High Dose of Vitamin C on Mechanically Ventilated Septic Patients in Intensive Care Unit

Study Overview
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Brief Summary
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Prospective, Randomized clinical trial study will be carried out in intensive care unit in Ain Shams University Hospitals on 40 forty septic patients admitted to ICU and mechanically ventilated.

Detailed Description
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This study will be carried out in intensive care unit in Ain Shams University Hospitals , Cairo,Egypt on 40 patients admitted to ICU that are septic patients and mechanically ventilated which will be recruited into the study . After approval from ethical committee, an informed consent will be obtained from relatives of all patients. All data of patients will be confidential with secret codes and private file for each patient. Each patient's relative will receive an explanation for the purpose of the study. The study design will be prospective , randomized clinical trial. Methodology: All patients will be subjected to: Complete history taking. Full clinical examination Evaluation and monitoring of(pulse oximetry , ECG, NIBP, temperature) CBC , Blood gas (for determination of (PaO2/FiO2), Blood cultures,serum Creatinine and total bilirubin were recorded daily for the first 7 days. Severity scores by calculating Acute physiology and chronic health evaluation (APACHE II)score

Official Title
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The Effect of High Dose of Vitamin C on the Clinical Outcome of Mechanically Ventilated Patients Following Sepsis in Intensive Care Unit

Conditions
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Ventilator Associated Pneumonia ( VAP), Sepsis

Intervention / Treatment
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* Dietary Supplement: Vitamin C


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female Age from age≥18 years Septic patient admitted to ICU and mechanically ventilated diagnosed by sepsis criteria proposed by the American College of Chest Physicians/Society of Critical Care Medicine Expected to survive and remain in the ICU for at least 96 hours after study entry Exclusion Criteria: Age<18 years Pregnant females Patients with history of aspiration before intubation Respiratory distress syndrome Ischemic reperfusion injury Cancer as the cause of SIRS or sepsis Chronic kidney diseases Ongoing shock Allergy from interventional drug on the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blinded ,Prospective, Randomized clinical trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group ( High dose vitamin C group )<br>They will receive 1.5 gm intravenous (IV) Vitamin C in 100 ml dextrose 5% (D5W) administered as an infusion over 30 to 60 minutes every 6 hours daily for 4 days or until ICU discharge. | Dietary Supplement: Vitamin C<br>* Vitamin C is a strong antioxidant and has been shown to regenerate other antioxidants such as vitamin E, vitamin C also play an important role in immune function<br>|
| Active Comparator: Control Group (Daily requirements vitamin C Group )<br>They will receive standard daily requirements of Vitamin C intravenously which is 75-90 mg in 100 ml dextrose 5% (D5W) administered as an infusion over 30 to 60 minutes daily for 4 days or until ICU discharge | Dietary Supplement: Vitamin C<br>* Vitamin C is a strong antioxidant and has been shown to regenerate other antioxidants such as vitamin E, vitamin C also play an important role in immune function<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Incidence of Ventilator -Associated Pneumonia ( VAP) | Ventilator-associated pneumonia (VAP)is defined as pneumonia that occurs 48-72 hours or thereafter following endotracheal intubation, characterized by the presence of a new progressive infiltrate, signs of a systemic infection (fever, altered white blood cells count), changes in sputum characteristics, and detection of a causative agent | within 28 days | 
| Plasma Vitamin C level after administration of study drug | Vitamin C is a strong antioxidant and has been shown to regenerate other antioxidants such as vitamin E, vitamin C also play an important role in immune function | within 7 days of administered of vitamin C | 
| change in SOFA score | SOFA (Sepsis -related Organ Failure assessment) score | within 7 days of administered of vitamin C | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28 day Mortality rate |  | average 28 days | 
| length of stay in intensive care unit |  | through the study completion, average 6 months | 
| changes in Glutathione Peroxidase enzyme (GPX) activity |  | within 7 days of administered of vitamin C | 
| duration of vasopressor support |  | Average28 days | 
| Ventilator-free days (28-days Cumulative ) |  | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin C, Sepsis, Intensive care unit, Mechanically ventilation, VAP