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

Primary Purpose

Ventilator Associated Pneumonia ( VAP), Sepsis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Vitamin C
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Ventilator Associated Pneumonia ( VAP) focused on measuring Vitamin C, Sepsis, Intensive care unit, Mechanically ventilation, VAP

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Ain Shams University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Study Group ( High dose vitamin C group )

Control Group (Daily requirements vitamin C Group )

Arm 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.

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

Outcomes

Primary Outcome Measures

The Incidence of Ventilator -Associated Pneumonia ( VAP)
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
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
SOFA (Sepsis -related Organ Failure assessment) score

Secondary Outcome Measures

28 day Mortality rate
length of stay in intensive care unit
changes in Glutathione Peroxidase enzyme (GPX) activity
duration of vasopressor support
Ventilator-free days (28-days Cumulative )

Full Information

First Posted
July 11, 2019
Last Updated
July 18, 2020
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04029675
Brief Title
High Dose of Vitamin C on Mechanically Ventilated Septic Patients in Intensive Care Unit
Official Title
The Effect of High Dose of Vitamin C on the Clinical Outcome of Mechanically Ventilated Patients Following Sepsis in Intensive Care Unit
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
July 15, 2019 (Actual)
Primary Completion Date
January 15, 2020 (Actual)
Study Completion Date
February 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator Associated Pneumonia ( VAP), Sepsis
Keywords
Vitamin C, Sepsis, Intensive care unit, Mechanically ventilation, VAP

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double blinded ,Prospective, Randomized clinical trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Group ( High dose vitamin C group )
Arm Type
Experimental
Arm 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.
Arm Title
Control Group (Daily requirements vitamin C Group )
Arm Type
Active Comparator
Arm 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
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin C
Intervention Description
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 Outcome Measure Information:
Title
The Incidence of Ventilator -Associated Pneumonia ( VAP)
Description
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
Time Frame
within 28 days
Title
Plasma Vitamin C level after administration of study drug
Description
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
Time Frame
within 7 days of administered of vitamin C
Title
change in SOFA score
Description
SOFA (Sepsis -related Organ Failure assessment) score
Time Frame
within 7 days of administered of vitamin C
Secondary Outcome Measure Information:
Title
28 day Mortality rate
Time Frame
average 28 days
Title
length of stay in intensive care unit
Time Frame
through the study completion, average 6 months
Title
changes in Glutathione Peroxidase enzyme (GPX) activity
Time Frame
within 7 days of administered of vitamin C
Title
duration of vasopressor support
Time Frame
Average28 days
Title
Ventilator-free days (28-days Cumulative )
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara M. Shahen, MD
Organizational Affiliation
Ain Shams University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ibrahim E. Mamdoh, MD
Organizational Affiliation
Ain Shams University
Official's Role
Study Chair
Facility Information:
Facility Name
Ain Shams University Hospitals
City
Cairo
State/Province
EL Abbasia
ZIP/Postal Code
002
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
data that to be shared are age & gender of the participants
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High Dose of Vitamin C on Mechanically Ventilated Septic Patients in Intensive Care Unit

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