Efficacy of Ascorbic Acid for Prevention of Colistin-Associated Nephrotoxicity

Phase 3UnknownNCT01501968

Mahidol University54 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Drug Safety

Interventions

ColistinDRUG

Colistimethate sodium 2.5-5mg/kg iv per day

Colistin + Ascorbic acidDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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 (1)

Siriraj Hospital

Bangkok, Bangkok, Thailand

Outcomes

Primary Outcomes

number of patients with Renal toxicity associated with colistin

Renal toxicity associated with colistin according to RIFLE criteria

Time frame: up to 28 days

Secondary Outcomes

number of subjects with cure or improvement

cure improvement worse death

Time frame: up to 28 days

Central Contacts

Visanu Thamlikitkul, MD

CONTACT

662-419-7783 sivth@mahidol.ac.th

Data from ClinicalTrials.gov

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