Trial record 1 of 89 for:
Open Studies | "Ascorbic Acid"
Efficacy of Ascorbic Acid for Prevention of Colistin-Associated Nephrotoxicity
This study is not yet open for participant recruitment.
Verified December 2011 by Mahidol University
Sponsor:
Mahidol University
Collaborator:
Siriraj Hospital
Information provided by (Responsible Party):
Mahidol University
ClinicalTrials.gov Identifier:
NCT01501968
First received: December 24, 2011
Last updated: December 29, 2011
Last verified: December 2011
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Purpose
Ascorbic acid (Vitamin C) could protect renal toxicity from colistin.
| Condition | Intervention | Phase |
|---|---|---|
|
Drug Safety |
Drug: Colistin Drug: Colistin + Ascorbic acid |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Efficacy of Ascorbic Acid for Prevention of Colistin-Associated Nephrotoxicity |
Resource links provided by NLM:
MedlinePlus related topics:
Vitamin C
Drug Information available for:
Ascorbic acid
Sodium ascorbate
Colistin
Colistin sulfate
Colistimethate sodium
Colistimethate
U.S. FDA Resources
Further study details as provided by Mahidol University:
Primary Outcome Measures:
- number of patients with Renal toxicity associated with colistin [ Time Frame: up to 28 days ] [ Designated as safety issue: Yes ]Renal toxicity associated with colistin according to RIFLE criteria
Secondary Outcome Measures:
- number of subjects with cure or improvement [ Time Frame: up to 28 days ] [ Designated as safety issue: Yes ]cure improvement worse death
| Estimated Enrollment: | 54 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Colistin
Colistimethate sodium 2.5-5mg/kg iv
|
Drug: Colistin
Colistimethate sodium 2.5-5mg/kg iv per day
Other Name: Colistate
|
|
Experimental: Colistin + Ascorbic acid
Colistimethate sodium 2.5-5mg/kg iv and ascorbic acid 2 grams iv every 12 hours
|
Drug: Colistin + Ascorbic acid
Colistimethate sodium 2.5-5mg/kg iv per day and ascorbic acid 2 grams iv q 12 hours
Other Name: vitamin c
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01501968
Contacts
| Contact: Visanu Thamlikitkul, MD | 662-419-7783 | sivth@mahidol.ac.th |
Locations
| Thailand | |
| Siriraj Hospital | Not yet recruiting |
| Bangkok, Thailand, 10700 | |
| Contact: Visanu Thamlikitkul, MD 662-4197783 sivth@mahidol.ac.th | |
| Principal Investigator: Visanu Thamlikitkul, MD | |
Sponsors and Collaborators
Mahidol University
Siriraj Hospital
Investigators
| Principal Investigator: | Visanu Thamlikitkul, MD | Faculty of Medicine Siriraj Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | Mahidol University |
| ClinicalTrials.gov Identifier: | NCT01501968 History of Changes |
| Other Study ID Numbers: | CEU 2012-01 |
| Study First Received: | December 24, 2011 |
| Last Updated: | December 29, 2011 |
| Health Authority: | Thailand: Ethical Committee |
Keywords provided by Mahidol University:
|
Colistin ascorbic acid renal toxicity |
Additional relevant MeSH terms:
|
Ascorbic Acid Colistin Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs |
Vitamins Micronutrients Growth Substances Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013