xml: <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/NCT06008223</url>
    </required_header>
    <id_info>
      <org_study_id>HHuzhou 001</org_study_id>
      <nct_id>NCT06008223</nct_id>
    </id_info>
    <brief_title>Clinical Analysis of Vitamin B6 in Sepsis</brief_title>
    <official_title>Renal Protective Effect and Clinical Analysis of Vitamin B6 in Patients With Sepsis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The First People's Hospital of Huzhou</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The First People's Hospital of Huzhou</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>
        Methodology Patients A total of 128 patients with sepsis and AKI who were admitted to several&#xD;
        centers including Huzhou first people's Hospital combined with Wuxing People's Hospital,&#xD;
        Linghu people's Hospital and Nanxun people's Hospital from November 1, 2021 to October 31,&#xD;
        2022 were included in the study. And all patients were diagnosed by clinical examination,&#xD;
        Diagnostic criteria sepsis was diagnosed according to the international Sepsis-3 for patients&#xD;
        with suspected infection using the quickly Sepsis related organ failure assessment (qSOFA).&#xD;
        The qSOFA score consists of only three criteria: Glasgow Coma Scale (GCS) &lt;15, systolic blood&#xD;
        pressure ≤ 100 mmHg, and respiratory rate ≥22/min. A qSOFA score of 2 or more points&#xD;
        indicates suspected sepsis. Criteria for AKI was defined according to the Kidney Disease&#xD;
        Improving Global Outcomes (KDIGO), by the presence of one of the following: ①Increase in SCr&#xD;
        by ≥ 0.3mg/dl (≥26.5 μ mol/L) within 48h；② Renal impairment is known or increase in SCr by&#xD;
        ≥50% within 7days; ③ Oliguria for ≥4 hours.&#xD;
  &#xD;
        All patients were authorized by their families to sign informed consent, and the study was&#xD;
        approved by the ethics committee of the hospital.&#xD;
  &#xD;
        Inclusion criteria: ①18-65 years old; ② The hospital survival time was more than 48 hours,&#xD;
        and the medical records were complete; ③There is no history of vitamin B6 use in the recent&#xD;
        period of admission (within 2 weeks before admission).&#xD;
  &#xD;
        Exclusion criteria: ①Patients with chronic renal insufficiency or renal failure in the past;&#xD;
        ②Related renal injury caused by reasons other than sepsis; ③At the time of admission to ICU,&#xD;
        there was cardiac failure or cardiogenic shock in combination with sepsis; ④Patients who use&#xD;
        nephrotoxic drugs or contrast agents; ⑤Previous kidney transplantation; ⑥Patients with&#xD;
        restrictive use of positive inotropic drugs (such as left ventricular outflow tract&#xD;
        stenosis); ⑦Age&lt;18 or&gt;65; ⑧pregnant woman.&#xD;
  &#xD;
        Treatment 128 patients were divided into experimental and control group by random number&#xD;
        table method, 64 patients in each group. Both groups were given routine treatment of sepsis&#xD;
        and corresponding treatment of primary disease. The Patients in experimental group were given&#xD;
        vitamin B6 injection 300mg/d (100mg/2ml× 3) intravenous injection, the course of treatment is&#xD;
        one week or until the patient dies. That in control group were injected with 0.9% sodium&#xD;
        chloride solution 6 ml intravenously.&#xD;
  &#xD;
        Assessment The general clinical data of the two groups were recorded, including age, sex,&#xD;
        acute physiology and chronic health status scoring system II (APACHE II), qSOFA, and the&#xD;
        constituent ratio of primary disease before treatment.&#xD;
  &#xD;
        The inflammatory reaction indexes of the two groups were detected before and on the 7th day&#xD;
        of treatment, including Interleukin 6 (IL-6), interleukin 8 (IL-8), tumor necrosis factor&#xD;
        (TNF-α) and endothelin-1 (ET-1). After collecting 5ml of fasting elbow vein blood from two&#xD;
        groups of patients, the serum was separated by centrifugation (centrifugation radius: 3cm,&#xD;
        rotation speed: 2000r/min, time: 10min), and then detected by enzyme-linked immunosorbent&#xD;
        assay (ELISA). ELISA kits for IL-6 (ab178013), IL-8 (ab214030), and TNF-a(ab181241) were&#xD;
        purchased from abcam company. ELISA kit for ET-1 (K7429-100) was purchased from BioVision.&#xD;
        All ELISA experiments were performed according to the kit instructions.&#xD;
  &#xD;
        The oxidative stress response indexs of the two groups were detected before and on the 7th&#xD;
        day of treatment, including superoxide dismutase (SOD), glutathione (GSH), malondialdehyde&#xD;
        (MDA). The xanthine oxidase method is used to detect SOD, the DTNB method is used to detect&#xD;
        GSH, and the thiobarbituric acid method is used to detect MDA.&#xD;
  &#xD;
        The renal function indexs before and after treatment were detected before and on the 7th day&#xD;
        of treatment, including the blood urea nitrogen (BUN) and serum creatinine (sCr) and renal&#xD;
        resistance index (RRI). RRI was detected by ultrasound.&#xD;
  &#xD;
        And the clinical data, including the rate of renal replacement therapy, ICU length of stay,&#xD;
        total hospitalization expenses, and 28-d mortality, were recorded.&#xD;
  &#xD;
        Statistical analysis All measurements were expressed as mean ± standard deviation (x ± s).&#xD;
        And the counting datas were expressed in the form of percentage [n (%)]. The statistical SPSS&#xD;
        23.0 software were performed using the two samples t-test and adjusted chi-square test for&#xD;
        the two groups. P-value,0.05 was considered to be statistically significant.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">November 1, 2021</start_date>
    <completion_date type="Actual">November 30, 2022</completion_date>
    <primary_completion_date type="Actual">October 31, 2022</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 (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Inflammatory response index</measure>
