin.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 54
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Colistin
Colistimethate sodium 2.5-5mg/kg iv per day
• Colistin + Ascorbic acid
Colistimethate sodium 2.5-5mg/kg iv per day and ascorbic acid 2 grams iv q 12 hours

Locations
Country Name City State
Thailand Siriraj Hospital Bangkok

Sponsors (2)
Lead Sponsor Collaborator
Mahidol University Siriraj Hospital

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary number of patients with Renal toxicity associated with colistin Renal toxicity associated with colistin according to RIFLE criteria up to 28 days Yes
Secondary number of subjects with cure or improvement cure improvement worse death up to 28 days Yes
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