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Impact of Ascorbic Acid in the Prevention of Vancomycin Induced Nephrotoxicty

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ClinicalTrials.gov Identifier: NCT03921099
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : January 10, 2020
Sponsor:
Information provided by (Responsible Party):
Nouran Hesham Ali, Ain Shams University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Drug: Ascorbic Acid Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluation of the Impact of Ascorbic Acid in the Prevention of Vancomycin Induced Nephrotoxicity
Actual Study Start Date : January 17, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin C

Arms and Interventions
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Arm Intervention/treatment
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
ascorbic acid is an antioxidant that is expected to prevent nephrotoxicty induced by Vancomycin.
Other Name: Vitamin C


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of nephrotoxicty [ Time Frame: one week ]
    Incidence of nephrotoxicty will be described according to RIFLE criteria


Secondary Outcome Measures :
  1. 28 days Mortality [ Time Frame: one month ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03921099


Contacts
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Contact: Nouran H Elsherazy, Bachelor +201224959630 Nouran_elsherazy@yahoo.com
Contact: Naglaa S Bazan, PhD NaglaaBazan@yahoo.com

Locations
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Egypt
Cairo university hospitals Recruiting
Cairo, Egypt, 11562
Contact: Critical care department Cairo university Hopsitals         
Sponsors and Collaborators
Ain Shams University
Investigators
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Study Director: Nagwa A Sabry, PhD Ain Shams University
Study Director: Sara M Shaheen, PhD Ain Shams University
More Information
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Responsible Party: Nouran Hesham Ali, clinical pharmacist at the critical care medicine unit- Cairo university hospitals, Ain Shams University
ClinicalTrials.gov Identifier: NCT03921099    
Other Study ID Numbers: 208
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: January 10, 2020
Last Verified: January 2020

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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
Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Ascorbic Acid
Vitamins
Micronutrients
 Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents