Sepsis, Ventilator Associated Pneumonia ( VAP)
Conditions
Keywords
Vitamin C, Sepsis, Intensive care unit, Mechanically ventilation, VAP
Brief summary
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
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
Interventions
DIETARY_SUPPLEMENTVitamin C
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
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Double blinded ,Prospective, Randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Incidence of Ventilator -Associated Pneumonia ( VAP) | within 28 days | 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 |
| Plasma Vitamin C level after administration of study drug | within 7 days of administered of vitamin C | 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 |
| change in SOFA score | within 7 days of administered of vitamin C | SOFA (Sepsis -related Organ Failure assessment) score |
Secondary
| Measure | Time frame |
|---|---|
| duration of vasopressor support | Average28 days |
| 28 day Mortality rate | average 28 days |
| Ventilator-free days (28-days Cumulative ) | 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 |
Countries
Egypt
Outcome results
None listed