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Efficacy of Ascorbic Acid for Prevention of Colistin-Associated Nephrotoxicity

NCT ID: NCT01501968

Last Updated: 2011-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-12-31

Brief Summary

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Ascorbic acid (Vitamin C) could protect renal toxicity from colistin.

Detailed Description

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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.

Conditions

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Drug Safety

Keywords

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Colistin ascorbic acid renal toxicity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Colistin

Colistimethate sodium 2.5-5mg/kg iv

Group Type ACTIVE_COMPARATOR

Colistin

Intervention Type DRUG

Colistimethate sodium 2.5-5mg/kg iv per day

Colistin + Ascorbic acid

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

Group Type EXPERIMENTAL

Colistin + Ascorbic acid

Intervention Type DRUG

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

Interventions

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Colistin

Colistimethate sodium 2.5-5mg/kg iv per day

Intervention Type DRUG

Colistin + Ascorbic acid

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

Intervention Type DRUG

Other Intervention Names

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Colistate vitamin c

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Siriraj Hospital

OTHER

Sponsor Role collaborator

Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Visanu Thamlikitkul, MD

Role: PRINCIPAL_INVESTIGATOR

Siriraj Hospital

Locations

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Siriraj Hospital

Bangkok, Bangkok, Thailand

Site Status

Countries

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Thailand

Central Contacts

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Visanu Thamlikitkul, MD

Role: CONTACT

Phone: 662-419-7783

Email: [email protected]

Facility Contacts

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Visanu Thamlikitkul, MD

Role: primary

References

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Sirijatuphat R, Limmahakhun S, Sirivatanauksorn V, Nation RL, Li J, Thamlikitkul V. Preliminary clinical study of the effect of ascorbic acid on colistin-associated nephrotoxicity. Antimicrob Agents Chemother. 2015;59(6):3224-32. doi: 10.1128/AAC.00280-15. Epub 2015 Mar 23.

Reference Type DERIVED
PMID: 25801556 (View on PubMed)

Related Links

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http://mahidol.ac.th

mahidol webpage

Other Identifiers

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CEU 2012-01

Identifier Type: -

Identifier Source: org_study_id