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

Not Applicable

Completed

• Conditions: Ventilator Associated Pneumonia ( VAP); Sepsis
• Interventions: Dietary Supplement: Vitamin C

• Registration Number: NCT04029675
• Lead Sponsor: Ain Shams University

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

Study Timeline

• Study First Submitted: 2019-07-11
• Study Start: 2019-07-15
• Study First Submitted QC: 2019-07-21
• Study First Posted: 2019-07-23
• Primary Completion: 2020-01-15
• Study Completion: 2020-02-15
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-18
• Last Update Posted: 2020-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group ( High dose vitamin C group )	Vitamin C	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.
Control Group (Daily requirements vitamin C Group )	Vitamin C	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

Primary Outcome Measures

Name	Time	Method
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
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
change in SOFA score	within 7 days of administered of vitamin C	SOFA (Sepsis -related Organ Failure assessment) score

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ain Shams University Hospitals; 🇪🇬 Cairo, EL Abbasia, Egypt