<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/NCT04411160</url>
  </required_header>
  <id_info>
    <org_study_id>ICU-32-20</org_study_id>
    <nct_id>NCT04411160</nct_id>
  </id_info>
  <brief_title>Vitamin C Versus Nitric Oxide in Prolonged Ventilation</brief_title>
  <official_title>Comparative Study Between the Effect of Vitamin C vs. Nitric Oxide in Weaning of Patients With Prolonged Ventilation Due to ARDS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King Abdul Aziz Specialist Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King Abdul Aziz Specialist Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This a prospective double-blind study done in King Abdul-Aziz specialist hospital between&#xD;
      January 2019 and April 2020 in the intensive care unit on 60 patients with difficult weaning&#xD;
      and ventilated for 10 days. Allocated randomly in two groups 30 patients in each. All&#xD;
      patients in both groups continued on the same conventional ventilation but Group A received&#xD;
      nitric oxide (NO) while group B received vitamin C intravenous. The duration of the study&#xD;
      last 16 days. during this period, APCHII score, Hemodynamics, Chest Xray, hypoxic index, lung&#xD;
      compliance, Recruitment maneuver, arterial blood saturation, LDH, C-reactive protein used as&#xD;
      indicator for improvement. Number of patients weaned from the ventilator and patients died&#xD;
      also recorded.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All selected patients received conventional ventilation with protective lung strategy for 10&#xD;
      days with Controlled mechanical ventilation mode(CMV), fraction inspired oxygen (FIO2) of&#xD;
      100%, Positive end expiratory pressure(PEEP) of 10 cm H2O or more to achieve target arterial&#xD;
      oxygen saturation(SPO2) of 90% or more with sedation by midazolam infusion to achieve&#xD;
      Richmond Agitation- Sedation Scale (RASS) -2 to -3 and fentanyl infusion for pain control&#xD;
      between 50-100 mg/min. Protective lung strategy was strictly applied in form of head&#xD;
      elevation more than 30°, broad spectrum antibiotics according to our antibiotic regimen,&#xD;
      daily assessment for both analgesic and sedative dose were given to patients, early&#xD;
      naso-gastric feeding started to prevent ventilator associated pneumonia and daily trial was&#xD;
      done to reduce PEEP to prevent more lung injury from ventilation also qualitative sputum&#xD;
      culture was taken after one week from ventilation. After 10 days from the conventional&#xD;
      ventilation those who could not be weaned from the ventilator and still had the former&#xD;
      criteria mentioned before (Uncompensated hypercapnia with PH&lt;7.25, and/or Hypoxic index less&#xD;
      than 200) included in our study. Percutaneous dilatation tracheostomy done for all patients&#xD;
      in both groups. 60 patients randomly allocated in 2 groups. Randomization sequence was&#xD;
      created using Excel 2007 (Microsoft, Redmond, WA, USA) with a 1:1 allocation using random&#xD;
      block sizes of 2 and 4 by an independent doctor. In this way, sequence generation and type of&#xD;
      randomization can be expressed at the same time. Each group included 30 patients. Patients of&#xD;
      group A received inhalation of nitric oxide stared by 50 parts/billion(ppb) as starting dose&#xD;
      titrated according to patient's saturation reaching to 90 ppb as a maximum dose. While&#xD;
      patients of group B received 4 gram of vitamin c slowly intravenous once daily for 4 days&#xD;
      duration. Improvement of general condition of the patients monitored in our study by APACH II&#xD;
      score and core body temperature. improvement of the lungs condition monitored in our study&#xD;
      clinically by monitoring: oxygen saturation, hypoxic index, compliance and response to&#xD;
      recruitment maneuver ( Recruitment maneuver is considered clinical test of lung compliance&#xD;
      and start by increase the peak inspiratory pressure to 40 cm/H2O for 40 sec and observe the&#xD;
      saturation (SpO2) if improved to more than 95% considered responder in our study).(18) and&#xD;
      radiologically by size of parenchymatous lung infiltration on chest X ray. The duration of&#xD;
      the study 16 days&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2019</start_date>
  <completion_date type="Actual">April 21, 2020</completion_date>
  <primary_completion_date type="Actual">April 19, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>tissue oxygenation</measure>
    <time_frame>2 weeks</time_frame>
    <description>observe the arterial oxygen saturation SpO2</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>ARDS</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <description>Patients of group A received inhalation of nitric oxide stared by 50 parts/billion(ppb) as starting dose titrated according to patient's saturation reaching to 90 ppb as a maximum dose.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <description>While patients of group B received 4 gram of vitamin c slowly intravenous once daily for 4 days duration.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vitamin C</intervention_name>
    <description>4 gram of vitamin c slowly intravenous once daily for 4 days duration.</description>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nitric Oxide</intervention_name>
    <description>nitric oxide stared by 50 parts/billion(ppb) as starting dose titrated according to patient's saturation reaching to 90 ppb as a maximum dose</description>
    <arm_group_label>Group A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ventilators</intervention_name>
    <description>All selected patients received conventional ventilation with protective lung strategy for 10 days with Controlled mechanical ventilation mode(CMV), fraction inspired oxygen (FIO2) of 100%, Positive end expiratory pressure(PEEP) of 10 cm H2O or more to achieve target arterial oxygen saturation(SPO2) of 90%</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This a prospective cohort study done in King Abd el Aziz specialist hospital between&#xD;
        January 2019 and April 2020 in the intensive care unit on 60 patients with respiratory&#xD;
        failure and showed failure of weaning from ventilator either due to medical or surgical&#xD;
        causes. King Abdelaziz research and ethical committee approved the project.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ARDS&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  systemic disease as diabetes and hypertension&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>adult only</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>King abd el Aziz specialist hospital</name>
      <address>
        <city>Ta'if</city>
        <zip>21944</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>June 6, 2020</last_update_submitted>
  <last_update_submitted_qc>June 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nitric Oxide</mesh_term>
  </intervention_browse>
  <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/NCT04411160
org study id: ICU-32-20
nct id: NCT04411160
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This a prospective double-blind study done in King Abdul-Aziz specialist hospital between
      January 2019 and April 2020 in the intensive care unit on 60 patients with difficult weaning
      and ventilated for 10 days. Allocated randomly in two groups 30 patients in each. All
      patients in both groups continued on the same conventional ventilation but Group A received
      nitric oxide (NO) while group B received vitamin C intravenous. The duration of the study
      last 16 days. during this period, APCHII score, Hemodynamics, Chest Xray, hypoxic index, lung
      compliance, Recruitment maneuver, arterial blood saturation, LDH, C-reactive protein used as
      indicator for improvement. Number of patients weaned from the ventilator and patients died
      also recorded.
