<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/NCT04467892</url>
  </required_header>
  <id_info>
    <org_study_id>ICU-11-20</org_study_id>
    <nct_id>NCT04467892</nct_id>
  </id_info>
  <brief_title>Low Versus High Corticosteroid Use in Ventilator Associated Pneumonia</brief_title>
  <official_title>Comparative Study Between the Uses of High Dose Corticosteroid Therapy for Short Duration Versus Low Dose Corticosteroid for Long Duration in Severe Lung Contusion With 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>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      patients who had &gt;3 on Murray score and &gt;6 on CPIS allocated randomly in two groups 120&#xD;
      patients in each. Group A received 30 mg/kg methyl-prednisolone slowly intravenous in 250 mL&#xD;
      normal saline every 8 hours for only 48 hours while group B received 1 mg/kg/day&#xD;
      methyl-prednisolone divided to three doses given every 8 hours for two weeks. Duration of the&#xD;
      study last 16 days, Morbidity considered if no improvement in any or all clinical parameters&#xD;
      of both Murray and CPIS scores and failure of weaning of patients from the ventilator at the&#xD;
      studied period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adult patients aged &gt;18&lt;65 years, hypercapnia with PH &lt;7.25, hypoxic index less than 200&#xD;
      (PaO2/FIO2), bilateral parenchymatous lung infiltration in the chest Xray. All selected&#xD;
      patients received conventional ventilation with protective lung strategy for 3 days with&#xD;
      Controlled mechanical ventilation mode (CMV), fraction inspired oxygen (FIO2) of 100%,&#xD;
      Positive end expiratory pressure (PEEP) adjusted to achieve target arterial oxygen saturation&#xD;
      (SPO2) of &gt;90%. Sedation and pain control done by both midazolam and fentanyl infusion to&#xD;
      achieve Richmond Agitation- Sedation Scale (RASS) -2. Protective lung strategy applied and&#xD;
      include, head elevation more than 45-degree, daily assessment for both analgesic and sedative&#xD;
      dose, early naso-gastric feeding to prevent bacterial translocation and flooding of the blood&#xD;
      with gram negative septicemia, usage of the minimal PEEP to maintain SPO2 &gt;90%. Qualitative&#xD;
      sputum culture was taken after 3 days from ventilation. After 3 days from the conventional&#xD;
      ventilation only 240 patients enrolled in our study. Those who had a Murray score (for&#xD;
      diagnosis of ARDS) of &gt;3 and CPIS (clinical pulmonary infection score) (for diagnosis of VAP)&#xD;
      &gt; 6. All patients were randomly allocated in 2 groups 120 patients in each. All patients&#xD;
      received intravenous antibiotics meropenem 1 gm slowly intravenous every 8 hours for the&#xD;
      first 8 days then antibiotics was given according to sputum culture and antibiotics&#xD;
      sensitivity. Group A received high dose (30 mg/kg) methylprednisolone slowly intravenous in&#xD;
      250 ml normal saline every 8 hours for only 4 days while group B included received 1&#xD;
      mg/kg/day methylprednisolone divided to three doses given every 8 hours for two weeks. This&#xD;
      study conducted for 16 days.&#xD;
&#xD;
      VAP diagnosed in our study by CPIS 6 or more while severity of lung contusion assessed by&#xD;
      Murray score 3 or more&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2, 2018</start_date>
  <completion_date type="Actual">February 25, 2020</completion_date>
  <primary_completion_date type="Actual">February 14, 2020</primary_completion_date>
  <phase>Phase 2</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>
    <intervention_model_description>Patients who had severe chest trauma with massive lung contusion and admitted to King Abdelaziz specialist hospital between January 2018 and February 2020 in the intensive care unit those who showed the following inclusion criteria of ARDS, respiratory failure due to severe lung contusion complicated by VAP enrolled in our study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>patients with COPD respiratory failure, patients with congestive heart failure</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients weaned from the ventilators</measure>
    <time_frame>2 weeks</time_frame>
    <description>followed by arterial oxygen saturation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients discharge from ICU</measure>
    <time_frame>2 weeks</time_frame>
    <description>number of patients weaned and ready to be discharged from ICU</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">240</enrollment>
  <condition>Ventilator Associated Pneumonia</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>. Group A 120 patients, received high dose (30 mg/kg) methylprednisolone slowly intravenous in 250 ml normal saline every 8 hours for only 4 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>group B 120 patients, included received 1 mg/kg/day methylprednisolone divided to three doses given every 8 hours for two weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>methylprednisolone</intervention_name>
    <description>received high dose (30 mg/kg) methylprednisolone slowly intravenous in 250 ml normal saline every 8 hours for only 4 days</description>
    <arm_group_label>Group A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methyl Prednisolonate</intervention_name>
    <description>received 1 mg/kg/day methylprednisolone divided to three doses given every 8 hours for two weeks.</description>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ventilators</intervention_name>
    <description>all patients in both groups will be ventilated with CMV for 2 weeks</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ventilator associated pneumonia patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  post cardiac arrest&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <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>July 2020</verification_date>
  <study_first_submitted>June 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>July 8, 2020</last_update_submitted>
  <last_update_submitted_qc>July 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Pneumonia, Ventilator-Associated</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methylprednisolone</mesh_term>
    <mesh_term>Methylprednisolone Acetate</mesh_term>
    <mesh_term>Methylprednisolone Hemisuccinate</mesh_term>
    <mesh_term>Prednisolone</mesh_term>
    <mesh_term>Prednisolone acetate</mesh_term>
    <mesh_term>Prednisolone hemisuccinate</mesh_term>
    <mesh_term>Prednisolone phosphate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>medical doctors and intensivist</ipd_description>
  </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/NCT04467892
org study id: ICU-11-20
nct id: NCT04467892
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
patients who had >3 on Murray score and >6 on CPIS allocated randomly in two groups 120
      patients in each. Group A received 30 mg/kg methyl-prednisolone slowly intravenous in 250 mL
      normal saline every 8 hours for only 48 hours while group B received 1 mg/kg/day
      methyl-prednisolone divided to three doses given every 8 hours for two weeks. Duration of the
      study last 16 days, Morbidity considered if no improvement in any or all clinical parameters
      of both Murray and CPIS scores and failure of weaning of patients from the ventilator at the
      studied period.
