<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/NCT02261909</url>
  </required_header>
  <id_info>
    <org_study_id>1</org_study_id>
    <nct_id>NCT02261909</nct_id>
  </id_info>
  <brief_title>New Prognostic Kidney Function Markers in Emergency Patients New Markers of Kidney Function in ED Patients</brief_title>
  <official_title>New Prognostic Kidney Function Markers in Emergency Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Krankenhaus Barmherzige Brüder, Regensburg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Astute Medical, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Krankenhaus Barmherzige Brüder, Regensburg</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      NephroCheck is measuring the concentration of a certain protein combination in the urine of&#xD;
      patients. In elevated values there is a probability of renal failure (already proven in&#xD;
      intensive care patients). The investigators would like to investigate whether the&#xD;
      investigators can predict renal failure in patients receiving contrast enhanced CT's in the&#xD;
      emergency department. That would lead to an earlier nephrologist consult in those patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The use of contrast agents can - especially in already in impaired renal function - lead to a&#xD;
      decline in real function. The contrast enhanced CT is especially in emergency patients an&#xD;
      important diagnostic tool for example in the detection of pulmonary embolism or mesenteric&#xD;
      ischemia. Creatinine has been used as a marker for real function so far. But the&#xD;
      investigators all know that creatinine is not a perfect marker especially as it is influenced&#xD;
      by age, sex, weight and muscle mass. Especially in the diagnosis of acute renal failure&#xD;
      creatinine does not allow and recent change in the kidney function.&#xD;
&#xD;
      This prospective, unicentric study should therefore investigate two new markers in emergency&#xD;
      patients who need an emergency contrast enhanced CT to early predict pending kidney function&#xD;
      decline.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study failed to receive final approvement&#xD;
  </why_stopped>
  <start_date>May 2015</start_date>
  <completion_date type="Anticipated">June 2016</completion_date>
  <primary_completion_date type="Anticipated">May 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Renal function</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 7 days</time_frame>
    <description>renal function at discharge from hospital (creatinine and BUN measured at day of discharge)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Requirement for dialysis</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 7 days</time_frame>
    <description>dialysis required throughout hospital stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Admission to ICU</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 7 days</time_frame>
    <description>admission to ICU required throughout hospital stay</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Acute Kidney Injury</condition>
  <condition>Contrast Media</condition>
  <arm_group>
    <arm_group_label>normal creatinine</arm_group_label>
    <description>pts receiving an iv-contrast enhanced CT with normal baseline renal function</description>
  </arm_group>
  <arm_group>
    <arm_group_label>elevated creatinine</arm_group_label>
    <description>pts receiving an iv-contrast enhanced CT with abnormal baseline renal function</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum, urine&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients in the in emergency department who have the indication for contrast enhanced CT&#xD;
        and a predicted hospital admission time of 48 hours or longer.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients in the emergency department who have the indication for contrast enhanced CT&#xD;
             and a predicted hospital admission time of 48 hours or longer.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  children, pregnant women&#xD;
&#xD;
          -  dialysis&#xD;
&#xD;
          -  patients with kidney transplants&#xD;
&#xD;
          -  patients on steroids or further immunocompromised&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jan Braess, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Krankenhaus Barmherzige Brüder</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Krankenhaus Barmherzige Brueder</name>
      <address>
        <city>Regensburg</city>
        <state>Bavaria</state>
