<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/NCT03258684</url>
  </required_header>
  <id_info>
    <org_study_id>Liao Yuping</org_study_id>
    <nct_id>NCT03258684</nct_id>
  </id_info>
  <brief_title>Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Sepsis and Septic Shock</brief_title>
  <acronym>HYVCTTSSS</acronym>
  <official_title>Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Sepsis and Septic Shock: A Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhujiang Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zhujiang 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this prospective clinical study, the investigators compare the outcome and clinical course&#xD;
      of consecutive septic participants treated with intravenous vitamin C, hydrocortisone, and&#xD;
      thiamine (treatment group) with a control group treated in the investigators' ICU. The&#xD;
      primary outcome is hospital survival. A propensity score is generated to adjust the primary&#xD;
      outcome.There is 70 participants in each group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective randomized controlled trial is conducted.One hundred and forty severe sepsis or&#xD;
      septic shock participants admit to the Department of Critical Care Medicine of Zhujiang&#xD;
      Hospital,Southern Medical University from September 2017.The participants are divided into&#xD;
      control group ( n = 70 ) and treatment group ( n = 70 ).The participants in both groups are&#xD;
      treated according to &quot;2016 international guidelines for management of sepsis and septic&#xD;
      shock&quot;,and the participants in treatment group receive intravenous vitamin C, hydrocortisone,&#xD;
      and thiamine. The participants in control group receive normal saline.The patients' clinical&#xD;
      and demographic data, including age, sex, admitting diagnosis, comorbidities, requirement for&#xD;
      mechanical ventilation, use of vasopressors, daily urine output, fluid balance after 24 and&#xD;
      72 h, length of ICU stay (LOS),and laboratory data (serum creatinine, White Blood Cell (WBC),&#xD;
      platelet count, total bilirubin, procalcitonin(PCT), and lactate levels), are recorded.The&#xD;
      primary outcome is hospital survival. Secondary outcomes include duration of vasopressor&#xD;
      therapy,requirement for renal replacement therapy in patients with Acute kidney injury (AKI),&#xD;
      ICU LOS, and the change in serum procalcitonin and Sepsis-Related Organ Failure Assessment&#xD;
      (SOFA score) over the first 72 h. Summary statistics are used to describe the clinical data&#xD;
      and are presented as means±SD, medians and interquartile range, or percentages as&#xD;
      appropriate.Statistical analysis is performed with NCSS 11 (NCSS Statistical Software) and&#xD;
      SPSS Statistics version 24 (IBM).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 25, 2017</start_date>
  <completion_date type="Actual">February 2, 2019</completion_date>
  <primary_completion_date type="Actual">February 2, 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>
    <intervention_model_description>The participants in treatment group receive intravenous vitamin C, hydrocortisone, and thiamine. The participants in control group receive normal saline.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>hospital survival</measure>
    <time_frame>Up to Day 14</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>duration of vasopressor therapy</measure>
    <time_frame>Up to hour 72</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>requirement for renal replacement therapy in participants with Acute kidney injury(AKI)</measure>
    <time_frame>Up to Day 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU length of stay(LOS)</measure>
    <time_frame>Up to Day 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the change in serum procalcitonin (PCT)</measure>
    <time_frame>Up to hour 72</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sepsis-Related Organ Failure Assessment(SOFA)score</measure>
    <time_frame>Up to hour 96</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Sepsis</condition>
  <arm_group>
    <arm_group_label>vitamin C、hydrocortisone、thiamine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intravenous vitamin C (1.5 g every 6 h for 4 days or until ICU discharge), hydrocortisone (50 mg every 6 h for 7 days or until ICU discharge followed by a taper over 3 days), as well as intravenous thiamine (200 mg every 12 h for 4 days or until ICU discharge).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>normal saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Normal saline 500ml every day for 4 days，then 200ml every day for 3 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydrocortisone, Vitamin C, and Thiamine</intervention_name>
    <description>Intervention</description>
    <arm_group_label>vitamin C、hydrocortisone、thiamine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Normal saline</intervention_name>
    <description>Placebo</description>
    <arm_group_label>normal saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A primary diagnosis of sepsis or septic shock (the diagnoses of sepsis and septic&#xD;
             shock are based on the 2016 the Third International Consensus Definitions for Sepsis&#xD;
             and Septic Shock (Sepsis-3)) and a procalcitonin (PCT) level≥2ng/mL.&#xD;
&#xD;
        Sepsis: Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated&#xD;
        host response to infection.&#xD;
&#xD;
        Septic shock: Septic shock is a subset of sepsis in which underlying circulatory and&#xD;
        cellular/metabolic abnormalities are profound enough to substantially increase mortality.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients &lt; 18 years of age, pregnant patients, and patients with limitations of care.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510282</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>http://dx.doi.org/10.1016/j.chest.2016.11.036</url>
    <description>Related Info</description>
  </link>
  <reference>
    <citation>Marik PE, Khangoora V, Rivera R, Hooper MH, Catravas J. Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Severe Sepsis and Septic Shock: A Retrospective Before-After Study. Chest. 2017 Jun;151(6):1229-1238. doi: 10.1016/j.chest.2016.11.036. Epub 2016 Dec 6.</citation>
    <PMID>27940189</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>March 10, 2019</last_update_submitted>
  <last_update_submitted_qc>March 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>corticosteroid</keyword>
  <keyword>hydrocortisone</keyword>
  <keyword>septic shock</keyword>
  <keyword>thiamine</keyword>
  <keyword>vitamin C</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sepsis</mesh_term>
    <mesh_term>Toxemia</mesh_term>
    <mesh_term>Shock, Septic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thiamine</mesh_term>
    <mesh_term>Hydrocortisone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03258684
org study id: Liao Yuping
nct id: NCT03258684
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this prospective clinical study, the investigators compare the outcome and clinical course
      of consecutive septic participants treated with intravenous vitamin C, hydrocortisone, and
      thiamine (treatment group) with a control group treated in the investigators' ICU. The
      primary outcome is hospital survival. A propensity score is generated to adjust the primary
      outcome.There is 70 participants in each group.
