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Efficacy of Ascorbic Acid for Prevention of Colistin-Associated Nephrotoxicity

Phase 3
Conditions
Drug Safety
Interventions
Registration Number
NCT01501968
Lead Sponsor
Mahidol University
Brief Summary

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

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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
54
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

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Colistin + Ascorbic acidColistin + Ascorbic acidColistimethate sodium 2.5-5mg/kg iv and ascorbic acid 2 grams iv every 12 hours
ColistinColistinColistimethate sodium 2.5-5mg/kg iv
Primary Outcome Measures
NameTimeMethod
number of patients with Renal toxicity associated with colistinup to 28 days

Renal toxicity associated with colistin according to RIFLE criteria

Secondary Outcome Measures
NameTimeMethod
number of subjects with cure or improvementup to 28 days

cure improvement worse death

Trial Locations

Locations (1)

Siriraj Hospital

đŸ‡¹đŸ‡­

Bangkok, Thailand

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