Impact of Ascorbic Acid in the Prevention of Vancomycin Induced Nephrotoxicty

Study Overview
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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.

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

Conditions
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Acute Kidney Injury

Intervention / Treatment
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* Drug: Ascorbic Acid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Vancomycin only<br>Vancomycin 15-20mg/kg intravenous every 8-12 hours. | |
| Experimental: Vancomycin +Ascorbic acid<br>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<br>* ascorbic acid is an antioxidant that is expected to prevent nephrotoxicty induced by Vancomycin.<br>* Other names: Vitamin C;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of nephrotoxicty | Incidence of nephrotoxicty will be described according to RIFLE criteria | one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28 days Mortality |  | one month |