All selected patients received conventional ventilation with protective lung strategy for 10
      days with Controlled mechanical ventilation mode(CMV), fraction inspired oxygen (FIO2) of
      100%, Positive end expiratory pressure(PEEP) of 10 cm H2O or more to achieve target arterial
      oxygen saturation(SPO2) of 90% or more with sedation by midazolam infusion to achieve
      Richmond Agitation- Sedation Scale (RASS) -2 to -3 and fentanyl infusion for pain control
      between 50-100 mg/min. Protective lung strategy was strictly applied in form of head
      elevation more than 30°, broad spectrum antibiotics according to our antibiotic regimen,
      daily assessment for both analgesic and sedative dose were given to patients, early
      naso-gastric feeding started to prevent ventilator associated pneumonia and daily trial was
      done to reduce PEEP to prevent more lung injury from ventilation also qualitative sputum
      culture was taken after one week from ventilation. After 10 days from the conventional
      ventilation those who could not be weaned from the ventilator and still had the former
      criteria mentioned before (Uncompensated hypercapnia with PH<7.25, and/or Hypoxic index less
      than 200) included in our study. Percutaneous dilatation tracheostomy done for all patients
      in both groups. 60 patients randomly allocated in 2 groups. Randomization sequence was
      created using Excel 2007 (Microsoft, Redmond, WA, USA) with a 1:1 allocation using random
      block sizes of 2 and 4 by an independent doctor. In this way, sequence generation and type of
      randomization can be expressed at the same time. Each group included 30 patients. Patients of
      group A received inhalation of nitric oxide stared by 50 parts/billion(ppb) as starting dose
      titrated according to patient's saturation reaching to 90 ppb as a maximum dose. While
      patients of group B received 4 gram of vitamin c slowly intravenous once daily for 4 days
      duration. Improvement of general condition of the patients monitored in our study by APACH II
      score and core body temperature. improvement of the lungs condition monitored in our study
      clinically by monitoring: oxygen saturation, hypoxic index, compliance and response to
      recruitment maneuver ( Recruitment maneuver is considered clinical test of lung compliance
      and start by increase the peak inspiratory pressure to 40 cm/H2O for 40 sec and observe the
      saturation (SpO2) if improved to more than 95% considered responder in our study).(18) and
      radiologically by size of parenchymatous lung infiltration on chest X ray. The duration of
      the study 16 days
observational model: Cohort
time perspective: Prospective
measure: tissue oxygenation
time frame: 2 weeks
description: observe the arterial oxygen saturation SpO2
arm group label: Group A
description: Patients of group A received inhalation of nitric oxide stared by 50 parts/billion(ppb) as starting dose titrated according to patient's saturation reaching to 90 ppb as a maximum dose.
arm group label: Group B
description: While patients of group B received 4 gram of vitamin c slowly intravenous once daily for 4 days duration.
intervention type: Drug
intervention name: Vitamin C
description: 4 gram of vitamin c slowly intravenous once daily for 4 days duration.
arm group label: Group B
intervention type: Drug
intervention name: Nitric Oxide
description: nitric oxide stared by 50 parts/billion(ppb) as starting dose titrated according to patient's saturation reaching to 90 ppb as a maximum dose
arm group label: Group A
intervention type: Device
intervention name: ventilators
description: All selected patients received conventional ventilation with protective lung strategy for 10 days with Controlled mechanical ventilation mode(CMV), fraction inspired oxygen (FIO2) of 100%, Positive end expiratory pressure(PEEP) of 10 cm H2O or more to achieve target arterial oxygen saturation(SPO2) of 90%
arm group label: Group A
arm group label: Group B
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
gender based: Yes
gender description: adult only
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Saudi Arabia
responsible party type: Sponsor
mesh term: Nitric Oxide
sharing ipd: No