ClinicalTrials.gg
Status unknownNCT03921099Updated Jan 10, 2020

Impact of Ascorbic Acid in the Prevention of Vancomycin Induced Nephrotoxicty

A Phase 4 interventional study of Ascorbic Acid in Acute Kidney Injury, sponsored by Ain Shams University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-01-10.

Sponsored by Ain Shams University · Phase 4, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Acute Kidney Injury

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03

In context

Acute Kidney Injury

1,641 studies on the registry are indexed under Acute Kidney Injury; 380 are open to participants now.

This study's planned enrollment of 40 is below the median of 100 across 786 interventional studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,930 studies on the registry; 433 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Phase 4
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • No intervention
    Vancomycin only

    Vancomycin 15-20mg/kg intravenous every 8-12 hours.

  • 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.

    Drug: Ascorbic Acid

Interventions

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

    Also known as: Vitamin C

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What researchers measure

Primary outcomes

  1. Incidence of nephrotoxicty

    Incidence of nephrotoxicty will be described according to RIFLE criteria

    Time frame: one week

Secondary outcomes

  1. 28 days Mortality

    Time frame: one month

07

Study locations

1 of 1 sites recruiting
  • Cairo university hospitals
    Cairo, 11562, Egypt
    • Critical care department Cairo university Hopsitals · Contact
    Recruiting
08

References and documents

Publications

  • 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. PubMed 34621519 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03921099
Responsible party
Nouran Hesham Ali (clinical pharmacist at the critical care medicine unit- Cairo university hospitals, Ain Shams University) — Principal investigator
First posted
Apr 19, 2019
Start date
Jan 17, 2019
Primary completion
Jul 2020 (estimated)
Completion
Sep 2020 (estimated)
Last update
Jan 10, 2020

Study contacts

Nouran H Elsherazy, Bachelor
Contact
Nouran_elsherazy@yahoo.com
+201224959630
Naglaa S Bazan, PhD
Contact
NaglaaBazan@yahoo.com
Nagwa A Sabry, PhD
study director · Ain Shams University
Sara M Shaheen, PhD
study director · Ain Shams University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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