      <time_frame>before treatment</time_frame>
      <description>The inflammatory reaction indexes of the two groups were detected . After collecting 5ml of fasting elbow vein blood from two groups of patients, the serum was separated by centrifugation (centrifugation radius: 3cm, rotation speed: 2000r/min, time: 10min), and then detected by enzyme-linked immunosorbent assay (ELISA).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Inflammatory response index</measure>
      <time_frame>on the 7th day of treatment</time_frame>
      <description>The inflammatory reaction indexes of the two groups were detected . After collecting 5ml of fasting elbow vein blood from two groups of patients, the serum was separated by centrifugation (centrifugation radius: 3cm, rotation speed: 2000r/min, time: 10min), and then detected by enzyme-linked immunosorbent assay (ELISA).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Oxidative stress response index</measure>
      <time_frame>before treatment</time_frame>
      <description>The oxidative stress response indexs of the two groups were detected. The xanthine oxidase method is used to detect SOD, the DTNB method is used to detect GSH, and the thiobarbituric acid method is used to detect MDA.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Oxidative stress response index</measure>
      <time_frame>on the 7th day of treatment</time_frame>
      <description>The oxidative stress response indexs of the two groups were detected. The xanthine oxidase method is used to detect SOD, the DTNB method is used to detect GSH, and the thiobarbituric acid method is used to detect MDA.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Renal function index</measure>
      <time_frame>before of treatment</time_frame>
      <description>The renal function indexs before treatment were detected before the 7th day of treatment.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Renal function index</measure>
      <time_frame>on the 7th day of treatment</time_frame>
      <description>The renal function indexs after treatment were detected on the 7th day of treatment.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">128</enrollment>
    <condition>Sepsis</condition>
    <condition>Vitamin B6</condition>
    <condition>Kidney Injury</condition>
    <condition>Inflammatory Response</condition>
    <condition>Oxidative Stress Response</condition>
    <arm_group>
      <arm_group_label>experimental group (vitamin B6)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>control group (0.9% sodium chloride solution)</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>vitamin B6</intervention_name>
      <description>The Patients in experimental group were given vitamin B6 injection 300mg/d (100mg/2ml× 3) intravenous injection.</description>
      <arm_group_label>experimental group (vitamin B6)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>0.9% sodium chloride solution</intervention_name>
      <description>That in control group were injected with 0.9% sodium chloride solution 6 ml intravenously.</description>
      <arm_group_label>control group (0.9% sodium chloride solution)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18-65 years old;&#xD;
  &#xD;
            -  The hospital survival time was more than 48 hours, and the medical records were&#xD;
               complete;&#xD;
  &#xD;
            -  There is no history of vitamin B6 use in the recent period of admission (within 2&#xD;
               weeks before admission).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with chronic renal insufficiency or renal failure in the past;&#xD;
  &#xD;
            -  Related renal injury caused by reasons other than sepsis;&#xD;
  &#xD;
            -  At the time of admission to ICU, there was cardiac failure or cardiogenic shock in&#xD;
               combination with sepsis;&#xD;
  &#xD;
            -  Patients who use nephrotoxic drugs or contrast agents;&#xD;
  &#xD;
            -  Previous kidney transplantation;&#xD;
  &#xD;
            -  Patients with restrictive use of positive inotropic drugs (such as left ventricular&#xD;
               outflow tract stenosis);&#xD;
  &#xD;
            -  Age&lt;18 or&gt;65;&#xD;
  &#xD;
            -  pregnant woman.&#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>Wen-Ming Feng</name>
        <address>
          <city>Huzhou</city>
          <state>Zhejiang</state>
          <zip>313000</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The First People's Hospital of Huzhou</investigator_affiliation>
      <investigator_full_name>Wen-Ming Feng</investigator_full_name>
      <investigator_title>Principal investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sepsis</mesh_term>
      <mesh_term>Toxemia</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vitamin B 6</mesh_term>
      <mesh_term>Pyridoxal</mesh_term>
      <mesh_term>Pyridoxine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06008223
  org study id: HHuzhou 001
  nct id: NCT06008223
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Methodology Patients A total of 128 patients with sepsis and AKI who were admitted to several
        centers including Huzhou first people's Hospital combined with Wuxing People's Hospital,
        Linghu people's Hospital and Nanxun people's Hospital from November 1, 2021 to October 31,
        2022 were included in the study. And all patients were diagnosed by clinical examination,
        Diagnostic criteria sepsis was diagnosed according to the international Sepsis-3 for patients
        with suspected infection using the quickly Sepsis related organ failure assessment (qSOFA).
        The qSOFA score consists of only three criteria: Glasgow Coma Scale (GCS) <15, systolic blood
        pressure ≤ 100 mmHg, and respiratory rate ≥22/min. A qSOFA score of 2 or more points
        indicates suspected sepsis. Criteria for AKI was defined according to the Kidney Disease
        Improving Global Outcomes (KDIGO), by the presence of one of the following: ①Increase in SCr
        by ≥ 0.3mg/dl (≥26.5 μ mol/L) within 48h；② Renal impairment is known or increase in SCr by
        ≥50% within 7days; ③ Oliguria for ≥4 hours.
  
