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/NCT06000748</url>
    </required_header>
    <id_info>
      <org_study_id>Pending</org_study_id>
      <nct_id>NCT06000748</nct_id>
    </id_info>
    <brief_title>NEPH-ROSIS (NEPHrology in CirRhOSIS) Pilot Trial: A Trial to Treat Acute Kidney Injury Among Hospitalized Cirrhosis Patients</brief_title>
    <acronym>NEPH-ROSIS</acronym>
    <official_title>NEPH-ROSIS (NEPHrology in CirRhOSIS) Pilot Trial: A Trial to Treat Acute Kidney Injury Among Hospitalized Cirrhosis Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of California, San Francisco</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of California, San Francisco</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>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this pilot, randomized, single-blind clinical trial is to estimate the effect&#xD;
        size of a high and low mean arterial pressure (MAP)-target algorithm among cirrhosis patients&#xD;
        hospitalized with acute kidney injury. The main aims to answer are: • Does an algorithm that&#xD;
        has low (&lt;80 mmHg) and high (≥80) MAP-targets lead to significant differences in mean&#xD;
        arterial pressure? • Are there any serious adverse events (e.g., ischemia) in a high blood&#xD;
        pressure algorithm as compared to a low blood pressure algorithm? • Are there any differences&#xD;
        in the incidence of AKI reversal in the high v. low MAP-target groups? Participants will be:&#xD;
        1) Randomized to a clinical algorithm that will either target a low (&lt;80 mmHg) or high (≥80&#xD;
        mmHg) MAP. 2) Depending on their group, investigators will titrate commonly used medications&#xD;
        to a specific MAP target. Researchers will compare the high and low MAP-target groups to see&#xD;
        if these algorithms lead to significant changes in MAP, if they have any impact on AKI&#xD;
        reversal, and if there are any adverse events in the high MAP-target group.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">February 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 1, 2024</primary_completion_date>
    <phase>Phase 2/Phase 3</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>This is a single-blind, randomized control, parallel-group, pragmatic trial.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
      <masking_description>This is single blind. The participants will be blinded to their intervention arm. The treating providers will not be blinded as they will receive either the low or high MAP-target treatment algorithm.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Differences in mean arterial pressure.</measure>
      <time_frame>14 days.</time_frame>
      <description>The investigators will determine if a high, as compared to a low, MAP-target algorithm leads to significantly different changes in MAP. This will be completed by comparing the change in MAP from the baseline to the completion of the study.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Acute kidney injury reversal.</measure>
      <time_frame>14 days</time_frame>
      <description>The investigators will determine if a high, as compared to a low, MAP-target algorithm leads to significantly different incidences of acute kidney injury reversal. This will be defined as a decrease in serum creatinine (sCr) to within 0.3 mg/dL of the baseline sCr.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">25</enrollment>
    <condition>Acute Kidney Injury</condition>
    <condition>Cirrhosis</condition>
    <condition>Portal Hypertension</condition>
    <condition>Hepatorenal Syndrome</condition>
    <condition>Acute Tubule Necrosis</condition>
    <condition>Prerenal Failure</condition>
    <arm_group>
      <arm_group_label>Low MAP-Target</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>This group will be randomized to a treatment algorithm that utilizes a low MAP-target (&lt;80 mmHg) to determine if titration of vasoconstrictors is needed.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>High MAP-Target</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>This group will be randomized to a treatment algorithm that utilizes a high MAP-target (≥80 mmHg) to determine if titration of vasoconstrictors is needed.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>MAP-Target Algorithm</intervention_name>
      <description>This is a clinical treatment algorithm that will determine the escalation and deescalation of vasoconstrictor utilization based on a target MAP, either high (≥80 mmHg) in the treatment group and low (&lt; 80 mmHg) in the comparator group.</description>
      <arm_group_label>High MAP-Target</arm_group_label>
      <arm_group_label>Low MAP-Target</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Hospitalized patients with decompensated cirrhosis, defined as a Child-Pugh Score ≥ 7&#xD;
  &#xD;
            -  Acute Kidney Injury: a ≥50% increase in sCr from an outpatient baseline sCr measured 7&#xD;
               to 365 days prior to admission&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients without a baseline (7 - 365 days prior to AKI development) sCr measurement;&#xD;
  &#xD;
            2. Patients who are already on kidney replacement therapy (KRT) at the time of&#xD;
