Efficacy of Ascorbic Acid for Prevention of Colistin-Associated Nephrotoxicity

Mahidol University

Status and phase: Unknown; Phase 3

Conditions: Drug Safety

Treatments: Drug: Colistin; Drug: Colistin + Ascorbic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT01501968

CEU 2012-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 54 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

Colistin

Active Comparator group

Description:

Colistimethate sodium 2.5-5mg/kg iv

Treatment:

Drug: Colistin

Colistin + Ascorbic acid

Experimental group

Description:

Colistimethate sodium 2.5-5mg/kg iv and ascorbic acid 2 grams iv every 12 hours

Treatment:

Drug: Colistin + Ascorbic acid