<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/NCT04446858</url>
  </required_header>
  <id_info>
    <org_study_id>NECTAR</org_study_id>
    <nct_id>NCT04446858</nct_id>
  </id_info>
  <brief_title>Non-invasive Evaluation of the Predictive Value of CEUS and SWE in ACLF, Renal Failure and Hepatorenal Syndrome</brief_title>
  <acronym>NECTAR</acronym>
  <official_title>Non-invasive Evaluation of the Predictive Value of CEUS and SWE in Patients With and Without TIPS With ACLF, Renal Failure and Hepatorenal Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Bonn</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Bonn</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>
      Evaluation of non-invasive prognostic parameters in patients developing ACLF and renal&#xD;
      failure in patients receiving and not receiving transjugular intrahepatic portosystemic shunt&#xD;
      (TIPS). Patients are cared according to the local standardized follow up program. Clinical&#xD;
      and laboratory data from standard patient care are evaluated for potential prognostic value.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      NECTAR consists of patients with ACLF and renal failure with and without receiving&#xD;
      transjugular intrahepatic portosystemic shunt (TIPS) at the Department of Internal Medicine&#xD;
      I, University of Bonn, Germany and receiving a structured routine evaluation and follow up&#xD;
      program. The diagnosis of cirrhosis was based on clinical, hemodynamic and biochemical&#xD;
      parameters, and ultrasound and/or biopsy criteria.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2021</start_date>
  <completion_date type="Anticipated">July 1, 2030</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2030</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>Survival</measure>
    <time_frame>up to 10 years</time_frame>
    <description>death, liver transplantation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ascites</measure>
    <time_frame>up to 10 years</time_frame>
    <description>Evaluation of amount of ascites according to the Child-Score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hepatic Encephalopathy</measure>
    <time_frame>up to 10 years</time_frame>
    <description>Evaluation of the grade according to the West Haven Criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variceal Bleeding</measure>
    <time_frame>up to 10 years</time_frame>
    <description>Assessment of presence of variceal bleeding</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Liver Failure</measure>
    <time_frame>up to 10 years</time_frame>
    <description>defined as Bilirubin level ≥ 12mg/dl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute-on-Chronic Liver Failure</measure>
    <time_frame>up to 10 years</time_frame>
    <description>Presence of ACLF according to the EASL-Chronic liver Failure Consortium (CLIF)-criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kidney Failure</measure>
    <time_frame>up to 10 years</time_frame>
    <description>Assessment of AKI according to KDIGO</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Organ Failures</measure>
    <time_frame>up to 10 years</time_frame>
    <description>Assessment of Organ failures according to CLIF-Sequential Organ Failure Assessment (SOFA) Score</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Kidney Failure, Acute</condition>
  <arm_group>
    <arm_group_label>With TIPS</arm_group_label>
    <description>Prospective cohort that received TIPS</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Without TIPS</arm_group_label>
    <description>Prospective cohort that did not receive TIPS</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      serum, plasma, urine, ascites, stool, DNA, PBMC, Buffi coat&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All patients with portal hypertension and kidney failure are eligible for inclusion&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients with portal hypertension and kidney failure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no consent, no kidney failure, no portal hypertension&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Praktiknjo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Bonn</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Michael Praktiknjo, MD</last_name>
    <phone>+49(0)228-287 15770</phone>
    <email>michael.praktiknjo@ukbonn.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Johannes Chang, MD</last_name>
    <phone>+49(0)228-287 15770</phone>
    <email>johannes.chang@ukbonn.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University Hospital Bonn</name>
      <address>
        <city>Bonn</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Praktiknjo, MD</last_name>
      <phone>+49228 28715770</phone>
      <email>michael.praktiknjo@ukbonn.de</email>
    </contact>
    <contact_backup>
      <last_name>Johannes Chang, MD</last_name>
      <phone>+49228 28715770</phone>
      <email>johannes.chang@ukbonn.de</email>
    </contact_backup>
    <investigator>
      <last_name>Nina Böhling, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>May 17, 2022</last_update_submitted>
  <last_update_submitted_qc>May 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Bonn</investigator_affiliation>
    <investigator_full_name>Michael Praktiknjo</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>transjugular intrahepatic portosystemic shunt (TIPS)</keyword>
  <keyword>non-invasive assessments</keyword>
  <keyword>circulating biomarkers</keyword>
  <keyword>Transthoracic echocardiography (TTE) with Speckle-tracking</keyword>
  <keyword>Elastography</keyword>
  <keyword>Contrast-enhanced ultrasound</keyword>
  <keyword>Computer tomography scan (CT-scan)</keyword>
  <keyword>Magnetic resonance imaging (MRI)</keyword>
  <keyword>Urine biomarker</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatorenal Syndrome</mesh_term>
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Acute Kidney Injury</mesh_term>
  </condition_browse>
  <!-- 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/NCT04446858
org study id: NECTAR
nct id: NCT04446858
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Evaluation of non-invasive prognostic parameters in patients developing ACLF and renal
      failure in patients receiving and not receiving transjugular intrahepatic portosystemic shunt
      (TIPS). Patients are cared according to the local standardized follow up program. Clinical
      and laboratory data from standard patient care are evaluated for potential prognostic value.
NECTAR consists of patients with ACLF and renal failure with and without receiving
      transjugular intrahepatic portosystemic shunt (TIPS) at the Department of Internal Medicine
      I, University of Bonn, Germany and receiving a structured routine evaluation and follow up
      program. The diagnosis of cirrhosis was based on clinical, hemodynamic and biochemical
      parameters, and ultrasound and/or biopsy criteria.
observational model: Cohort
time perspective: Prospective
measure: Survival
time frame: up to 10 years
description: death, liver transplantation
measure: Ascites
time frame: up to 10 years
description: Evaluation of amount of ascites according to the Child-Score
measure: Hepatic Encephalopathy
time frame: up to 10 years
description: Evaluation of the grade according to the West Haven Criteria
measure: Variceal Bleeding
time frame: up to 10 years
description: Assessment of presence of variceal bleeding
measure: Liver Failure
time frame: up to 10 years
description: defined as Bilirubin level ≥ 12mg/dl
measure: Acute-on-Chronic Liver Failure
time frame: up to 10 years
description: Presence of ACLF according to the EASL-Chronic liver Failure Consortium (CLIF)-criteria
measure: Kidney Failure
time frame: up to 10 years
description: Assessment of AKI according to KDIGO
measure: Organ Failures
time frame: up to 10 years
description: Assessment of Organ failures according to CLIF-Sequential Organ Failure Assessment (SOFA) Score
arm group label: With TIPS
description: Prospective cohort that received TIPS
arm group label: Without TIPS
description: Prospective cohort that did not receive TIPS
serum, plasma, urine, ascites, stool, DNA, PBMC, Buffi coat
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Michael Praktiknjo, MD
role: Principal Investigator
affiliation: University Hospital, Bonn
last name: Michael Praktiknjo, MD
phone: +49(0)228-287 15770
email: michael.praktiknjo@ukbonn.de
last name: Johannes Chang, MD
phone: +49(0)228-287 15770
email: johannes.chang@ukbonn.de
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Bonn
investigator full name: Michael Praktiknjo
investigator title: MD
mesh term: Hepatorenal Syndrome
mesh term: Renal Insufficiency
mesh term: Acute Kidney Injury