Drug Safety
Conditions
Keywords
Colistin, ascorbic acid, renal toxicity
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.
Interventions
DRUGColistin
Colistimethate sodium 2.5-5mg/kg iv per day
DRUGColistin + Ascorbic acid
Colistimethate sodium 2.5-5mg/kg iv per day and ascorbic acid 2 grams iv q 12 hours
Sponsors
Siriraj Hospital
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of patients with Renal toxicity associated with colistin | up to 28 days | Renal toxicity associated with colistin according to RIFLE criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of subjects with cure or improvement | up to 28 days | cure improvement worse death |
Countries
Thailand
Contacts
Primary ContactVisanu Thamlikitkul, MD
Outcome results
None listed