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

Ain Shams University40 enrolled

Overview

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.

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: 1. Complete history taking. 2. Full clinical examination 3. Evaluation and monitoring of(pulse oximetry , ECG, NIBP, temperature) 4. CBC , Blood gas (for determination of (PaO2/FiO2), Blood cultures,serum Creatinine and total bilirubin were recorded daily for the first 7 days. 5. Severity scores by calculating Acute physiology and chronic health evaluation (APACHE II)score

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Ventilator Associated Pneumonia ( VAP)Sepsis

Interventions

Vitamin CDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Ain Shams University Hospitals

Cairo, EL Abbasia, Egypt

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: within 7 days of administered of vitamin C

change in SOFA score

SOFA (Sepsis -related Organ Failure assessment) score

Time frame: within 7 days of administered of vitamin C

Secondary Outcomes

28 day Mortality rate

Time frame: average 28 days

length of stay in intensive care unit

Time frame: through the study completion, average 6 months

changes in Glutathione Peroxidase enzyme (GPX) activity

Time frame: within 7 days of administered of vitamin C

duration of vasopressor support

Time frame: Average28 days

Ventilator-free days (28-days Cumulative )

Time frame: 28 days

Data from ClinicalTrials.gov

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