Impact of Ascorbic Acid in the Prevention of Vancomycin Induced Nephrotoxicty
January 8, 2020 updated by: Nouran Hesham Ali, Ain Shams University
Evaluation of the Impact of Ascorbic Acid in the Prevention of Vancomycin Induced Nephrotoxicity
A Randomized controlled trial aiming to investigate whether ascorbic acid has a role in preventing vancomycin induced nephrotoxicity or not in critically ill patients.
Study Overview
Detailed Description
Critically ill patients who have gram positive infection (MRSA) and need vancomycin will be assigned randomly into two groups.
The first group will be given vancomycin intravenous only (15-20 mg/kg) every 8-12 hours , while the second group will take vancomycin intravenous (15-20 mg/kg) every 8-12 hours plus ascorbic acid 1 gram twice daily orally just before the vancomycin administration by half an hour.
Patients will be monitored for one week where serum creatinine, BUN, urine output, trough level will be measured.
Acute kidney injury will be determined according to RIFLE criteria.
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Cairo, Egypt, 11562
- Recruiting
- Cairo university hospitals
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Contact:
- Critical care department Cairo university Hopsitals
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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
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adults who are critically ill and with MRSA infection suspection.
Exclusion Criteria:
- Pregnancy or breast feeding.
- Known allergy to either vancomycin or ascorbic acid.
- Base line serum creatinine ≥2mg/dl.
- Patients receiving other nephrotoxic drug (e.g., aminoglycosides, amphotericin B, cisplatin or calcinurine inhibitors).
- Anticepated administration of contrast medium within 7 days.
- Patients suffering from some underlying diseases (e.g., cancer, HIV infection, systemic lupus erythematoses,or urinary tract stones).
- Unlikelyhood of receiving the study medications for at least 72 hours
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: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Vancomycin only
Vancomycin 15-20mg/kg intravenous every 8-12 hours.
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Experimental: Vancomycin +Ascorbic acid
Vancomycin 15-20mg/kg intravenous every 8-12 hours.
Ascorbic acid 1gm every 12 hours orally just before vancomycin by half an hour for seven days.
|
ascorbic acid is an antioxidant that is expected to prevent nephrotoxicty induced by Vancomycin.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of nephrotoxicty
Time Frame: one week
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Incidence of nephrotoxicty will be described according to RIFLE criteria
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one week
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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28 days Mortality
Time Frame: one month
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one month
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Nagwa A Sabry, PhD, Ain Shams University
- Study Director: Sara M Shaheen, PhD, Ain Shams University
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.
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 (Actual)
January 17, 2019
Primary Completion (Anticipated)
July 1, 2020
Study Completion (Anticipated)
September 1, 2020
Study Registration Dates
First Submitted
April 16, 2019
First Submitted That Met QC Criteria
April 17, 2019
First Posted (Actual)
April 19, 2019
Study Record Updates
Last Update Posted (Actual)
January 10, 2020
Last Update Submitted That Met QC Criteria
January 8, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 208
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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.