Impact of Ascorbic Acid in the Prevention of Vancomycin Induced Nephrotoxicty

Acute Kidney Injury Clinical Trial

Official title:

Evaluation of the Impact of Ascorbic Acid in the Prevention of Vancomycin Induced Nephrotoxicity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03921099
• Other study ID #: 208
• Status: Recruiting
• Phase: Phase 4
• Start date: January 17, 2019
• Est. completion date: September 2020

Study information

• Verified date: January 2020
• Source: Ain Shams University
• Contact: Nouran H Elsherazy, Bachelor
• Phone: +201224959630
• Email: Nouran_elsherazy[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Drug:
• Ascorbic Acid
ascorbic acid is an antioxidant that is expected to prevent nephrotoxicty induced by Vancomycin.

Locations

Country	Name	City	State
Egypt	Cairo university hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of nephrotoxicty	Incidence of nephrotoxicty will be described according to RIFLE criteria	one week
Secondary	28 days Mortality		one month