        <zip>93049</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Meersch M, Schmidt C, Van Aken H, Martens S, Rossaint J, Singbartl K, Gorlich D, Kellum JA, Zarbock A. Urinary TIMP-2 and IGFBP7 as early biomarkers of acute kidney injury and renal recovery following cardiac surgery. PLoS One. 2014 Mar 27;9(3):e93460. doi: 10.1371/journal.pone.0093460. eCollection 2014.</citation>
    <PMID>24675717</PMID>
  </reference>
  <reference>
    <citation>Olden M, Corre T, Hayward C, Toniolo D, Ulivi S, Gasparini P, Pistis G, Hwang SJ, Bergmann S, Campbell H, Cocca M, Gandin I, Girotto G, Glaudemans B, Hastie ND, Loffing J, Polasek O, Rampoldi L, Rudan I, Sala C, Traglia M, Vollenweider P, Vuckovic D, Youhanna S, Weber J, Wright AF, Kutalik Z, Bochud M, Fox CS, Devuyst O. Common variants in UMOD associate with urinary uromodulin levels: a meta-analysis. J Am Soc Nephrol. 2014 Aug;25(8):1869-82. doi: 10.1681/ASN.2013070781. Epub 2014 Feb 27.</citation>
    <PMID>24578125</PMID>
  </reference>
  <reference>
    <citation>Kellum JA, Lameire N; KDIGO AKI Guideline Work Group. Diagnosis, evaluation, and management of acute kidney injury: a KDIGO summary (Part 1). Crit Care. 2013 Feb 4;17(1):204. doi: 10.1186/cc11454.</citation>
    <PMID>23394211</PMID>
  </reference>
  <reference>
    <citation>Lameire N, Kellum JA; KDIGO AKI Guideline Work Group. Contrast-induced acute kidney injury and renal support for acute kidney injury: a KDIGO summary (Part 2). Crit Care. 2013 Feb 4;17(1):205. doi: 10.1186/cc11455.</citation>
    <PMID>23394215</PMID>
  </reference>
  <reference>
    <citation>Risch L, Lhotta K, Meier D, Medina-Escobar P, Nydegger UE, Risch M. The serum uromodulin level is associated with kidney function. Clin Chem Lab Med. 2014 Dec;52(12):1755-61. doi: 10.1515/cclm-2014-0505.</citation>
    <PMID>24933630</PMID>
  </reference>
  <reference>
    <citation>Bihorac A, Chawla LS, Shaw AD, Al-Khafaji A, Davison DL, Demuth GE, Fitzgerald R, Gong MN, Graham DD, Gunnerson K, Heung M, Jortani S, Kleerup E, Koyner JL, Krell K, Letourneau J, Lissauer M, Miner J, Nguyen HB, Ortega LM, Self WH, Sellman R, Shi J, Straseski J, Szalados JE, Wilber ST, Walker MG, Wilson J, Wunderink R, Zimmerman J, Kellum JA. Validation of cell-cycle arrest biomarkers for acute kidney injury using clinical adjudication. Am J Respir Crit Care Med. 2014 Apr 15;189(8):932-9. doi: 10.1164/rccm.201401-0077OC.</citation>
    <PMID>24559465</PMID>
  </reference>
  <reference>
    <citation>Kashani K, Al-Khafaji A, Ardiles T, Artigas A, Bagshaw SM, Bell M, Bihorac A, Birkhahn R, Cely CM, Chawla LS, Davison DL, Feldkamp T, Forni LG, Gong MN, Gunnerson KJ, Haase M, Hackett J, Honore PM, Hoste EA, Joannes-Boyau O, Joannidis M, Kim P, Koyner JL, Laskowitz DT, Lissauer ME, Marx G, McCullough PA, Mullaney S, Ostermann M, Rimmele T, Shapiro NI, Shaw AD, Shi J, Sprague AM, Vincent JL, Vinsonneau C, Wagner L, Walker MG, Wilkerson RG, Zacharowski K, Kellum JA. Discovery and validation of cell cycle arrest biomarkers in human acute kidney injury. Crit Care. 2013 Feb 6;17(1):R25. doi: 10.1186/cc12503.</citation>
    <PMID>23388612</PMID>
  </reference>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>October 3, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>August 18, 2022</last_update_submitted>
  <last_update_submitted_qc>August 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Emergency Medicine</keyword>
  <keyword>diagnosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Kidney Injury</mesh_term>
    <mesh_term>Emergencies</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/NCT02261909
org study id: 1
nct id: NCT02261909
lead sponsor: 
collaborator: 
has dmc: No
NephroCheck is measuring the concentration of a certain protein combination in the urine of
      patients. In elevated values there is a probability of renal failure (already proven in
      intensive care patients). The investigators would like to investigate whether the
      investigators can predict renal failure in patients receiving contrast enhanced CT's in the
      emergency department. That would lead to an earlier nephrologist consult in those patients.
The use of contrast agents can - especially in already in impaired renal function - lead to a
      decline in real function. The contrast enhanced CT is especially in emergency patients an
      important diagnostic tool for example in the detection of pulmonary embolism or mesenteric
      ischemia. Creatinine has been used as a marker for real function so far. But the
      investigators all know that creatinine is not a perfect marker especially as it is influenced
      by age, sex, weight and muscle mass. Especially in the diagnosis of acute renal failure
      creatinine does not allow and recent change in the kidney function.

