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

July 18, 2020 updated by: Wessam Adel El Sayed Abdel Aziz El Driny, Ain Shams University

The Effect of High Dose of Vitamin C on the Clinical Outcome of Mechanically Ventilated Patients Following Sepsis 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • EL Abbasia
      • Cairo, EL Abbasia, Egypt, 002
        • Ain Shams University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Study Group ( High dose vitamin C group )
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.
Dietary supplement: 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
ACTIVE_COMPARATOR: Control Group (Daily requirements vitamin C Group )
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
Dietary supplement: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within 28 days
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
within 7 days of administered of vitamin C
change in SOFA score
Time Frame: within 7 days of administered of vitamin C
SOFA (Sepsis -related Organ Failure assessment) score
within 7 days of administered of vitamin C

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Chair: Sara M. Shahen, MD, Ain Shams University
  • Study Chair: Ibrahim E. Mamdoh, MD, Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 15, 2019

Primary Completion (ACTUAL)

January 15, 2020

Study Completion (ACTUAL)

February 15, 2020

Study Registration Dates

First Submitted

July 11, 2019

First Submitted That Met QC Criteria

July 21, 2019

First Posted (ACTUAL)

July 23, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 21, 2020

Last Update Submitted That Met QC Criteria

July 18, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Faculty of Pharmacy_AinShamsU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

data that to be shared are age & gender of the participants

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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