Impact of Ascorbic Acid in the Prevention of Vancomycin Induced Nephrotoxicty
Evaluation of the Impact of Ascorbic Acid in the Prevention of Vancomycin Induced Nephrotoxicity
1 other identifier
interventional
40
1 country
1
Brief Summary
A Randomized controlled trial aiming to investigate whether ascorbic acid has a role in preventing vancomycin induced nephrotoxicity or not in critically ill patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 17, 2019
CompletedFirst Submitted
Initial submission to the registry
April 16, 2019
CompletedFirst Posted
Study publicly available on registry
April 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedJanuary 10, 2020
January 1, 2020
1.5 years
April 16, 2019
January 8, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of nephrotoxicty
Incidence of nephrotoxicty will be described according to RIFLE criteria
one week
Secondary Outcomes (1)
28 days Mortality
one month
Study Arms (2)
Vancomycin only
NO INTERVENTIONVancomycin 15-20mg/kg intravenous every 8-12 hours.
Vancomycin +Ascorbic acid
EXPERIMENTALVancomycin 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.
Interventions
ascorbic acid is an antioxidant that is expected to prevent nephrotoxicty induced by Vancomycin.
Eligibility Criteria
You may qualify if:
- Adults who are critically ill and with MRSA infection suspection.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cairo university hospitals
Cairo, 11562, Egypt
Related Publications (1)
Hesham El-Sherazy N, Samir Bazan N, Mahmoud Shaheen S, A Sabri N. Impact of ascorbic acid in reducing the incidence of vancomycin associated nephrotoxicity in critically ill patients: A preliminary randomized controlled trial. F1000Res. 2021 Sep 16;10:929. doi: 10.12688/f1000research.55619.1. eCollection 2021.
PMID: 34621519DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Nagwa A Sabry, PhD
Ain Shams University
- STUDY DIRECTOR
Sara M Shaheen, PhD
Ain Shams University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- clinical pharmacist at the critical care medicine unit- Cairo university hospitals
Study Record Dates
First Submitted
April 16, 2019
First Posted
April 19, 2019
Study Start
January 17, 2019
Primary Completion
July 1, 2020
Study Completion
September 1, 2020
Last Updated
January 10, 2020
Record last verified: 2020-01