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Completed

NCT Number: NCT04029675

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

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin C

Dietary 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

Primary outcomes

  1. The Incidence of Ventilator -Associated Pneumonia ( VAP)

    Time frame: 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

  2. Plasma Vitamin C level after administration of study drug

    Time frame: 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

  3. change in SOFA score

    Time frame: within 7 days of administered of vitamin C

    SOFA (Sepsis -related Organ Failure assessment) score

Secondary outcomes

  1. 28 day Mortality rate

    Time frame: average 28 days

  2. length of stay in intensive care unit

    Time frame: through the study completion, average 6 months

  3. changes in Glutathione Peroxidase enzyme (GPX) activity

    Time frame: within 7 days of administered of vitamin C

  4. duration of vasopressor support

    Time frame: Average28 days

  5. Ventilator-free days (28-days Cumulative )

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 23, 2019
Registry last updated
Jul 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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