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

Ain Shams University

Status: Completed

Conditions: Ventilator Associated Pneumonia ( VAP); Sepsis

Treatments: Dietary Supplement: Vitamin C

Study type: Interventional

Funder types: Other

Identifiers

NCT04029675

Faculty of Pharmacy_AinShamsU

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

Study Group ( High dose vitamin C group )

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Vitamin C

Control Group (Daily requirements vitamin C Group )

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Vitamin C