        All patients were authorized by their families to sign informed consent, and the study was
        approved by the ethics committee of the hospital.
  
        Inclusion criteria: ①18-65 years old; ② The hospital survival time was more than 48 hours,
        and the medical records were complete; ③There is no history of vitamin B6 use in the recent
        period of admission (within 2 weeks before admission).
  
        Exclusion criteria: ①Patients with chronic renal insufficiency or renal failure in the past;
        ②Related renal injury caused by reasons other than sepsis; ③At the time of admission to ICU,
        there was cardiac failure or cardiogenic shock in combination with sepsis; ④Patients who use
        nephrotoxic drugs or contrast agents; ⑤Previous kidney transplantation; ⑥Patients with
        restrictive use of positive inotropic drugs (such as left ventricular outflow tract
        stenosis); ⑦Age<18 or>65; ⑧pregnant woman.
  
        Treatment 128 patients were divided into experimental and control group by random number
        table method, 64 patients in each group. Both groups were given routine treatment of sepsis
        and corresponding treatment of primary disease. The Patients in experimental group were given
        vitamin B6 injection 300mg/d (100mg/2ml× 3) intravenous injection, the course of treatment is
        one week or until the patient dies. That in control group were injected with 0.9% sodium
        chloride solution 6 ml intravenously.
  
        Assessment The general clinical data of the two groups were recorded, including age, sex,
        acute physiology and chronic health status scoring system II (APACHE II), qSOFA, and the
        constituent ratio of primary disease before treatment.
  
