Efficacy of Ascorbic Acid for Prevention of Colistin-Associated Nephrotoxicity

December 29, 2011 updated by: Mahidol University
Ascorbic acid (Vitamin C) could protect renal toxicity from colistin.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

54

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Siriraj Hospital
        • Contact:
        • Principal Investigator:
          • Visanu Thamlikitkul, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Colistin
Colistimethate sodium 2.5-5mg/kg iv
Drug: Colistin
Colistimethate sodium 2.5-5mg/kg iv per day
Other Names:
  • 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 Names:
  • vitamin c

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of patients with Renal toxicity associated with colistin
Time Frame: up to 28 days
Renal toxicity associated with colistin according to RIFLE criteria
up to 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of subjects with cure or improvement
Time Frame: up to 28 days
cure improvement worse death
up to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Collaborators

Siriraj Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

December 24, 2011

First Submitted That Met QC Criteria

December 29, 2011

First Posted (Estimate)

December 30, 2011

Study Record Updates

Last Update Posted (Estimate)

December 30, 2011

Last Update Submitted That Met QC Criteria

December 29, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEU 2012-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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