A prospective randomized controlled trial is conducted.One hundred and forty severe sepsis or
      septic shock participants admit to the Department of Critical Care Medicine of Zhujiang
      Hospital,Southern Medical University from September 2017.The participants are divided into
      control group ( n = 70 ) and treatment group ( n = 70 ).The participants in both groups are
      treated according to "2016 international guidelines for management of sepsis and septic
      shock",and the participants in treatment group receive intravenous vitamin C, hydrocortisone,
      and thiamine. The participants in control group receive normal saline.The patients' clinical
      and demographic data, including age, sex, admitting diagnosis, comorbidities, requirement for
      mechanical ventilation, use of vasopressors, daily urine output, fluid balance after 24 and
      72 h, length of ICU stay (LOS),and laboratory data (serum creatinine, White Blood Cell (WBC),
      platelet count, total bilirubin, procalcitonin(PCT), and lactate levels), are recorded.The
      primary outcome is hospital survival. Secondary outcomes include duration of vasopressor
      therapy,requirement for renal replacement therapy in patients with Acute kidney injury (AKI),
      ICU LOS, and the change in serum procalcitonin and Sepsis-Related Organ Failure Assessment
      (SOFA score) over the first 72 h. Summary statistics are used to describe the clinical data
      and are presented as means±SD, medians and interquartile range, or percentages as
      appropriate.Statistical analysis is performed with NCSS 11 (NCSS Statistical Software) and
      SPSS Statistics version 24 (IBM).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The participants in treatment group receive intravenous vitamin C, hydrocortisone, and thiamine. The participants in control group receive normal saline.
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: hospital survival
time frame: Up to Day 14
measure: duration of vasopressor therapy
time frame: Up to hour 72
measure: requirement for renal replacement therapy in participants with Acute kidney injury(AKI)
time frame: Up to Day 14
measure: ICU length of stay(LOS)
time frame: Up to Day 14
measure: the change in serum procalcitonin (PCT)
time frame: Up to hour 72
measure: Sepsis-Related Organ Failure Assessment(SOFA)score
time frame: Up to hour 96
arm group label: vitamin C、hydrocortisone、thiamine
arm group type: Active Comparator
description: Intravenous vitamin C (1.5 g every 6 h for 4 days or until ICU discharge), hydrocortisone (50 mg every 6 h for 7 days or until ICU discharge followed by a taper over 3 days), as well as intravenous thiamine (200 mg every 12 h for 4 days or until ICU discharge).
arm group label: normal saline
arm group type: Placebo Comparator
description: Normal saline 500ml every day for 4 days，then 200ml every day for 3 days.
intervention type: Drug
intervention name: Hydrocortisone, Vitamin C, and Thiamine
description: Intervention
arm group label: vitamin C、hydrocortisone、thiamine
intervention type: Other
intervention name: Normal saline
description: Placebo
arm group label: normal saline
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: China
url: http://dx.doi.org/10.1016/j.chest.2016.11.036
description: Related Info
citation: Marik PE, Khangoora V, Rivera R, Hooper MH, Catravas J. Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Severe Sepsis and Septic Shock: A Retrospective Before-After Study. Chest. 2017 Jun;151(6):1229-1238. doi: 10.1016/j.chest.2016.11.036. Epub 2016 Dec 6.
PMID: 27940189
responsible party type: Sponsor
mesh term: Sepsis
mesh term: Toxemia
mesh term: Shock, Septic
mesh term: Thiamine
mesh term: Hydrocortisone
sharing ipd: Undecided