Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT01501968
NCT01501968UnknownPhase 3

Efficacy of Ascorbic Acid for Prevention of Colistin-Associated Nephrotoxicity

Mahidol University1 site in 1 country54 target enrollmentStarted: January 2012Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Enrollment
54
Locations
1
Primary Endpoint
number of patients with Renal toxicity associated with colistin
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts 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

Arms & Interventions

Colistin

Active Comparator

Colistimethate sodium 2.5-5mg/kg iv

Intervention: Colistin (Drug)

Colistin + Ascorbic acid

Experimental

Colistimethate sodium 2.5-5mg/kg iv and ascorbic acid 2 grams iv every 12 hours

Intervention: Colistin + Ascorbic acid (Drug)

Outcomes

Primary Outcomes

number of patients with Renal toxicity associated with colistin

Time Frame: up to 28 days

Renal toxicity associated with colistin according to RIFLE criteria

Secondary Outcomes

  • number of subjects with cure or improvement(up to 28 days)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

Not yet recruiting
Not Applicable
Alpha-tocopherol to reduced colistin nephrotoxicity in hospitalized patient(BAH)pilot study RCTAKIFollow up AKI by cr and serum NGALVitamin EColistin
TCTR20190730001VitaminE40
Recruiting
Phase 2
A pilot clinical study of Vitamin C for the prevention of acute kidney injury in critically ill patientsRenal and Urogenital - Kidney diseasekidney injury
ACTRN12619000909123Professor Rinaldo Bellomo50
Completed
Phase 4
NASPI: N-Acetylcysteine vs. Ascorbic Acid for Prevention of Contrast Induced Nephropathy in Renal Insufficiency Undergoing Coronary CatheterizationKidney Failure
NCT00356954Seoul National University Hospital250
Recruiting
Phase 3
Ascorbic acid in contrast-induced nephropathy
IRCT20151109024975N7Mazandaran University of Medical sciences100
Completed
Not Applicable
Vitamin C effectiveness in prevention of contrast mediated nephropathy in patients underwent coronary angiographyContrast-Induced Nephropathy.Nephropathy induced by other drugs, medicaments and biological substancesN 14.1
IRCT2015030918741N1Vice chancellor for research of Mazandaran University of Medical Sciences320