Adult patients aged >18<65 years, hypercapnia with PH <7.25, hypoxic index less than 200
      (PaO2/FIO2), bilateral parenchymatous lung infiltration in the chest Xray. All selected
      patients received conventional ventilation with protective lung strategy for 3 days with
      Controlled mechanical ventilation mode (CMV), fraction inspired oxygen (FIO2) of 100%,
      Positive end expiratory pressure (PEEP) adjusted to achieve target arterial oxygen saturation
      (SPO2) of >90%. Sedation and pain control done by both midazolam and fentanyl infusion to
      achieve Richmond Agitation- Sedation Scale (RASS) -2. Protective lung strategy applied and
      include, head elevation more than 45-degree, daily assessment for both analgesic and sedative
      dose, early naso-gastric feeding to prevent bacterial translocation and flooding of the blood
      with gram negative septicemia, usage of the minimal PEEP to maintain SPO2 >90%. Qualitative
      sputum culture was taken after 3 days from ventilation. After 3 days from the conventional
      ventilation only 240 patients enrolled in our study. Those who had a Murray score (for
      diagnosis of ARDS) of >3 and CPIS (clinical pulmonary infection score) (for diagnosis of VAP)
      > 6. All patients were randomly allocated in 2 groups 120 patients in each. All patients
      received intravenous antibiotics meropenem 1 gm slowly intravenous every 8 hours for the
      first 8 days then antibiotics was given according to sputum culture and antibiotics
      sensitivity. Group A received high dose (30 mg/kg) methylprednisolone slowly intravenous in
      250 ml normal saline every 8 hours for only 4 days while group B included received 1
      mg/kg/day methylprednisolone divided to three doses given every 8 hours for two weeks. This
      study conducted for 16 days.

      VAP diagnosed in our study by CPIS 6 or more while severity of lung contusion assessed by
      Murray score 3 or more
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients who had severe chest trauma with massive lung contusion and admitted to King Abdelaziz specialist hospital between January 2018 and February 2020 in the intensive care unit those who showed the following inclusion criteria of ARDS, respiratory failure due to severe lung contusion complicated by VAP enrolled in our study
primary purpose: Treatment
masking: None (Open Label)
masking description: patients with COPD respiratory failure, patients with congestive heart failure
measure: Number of patients weaned from the ventilators
time frame: 2 weeks
description: followed by arterial oxygen saturation
measure: Number of patients discharge from ICU
time frame: 2 weeks
description: number of patients weaned and ready to be discharged from ICU
arm group label: Group A
arm group type: Active Comparator
description: . Group A 120 patients, received high dose (30 mg/kg) methylprednisolone slowly intravenous in 250 ml normal saline every 8 hours for only 4 days
arm group label: Group B
arm group type: Active Comparator
description: group B 120 patients, included received 1 mg/kg/day methylprednisolone divided to three doses given every 8 hours for two weeks.
intervention type: Drug
intervention name: methylprednisolone
description: received high dose (30 mg/kg) methylprednisolone slowly intravenous in 250 ml normal saline every 8 hours for only 4 days
arm group label: Group A
intervention type: Drug
intervention name: Methyl Prednisolonate
description: received 1 mg/kg/day methylprednisolone divided to three doses given every 8 hours for two weeks.
arm group label: Group B
intervention type: Device
intervention name: ventilators
description: all patients in both groups will be ventilated with CMV for 2 weeks
arm group label: Group A
arm group label: Group B
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Saudi Arabia
responsible party type: Sponsor
mesh term: Pneumonia
mesh term: Pneumonia, Ventilator-Associated
mesh term: Methylprednisolone
mesh term: Methylprednisolone Acetate
mesh term: Methylprednisolone Hemisuccinate
mesh term: Prednisolone
mesh term: Prednisolone acetate
mesh term: Prednisolone hemisuccinate
mesh term: Prednisolone phosphate
sharing ipd: No
ipd description: medical doctors and intensivist