<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03780933</url>
  </required_header>
  <id_info>
    <org_study_id>247</org_study_id>
    <nct_id>NCT03780933</nct_id>
  </id_info>
  <brief_title>the Effect of High Dose Ascorbic Acid on Critically Ill Patients With ARDS</brief_title>
  <official_title>The Impact of High Dose Vitamin C &quot;Ascorbic Acid&quot; on the Clinical Outcomes of Critically Ill Patients With Acute Respiratory Distress Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Misr International University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Misr International University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      1. To access role of vitamin C supplementation in ARDS patients on the following:&#xD;
&#xD;
           Oxidants/ antioxidants imbalance Length of hospital stay Mortality rate Weaning from&#xD;
           mechanical ventilator Incidence of adverse drug reaction&#xD;
&#xD;
        2. To access tolerability of vitamin C supplementation in patients with ARDS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Acute Respiratory distress syndrome (ARDS) is a form of severe hypoxemic respiratory failure&#xD;
      due to severe impairment of gas exchange and lung mechanics that is characterized by&#xD;
      inflammatory injury to the alveolar capillary barrier, with extravasation of protein-rich&#xD;
      edema fluid into the air space. Current ARDS antioxidant treatment strategy, is based upon&#xD;
      supportive therapies including low tidal volume ventilation, fluid management, nutritional&#xD;
      support and glucocorticoids.&#xD;
&#xD;
      Ascorbic acid or Vitamin C is an important dietary water-soluble antioxidant, it&#xD;
      significantly decreases the adverse effects of ROS such as reactive oxygen and nitrogen&#xD;
      species that can cause oxidative damage to macromolecules. Recent studies show that high dose&#xD;
      of Vitamin C have protective effects against overwhelming oxidative stress due to critical&#xD;
      illness. Vitamin C improves immune function and improves tissue perfusion and reduce tissue&#xD;
      hypoxia and subsequent organ dysfunction. Also, Ascorbate, the redox form of vitamin C is&#xD;
      physiological antioxidant and has bacteriostatic activity Hence the study aims to evaluate&#xD;
      the impact of IV Vitamin C in ARDS, as a novel pharmaceutical approach in an attempt to&#xD;
      improve the clinical outcome of ARDS patients, decrease other medications toxicities and&#xD;
      improve patients' quality of life.&#xD;
&#xD;
      The objective of the current study was to evaluate the efficacy, safety and tolerability of&#xD;
      IV Vitamin C administration in addition to conventional therapy in patients with ARDS by&#xD;
      assessing the following:&#xD;
&#xD;
        1. Oxidants/ antioxidants imbalance&#xD;
&#xD;
        2. Length of hospital stay&#xD;
&#xD;
        3. Mortality rate&#xD;
&#xD;
        4. Weaning from mechanical ventilator&#xD;
&#xD;
        5. Incidence of adverse drug reaction&#xD;
&#xD;
        6. Serum IL8 levels&#xD;
&#xD;
      8. Serum Vitamin C levels&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 5, 2017</start_date>
  <completion_date type="Actual">June 20, 2019</completion_date>
  <primary_completion_date type="Actual">June 20, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of Improvement in ARDS patient's mortality rate</measure>
    <time_frame>within 10 days of ARDS diagnosis</time_frame>
    <description>Days to weaning from ventilator</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intensive Care Unit Length of Stay</measure>
    <time_frame>subject will be followed until discharged from the ICU, has deceased, or study duration has reached 10days from time of enrollment, whichever is first</time_frame>
    <description>improvement in clinical outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Mechanical Ventilation</measure>
    <time_frame>subject will be followed until mechanical ventilation has been discontinued, the subject has deceased, or study duration has reached 10 days from time of enrollment, whichever is first</time_frame>
    <description>improvement in respiratory functions</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Acute Respiratory Distress</condition>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>conventional treatment (corticosteroids, mechanical ventilation)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>test group (vitamin C)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>high dose vitamin c iv infusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>vitamin c</intervention_name>
    <description>vitamin c IV 10 G</description>
    <arm_group_label>test group (vitamin C)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. All ARDS cases presenting to the Chest department ICU within 48 hours of diagnosis&#xD;
&#xD;
          2. who don't have an exclusion criteria will be included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known allergy to Vitamin C&#xD;
&#xD;
          2. Inability to obtain consent;&#xD;
&#xD;
          3. Age &lt; 18 years;&#xD;
&#xD;
          4. More than 48 hours since meeting ARDS criteria;&#xD;
&#xD;
          5. Pregnancy or breast feeding,&#xD;
&#xD;
          6. Moribund patient not expected to survive 24 hours;&#xD;
&#xD;
          7. Patients not eligible to CPR&#xD;
&#xD;
          8. Active kidney stone&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nada Farrag, Msc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Misr International University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Embaba Chest Hospitals</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>August 8, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>October 1, 2019</last_update_submitted>
  <last_update_submitted_qc>October 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Misr International University</investigator_affiliation>
    <investigator_full_name>Nada Hazem Farrag</investigator_full_name>
    <investigator_title>Assistant Lecturer</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03780933
org study id: 247
nct id: NCT03780933
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
1. To access role of vitamin C supplementation in ARDS patients on the following:

