Efficacy of Ascorbic Acid for Prevention of Colistin-Associated Nephrotoxicity

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Mahidol University.
Recruitment status was  Not yet recruiting
Sponsor:
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Colistin
Ascorbic Acid
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on October 01, 2014