               enrollment;&#xD;
  &#xD;
            3. Patients with an oxygen requirement greater than 6L via nasal cannula;&#xD;
  &#xD;
            4. Patients with a serum creatinine level exceeding 5 mg/dL.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Participant eligibility is based on self-representation of gender identity.</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Giuseppe Cullaro, MD, MAS</last_name>
      <phone>415 476 3143</phone>
      <email>giuseppe.cullaro@ucsf.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Hannah Chao, BS</last_name>
      <phone>415 476 3143</phone>
      <email>hannah.chao@ucsf.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of California San Francisco</name>
        <address>
          <city>San Francisco</city>
          <state>California</state>
          <zip>94143</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>PRAGMATIC</keyword>
    <keyword>FEASIBILITY</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Liver Cirrhosis</mesh_term>
      <mesh_term>Hypertension, Portal</mesh_term>
      <mesh_term>Hepatorenal Syndrome</mesh_term>
      <mesh_term>Acute Kidney Injury</mesh_term>
      <mesh_term>Kidney Tubular Necrosis, Acute</mesh_term>
      <mesh_term>Fibrosis</mesh_term>
      <mesh_term>Necrosis</mesh_term>
      <mesh_term>Wounds and Injuries</mesh_term>
    </condition_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/NCT06000748
  org study id: Pending
  nct id: NCT06000748
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  The goal of this pilot, randomized, single-blind clinical trial is to estimate the effect
        size of a high and low mean arterial pressure (MAP)-target algorithm among cirrhosis patients
        hospitalized with acute kidney injury. The main aims to answer are: • Does an algorithm that
        has low (<80 mmHg) and high (≥80) MAP-targets lead to significant differences in mean
        arterial pressure? • Are there any serious adverse events (e.g., ischemia) in a high blood
        pressure algorithm as compared to a low blood pressure algorithm? • Are there any differences
        in the incidence of AKI reversal in the high v. low MAP-target groups? Participants will be:
        1) Randomized to a clinical algorithm that will either target a low (<80 mmHg) or high (≥80
        mmHg) MAP. 2) Depending on their group, investigators will titrate commonly used medications
        to a specific MAP target. Researchers will compare the high and low MAP-target groups to see
        if these algorithms lead to significant changes in MAP, if they have any impact on AKI
        reversal, and if there are any adverse events in the high MAP-target group.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This is a single-blind, randomized control, parallel-group, pragmatic trial.
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  masking description: This is single blind. The participants will be blinded to their intervention arm. The treating providers will not be blinded as they will receive either the low or high MAP-target treatment algorithm.
  measure: Differences in mean arterial pressure.
  time frame: 14 days.
  description: The investigators will determine if a high, as compared to a low, MAP-target algorithm leads to significantly different changes in MAP. This will be completed by comparing the change in MAP from the baseline to the completion of the study.
  measure: Acute kidney injury reversal.
  time frame: 14 days
  description: The investigators will determine if a high, as compared to a low, MAP-target algorithm leads to significantly different incidences of acute kidney injury reversal. This will be defined as a decrease in serum creatinine (sCr) to within 0.3 mg/dL of the baseline sCr.
  arm group label: Low MAP-Target
  arm group type: Active Comparator
  description: This group will be randomized to a treatment algorithm that utilizes a low MAP-target (<80 mmHg) to determine if titration of vasoconstrictors is needed.
  arm group label: High MAP-Target
  arm group type: Active Comparator
  description: This group will be randomized to a treatment algorithm that utilizes a high MAP-target (≥80 mmHg) to determine if titration of vasoconstrictors is needed.
  intervention type: Drug
  intervention name: MAP-Target Algorithm
  description: This is a clinical treatment algorithm that will determine the escalation and deescalation of vasoconstrictor utilization based on a target MAP, either high (≥80 mmHg) in the treatment group and low (< 80 mmHg) in the comparator group.
  arm group label: High MAP-Target
  arm group label: Low MAP-Target
  criteria: 
  gender: All
  gender based: Yes
  gender description: Participant eligibility is based on self-representation of gender identity.
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Giuseppe Cullaro, MD, MAS
  phone: 415 476 3143
  email: giuseppe.cullaro@ucsf.edu
  last name: Hannah Chao, BS
  phone: 415 476 3143
  email: hannah.chao@ucsf.edu
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Liver Cirrhosis
  mesh term: Hypertension, Portal
  mesh term: Hepatorenal Syndrome
  mesh term: Acute Kidney Injury
  mesh term: Kidney Tubular Necrosis, Acute
  mesh term: Fibrosis
  mesh term: Necrosis
  mesh term: Wounds and Injuries
  sharing ipd: No