           Oxidants/ antioxidants imbalance Length of hospital stay Mortality rate Weaning from
           mechanical ventilator Incidence of adverse drug reaction

        2. To access tolerability of vitamin C supplementation in patients with ARDS.
Acute Respiratory distress syndrome (ARDS) is a form of severe hypoxemic respiratory failure
      due to severe impairment of gas exchange and lung mechanics that is characterized by
      inflammatory injury to the alveolar capillary barrier, with extravasation of protein-rich
      edema fluid into the air space. Current ARDS antioxidant treatment strategy, is based upon
      supportive therapies including low tidal volume ventilation, fluid management, nutritional
      support and glucocorticoids.

      Ascorbic acid or Vitamin C is an important dietary water-soluble antioxidant, it
      significantly decreases the adverse effects of ROS such as reactive oxygen and nitrogen
      species that can cause oxidative damage to macromolecules. Recent studies show that high dose
      of Vitamin C have protective effects against overwhelming oxidative stress due to critical
      illness. Vitamin C improves immune function and improves tissue perfusion and reduce tissue
      hypoxia and subsequent organ dysfunction. Also, Ascorbate, the redox form of vitamin C is
      physiological antioxidant and has bacteriostatic activity Hence the study aims to evaluate
      the impact of IV Vitamin C in ARDS, as a novel pharmaceutical approach in an attempt to
      improve the clinical outcome of ARDS patients, decrease other medications toxicities and
      improve patients' quality of life.

      The objective of the current study was to evaluate the efficacy, safety and tolerability of
      IV Vitamin C administration in addition to conventional therapy in patients with ARDS by
      assessing the following:

        1. Oxidants/ antioxidants imbalance

        2. Length of hospital stay

        3. Mortality rate

        4. Weaning from mechanical ventilator

        5. Incidence of adverse drug reaction

        6. Serum IL8 levels

      8. Serum Vitamin C levels
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Assessment of Improvement in ARDS patient's mortality rate
time frame: within 10 days of ARDS diagnosis
description: Days to weaning from ventilator
measure: Intensive Care Unit Length of Stay
time frame: subject will be followed until discharged from the ICU, has deceased, or study duration has reached 10days from time of enrollment, whichever is first
description: improvement in clinical outcome
measure: Duration of Mechanical Ventilation
time frame: subject will be followed until mechanical ventilation has been discontinued, the subject has deceased, or study duration has reached 10 days from time of enrollment, whichever is first
description: improvement in respiratory functions
arm group label: control group
arm group type: No Intervention
description: conventional treatment (corticosteroids, mechanical ventilation)
arm group label: test group (vitamin C)
arm group type: Experimental
description: high dose vitamin c iv infusion
intervention type: Dietary Supplement
intervention name: vitamin c
description: vitamin c IV 10 G
arm group label: test group (vitamin C)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Nada Farrag, Msc
role: Principal Investigator
affiliation: Misr International University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Misr International University
investigator full name: Nada Hazem Farrag
investigator title: Assistant Lecturer
sharing ipd: No