Impact of Ascorbic Acid in the Prevention of Vancomycin Induced Nephrotoxicty

Phase 4

• Conditions: Acute Kidney Injury
• Interventions: Drug: Ascorbic Acid

• Registration Number: NCT03921099
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Study Start: 2019-01-17
• Study First Submitted: 2019-04-16
• Study First Submitted QC: 2019-04-17
• Study First Posted: 2019-04-19
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-08
• Last Update Posted: 2020-01-10
• Primary Completion: 2020-07
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vancomycin +Ascorbic acid	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.

Primary Outcome Measures

Name	Time	Method
Incidence of nephrotoxicty	one week	Incidence of nephrotoxicty will be described according to RIFLE criteria

Secondary Outcome Measures

Name	Time	Method
28 days Mortality	one month

Trial Locations

Locations (1)

Cairo university hospitals; 🇪🇬 Cairo, Egypt