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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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03921099
Enrollment
40
Registered
2019-04-19
Start date
2019-01-17
Completion date
2020-09-30
Last updated
2020-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury

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.

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.

Interventions

DRUGAscorbic Acid

ascorbic acid is an antioxidant that is expected to prevent nephrotoxicty induced by Vancomycin.

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Adults who are critically ill and with MRSA infection suspection.

Exclusion criteria

1. Pregnancy or breast feeding. 2. Known allergy to either vancomycin or ascorbic acid. 3. Base line serum creatinine ≥2mg/dl. 4. Patients receiving other nephrotoxic drug (e.g., aminoglycosides, amphotericin B, cisplatin or calcinurine inhibitors). 5. Anticepated administration of contrast medium within 7 days. 6. Patients suffering from some underlying diseases (e.g., cancer, HIV infection, systemic lupus erythematoses,or urinary tract stones). 7. Unlikelyhood of receiving the study medications for at least 72 hours

Design outcomes

Primary

MeasureTime frameDescription
Incidence of nephrotoxictyone weekIncidence of nephrotoxicty will be described according to RIFLE criteria

Secondary

MeasureTime frame
28 days Mortalityone month

Countries

Egypt

Contacts

Primary ContactNouran H Elsherazy, Bachelor
Nouran_elsherazy@yahoo.com+201224959630
Backup ContactNaglaa S Bazan, PhD
NaglaaBazan@yahoo.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026