      This prospective, unicentric study should therefore investigate two new markers in emergency
      patients who need an emergency contrast enhanced CT to early predict pending kidney function
      decline.
observational model: Case-Control
time perspective: Prospective
measure: Renal function
time frame: participants will be followed for the duration of hospital stay, an expected average of 7 days
description: renal function at discharge from hospital (creatinine and BUN measured at day of discharge)
measure: Requirement for dialysis
time frame: participants will be followed for the duration of hospital stay, an expected average of 7 days
description: dialysis required throughout hospital stay
measure: Admission to ICU
time frame: participants will be followed for the duration of hospital stay, an expected average of 7 days
description: admission to ICU required throughout hospital stay
arm group label: normal creatinine
description: pts receiving an iv-contrast enhanced CT with normal baseline renal function
arm group label: elevated creatinine
description: pts receiving an iv-contrast enhanced CT with abnormal baseline renal function
Serum, urine
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jan Braess, Prof
role: Study Chair
affiliation: Krankenhaus Barmherzige Brüder
facility: 
country: Germany
citation: Meersch M, Schmidt C, Van Aken H, Martens S, Rossaint J, Singbartl K, Gorlich D, Kellum JA, Zarbock A. Urinary TIMP-2 and IGFBP7 as early biomarkers of acute kidney injury and renal recovery following cardiac surgery. PLoS One. 2014 Mar 27;9(3):e93460. doi: 10.1371/journal.pone.0093460. eCollection 2014.
PMID: 24675717
citation: Olden M, Corre T, Hayward C, Toniolo D, Ulivi S, Gasparini P, Pistis G, Hwang SJ, Bergmann S, Campbell H, Cocca M, Gandin I, Girotto G, Glaudemans B, Hastie ND, Loffing J, Polasek O, Rampoldi L, Rudan I, Sala C, Traglia M, Vollenweider P, Vuckovic D, Youhanna S, Weber J, Wright AF, Kutalik Z, Bochud M, Fox CS, Devuyst O. Common variants in UMOD associate with urinary uromodulin levels: a meta-analysis. J Am Soc Nephrol. 2014 Aug;25(8):1869-82. doi: 10.1681/ASN.2013070781. Epub 2014 Feb 27.
PMID: 24578125
citation: Kellum JA, Lameire N; KDIGO AKI Guideline Work Group. Diagnosis, evaluation, and management of acute kidney injury: a KDIGO summary (Part 1). Crit Care. 2013 Feb 4;17(1):204. doi: 10.1186/cc11454.
PMID: 23394211
citation: Lameire N, Kellum JA; KDIGO AKI Guideline Work Group. Contrast-induced acute kidney injury and renal support for acute kidney injury: a KDIGO summary (Part 2). Crit Care. 2013 Feb 4;17(1):205. doi: 10.1186/cc11455.
PMID: 23394215
citation: Risch L, Lhotta K, Meier D, Medina-Escobar P, Nydegger UE, Risch M. The serum uromodulin level is associated with kidney function. Clin Chem Lab Med. 2014 Dec;52(12):1755-61. doi: 10.1515/cclm-2014-0505.
PMID: 24933630
citation: Bihorac A, Chawla LS, Shaw AD, Al-Khafaji A, Davison DL, Demuth GE, Fitzgerald R, Gong MN, Graham DD, Gunnerson K, Heung M, Jortani S, Kleerup E, Koyner JL, Krell K, Letourneau J, Lissauer M, Miner J, Nguyen HB, Ortega LM, Self WH, Sellman R, Shi J, Straseski J, Szalados JE, Wilber ST, Walker MG, Wilson J, Wunderink R, Zimmerman J, Kellum JA. Validation of cell-cycle arrest biomarkers for acute kidney injury using clinical adjudication. Am J Respir Crit Care Med. 2014 Apr 15;189(8):932-9. doi: 10.1164/rccm.201401-0077OC.
PMID: 24559465
citation: Kashani K, Al-Khafaji A, Ardiles T, Artigas A, Bagshaw SM, Bell M, Bihorac A, Birkhahn R, Cely CM, Chawla LS, Davison DL, Feldkamp T, Forni LG, Gong MN, Gunnerson KJ, Haase M, Hackett J, Honore PM, Hoste EA, Joannes-Boyau O, Joannidis M, Kim P, Koyner JL, Laskowitz DT, Lissauer ME, Marx G, McCullough PA, Mullaney S, Ostermann M, Rimmele T, Shapiro NI, Shaw AD, Shi J, Sprague AM, Vincent JL, Vinsonneau C, Wagner L, Walker MG, Wilkerson RG, Zacharowski K, Kellum JA. Discovery and validation of cell cycle arrest biomarkers in human acute kidney injury. Crit Care. 2013 Feb 6;17(1):R25. doi: 10.1186/cc12503.
PMID: 23388612
responsible party type: Sponsor
mesh term: Acute Kidney Injury
mesh term: Emergencies