Impact of Ascorbic Acid in the Prevention of Vancomycin Induced Nephrotoxicty

NCT ID: NCT03921099

Last Updated: 2020-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-17

Study Completion Date

2020-09-30

Brief Summary

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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

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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.

Conditions

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Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Vancomycin only

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Ascorbic Acid

Intervention Type DRUG

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

Interventions

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Ascorbic Acid

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

Intervention Type DRUG

Other Intervention Names

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Vitamin C

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Nouran Hesham Ali

clinical pharmacist at the critical care medicine unit- Cairo university hospitals

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nagwa A Sabry, PhD

Role: STUDY_DIRECTOR

Ain Shams University

Sara M Shaheen, PhD

Role: STUDY_DIRECTOR

Ain Shams University

Locations

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Cairo university hospitals

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Nouran H Elsherazy, Bachelor

Role: CONTACT

+201224959630

Naglaa S Bazan, PhD

Role: CONTACT

Facility Contacts

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Critical care department Cairo university Hopsitals

Role: primary

References

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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.

Reference Type DERIVED
PMID: 34621519 (View on PubMed)

Other Identifiers

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208

Identifier Type: -

Identifier Source: org_study_id

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