        The inflammatory reaction indexes of the two groups were detected before and on the 7th day
        of treatment, including Interleukin 6 (IL-6), interleukin 8 (IL-8), tumor necrosis factor
        (TNF-α) and endothelin-1 (ET-1). After collecting 5ml of fasting elbow vein blood from two
        groups of patients, the serum was separated by centrifugation (centrifugation radius: 3cm,
        rotation speed: 2000r/min, time: 10min), and then detected by enzyme-linked immunosorbent
        assay (ELISA). ELISA kits for IL-6 (ab178013), IL-8 (ab214030), and TNF-a(ab181241) were
        purchased from abcam company. ELISA kit for ET-1 (K7429-100) was purchased from BioVision.
        All ELISA experiments were performed according to the kit instructions.
  
        The oxidative stress response indexs of the two groups were detected before and on the 7th
        day of treatment, including superoxide dismutase (SOD), glutathione (GSH), malondialdehyde
        (MDA). The xanthine oxidase method is used to detect SOD, the DTNB method is used to detect
        GSH, and the thiobarbituric acid method is used to detect MDA.
  
        The renal function indexs before and after treatment were detected before and on the 7th day
        of treatment, including the blood urea nitrogen (BUN) and serum creatinine (sCr) and renal
        resistance index (RRI). RRI was detected by ultrasound.
  
        And the clinical data, including the rate of renal replacement therapy, ICU length of stay,
        total hospitalization expenses, and 28-d mortality, were recorded.
  
        Statistical analysis All measurements were expressed as mean ± standard deviation (x ± s).
        And the counting datas were expressed in the form of percentage [n (%)]. The statistical SPSS
        23.0 software were performed using the two samples t-test and adjusted chi-square test for
        the two groups. P-value,0.05 was considered to be statistically significant.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Inflammatory response index
  time frame: before treatment
  description: The inflammatory reaction indexes of the two groups were detected . After collecting 5ml of fasting elbow vein blood from two groups of patients, the serum was separated by centrifugation (centrifugation radius: 3cm, rotation speed: 2000r/min, time: 10min), and then detected by enzyme-linked immunosorbent assay (ELISA).
  measure: Inflammatory response index
  time frame: on the 7th day of treatment
  description: The inflammatory reaction indexes of the two groups were detected . After collecting 5ml of fasting elbow vein blood from two groups of patients, the serum was separated by centrifugation (centrifugation radius: 3cm, rotation speed: 2000r/min, time: 10min), and then detected by enzyme-linked immunosorbent assay (ELISA).
  measure: Oxidative stress response index
  time frame: before treatment
  description: The oxidative stress response indexs of the two groups were detected. The xanthine oxidase method is used to detect SOD, the DTNB method is used to detect GSH, and the thiobarbituric acid method is used to detect MDA.
  measure: Oxidative stress response index
  time frame: on the 7th day of treatment
  description: The oxidative stress response indexs of the two groups were detected. The xanthine oxidase method is used to detect SOD, the DTNB method is used to detect GSH, and the thiobarbituric acid method is used to detect MDA.
  measure: Renal function index
  time frame: before of treatment
  description: The renal function indexs before treatment were detected before the 7th day of treatment.
  measure: Renal function index
  time frame: on the 7th day of treatment
  description: The renal function indexs after treatment were detected on the 7th day of treatment.
  arm group label: experimental group (vitamin B6)
  arm group type: Experimental
  arm group label: control group (0.9% sodium chloride solution)
  arm group type: Placebo Comparator
  intervention type: Drug
  intervention name: vitamin B6
  description: The Patients in experimental group were given vitamin B6 injection 300mg/d (100mg/2ml× 3) intravenous injection.
  arm group label: experimental group (vitamin B6)
  intervention type: Drug
  intervention name: 0.9% sodium chloride solution
  description: That in control group were injected with 0.9% sodium chloride solution 6 ml intravenously.
  arm group label: control group (0.9% sodium chloride solution)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: The First People's Hospital of Huzhou
  investigator full name: Wen-Ming Feng
  investigator title: Principal investigator
  mesh term: Sepsis
  mesh term: Toxemia
  mesh term: Vitamin B 6
  mesh term: Pyridoxal
  mesh term: Pyridoxine
  sharing ipd: No