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Impact of Ascorbic Acid in the Prevention of Vancomycin Induced Nephrotoxicty

Primary Purpose

Acute Kidney Injury

Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Ascorbic Acid
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Acute Kidney Injury

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cairo university hospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Vancomycin only

Vancomycin +Ascorbic acid

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Incidence of nephrotoxicty
Incidence of nephrotoxicty will be described according to RIFLE criteria

Secondary Outcome Measures

28 days Mortality

Full Information

First Posted
April 16, 2019
Last Updated
January 8, 2020
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT03921099
Brief Title
Impact of Ascorbic Acid in the Prevention of Vancomycin Induced Nephrotoxicty
Official Title
Evaluation of the Impact of Ascorbic Acid in the Prevention of Vancomycin Induced Nephrotoxicity
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 17, 2019 (Actual)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vancomycin only
Arm Type
No Intervention
Arm Description
Vancomycin 15-20mg/kg intravenous every 8-12 hours.
Arm Title
Vancomycin +Ascorbic acid
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ascorbic Acid
Other Intervention Name(s)
Vitamin C
Intervention Description
ascorbic acid is an antioxidant that is expected to prevent nephrotoxicty induced by Vancomycin.
Primary Outcome Measure Information:
Title
Incidence of nephrotoxicty
Description
Incidence of nephrotoxicty will be described according to RIFLE criteria
Time Frame
one week
Secondary Outcome Measure Information:
Title
28 days Mortality
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults who are critically ill and with MRSA infection suspection. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nouran H Elsherazy, Bachelor
Phone
+201224959630
Email
Nouran_elsherazy@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Naglaa S Bazan, PhD
Email
NaglaaBazan@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nagwa A Sabry, PhD
Organizational Affiliation
Ain Shams University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sara M Shaheen, PhD
Organizational Affiliation
Ain Shams University
Official's Role
Study Director
Facility Information:
Facility Name
Cairo university hospitals
City
Cairo
ZIP/Postal Code
11562
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Critical care department Cairo university Hopsitals

12. IPD Sharing Statement

Citations:
PubMed Identifier
34621519
Citation
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.
Results Reference
derived

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Impact of Ascorbic Acid in the Prevention of Vancomycin Induced Nephrotoxicty

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