<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/NCT03789305</url>
  </required_header>
  <id_info>
    <org_study_id>DEFAULT</org_study_id>
    <nct_id>NCT03789305</nct_id>
  </id_info>
  <brief_title>Differences in Frail and Non-frail Critically-ill Patients in Functional Outcomes</brief_title>
  <acronym>DEFAULT</acronym>
  <official_title>Differences in Frail and Non-frail Critically-ill Patients in Functional Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Technical University of Munich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Technical University of Munich</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>
      This is a prospective analysis of patient registry data of intensive care patients. The aim&#xD;
      is to investigate if frailty is a predictor of decline of functional status of critically ill&#xD;
      patients during their hospital stay.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Elderly critical-ill patients with a high frailty level are becoming increasingly important&#xD;
      in the ICU and the health system. Especially, questions about the course of the individual&#xD;
      proceeding, withhold of therapy and level of care are controversial among caretakers, as&#xD;
      outcome and functional independence remain still unclear in these patients.&#xD;
&#xD;
      This applies particularly in view of the fact that large studies such as VIP1 showed an&#xD;
      inverse association of high frailty classes with short-term survival.&#xD;
&#xD;
      Our main objective in this study was to focus on functional outcome and independency measured&#xD;
      by Barthel Index after ICU stay regarding frailty, the effect of critical care and severity&#xD;
      and prognosis of the disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Actual">May 31, 2018</completion_date>
  <primary_completion_date type="Actual">May 31, 2018</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>Probability not to deteriorate in functional status during the hospital stay</measure>
    <time_frame>a median of 30 days</time_frame>
    <description>Analysis of the course of functional status measured by the Barthel Score sub-components transfer and ambulation during the hospital stay. The Scale ranges from 0 (no transfer) to 15 (transfer to chair and back) for transfer and from 0 (no ambulation) to 15 (coming into stand and walk 50m without supervision) for ambulation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Functional status before hospital admission to ICU discharge</measure>
    <time_frame>a median of 20 days</time_frame>
    <description>Analysis of the change of functional status measured by the Barthel Score sub-components transfer and ambulation from before hospital admission to ICU discharge. The Scale ranges from 0 (no transfer) to 15 (transfer to chair and back) for transfer and from 0 (no ambulation) to 15 (coming into stand and walk 50m without supervision) for ambulation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Functional status before hospital admission to hospital discharge</measure>
    <time_frame>a median of 30 days</time_frame>
    <description>Analysis of the change of functional status measured by the Barthel Score sub-components transfer and ambulation from before hospital admission to hospital discharge. The Scale ranges from 0 (no transfer) to 15 (transfer to chair and back) for transfer and from 0 (no ambulation) to 15 (coming into stand and walk 50m without supervision) for ambulation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU length of stay</measure>
    <time_frame>a median of 11 days</time_frame>
    <description>Duration of stay on intensive care</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>a median of 30 days</time_frame>
    <description>Duration of stay in the hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of discharge disposition to home</measure>
    <time_frame>1 day</time_frame>
    <description>Rate of participants being discharged home after the hospital stay.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU mortality</measure>
    <time_frame>a median of 11 days</time_frame>
    <description>Expired during the intensive care stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital mortality</measure>
    <time_frame>a median of 22 days</time_frame>
    <description>Expired during the hospital stay</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">731</enrollment>
  <condition>Critical Care</condition>
  <condition>Rehabilitation</condition>
  <condition>Outcome Assessment</condition>
  <condition>Critical Illness</condition>
  <condition>Frailty</condition>
  <condition>Physical and Rehabilitation Medicine</condition>
  <condition>Exercise Therapy</condition>
  <condition>Intensive Care Unit</condition>
  <arm_group>
    <arm_group_label>Critically ill patients</arm_group_label>
    <description>Critically ill patients admitted to intensive care for more than 48 hours</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Critically ill patients admitted to two intensive care units at a university hospital from&#xD;
        the Department of Anesthesiology and Intensive Care in Munich, Germany.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  intensive care stay &gt; 48 hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#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>Stefan J Schaller, MD, MHBA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Technical University of Munich</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Klinikum rechts der Isar, School of Medicine, Technical University of Munich</name>
      <address>
        <city>Munich</city>
        <state>Bavaria</state>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8. Erratum In: Lancet. 2013 Oct 19;382(9901):1328.</citation>
    <PMID>23395245</PMID>
  </reference>
  <reference>
    <citation>Flaatten H, De Lange DW, Morandi A, Andersen FH, Artigas A, Bertolini G, Boumendil A, Cecconi M, Christensen S, Faraldi L, Fjolner J, Jung C, Marsh B, Moreno R, Oeyen S, Ohman CA, Pinto BB, Soliman IW, Szczeklik W, Valentin A, Watson X, Zaferidis T, Guidet B; VIP1 study group. The impact of frailty on ICU and 30-day mortality and the level of care in very elderly patients (&gt;/= 80 years). Intensive Care Med. 2017 Dec;43(12):1820-1828. doi: 10.1007/s00134-017-4940-8. Epub 2017 Sep 21.</citation>
    <PMID>28936626</PMID>
  </reference>
  <reference>
    <citation>Latronico N, Herridge M, Hopkins RO, Angus D, Hart N, Hermans G, Iwashyna T, Arabi Y, Citerio G, Ely EW, Hall J, Mehta S, Puntillo K, Van den Hoeven J, Wunsch H, Cook D, Dos Santos C, Rubenfeld G, Vincent JL, Van den Berghe G, Azoulay E, Needham DM. The ICM research agenda on intensive care unit-acquired weakness. Intensive Care Med. 2017 Sep;43(9):1270-1281. doi: 10.1007/s00134-017-4757-5. Epub 2017 Mar 13.</citation>
    <PMID>28289812</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 25, 2018</study_first_submitted>
  <study_first_submitted_qc>December 25, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <last_update_submitted>January 19, 2019</last_update_submitted>
  <last_update_submitted_qc>January 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Technical University of Munich</investigator_affiliation>
    <investigator_full_name>Stefan Schaller</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Early Mobilization</keyword>
  <keyword>Early Rehabilitation</keyword>
  <keyword>Functional Status</keyword>
  <keyword>Functional Outcome</keyword>
  <keyword>Patient Outcome</keyword>
  <keyword>Intensive Care</keyword>
  <keyword>Critical Care Outcomes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</mesh_term>
    <mesh_term>Frailty</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Anonymized data will be made available to other researchers on reasonable request. A data share agreement will have to be signed by both parties.&#xD;
Examples of reasonable requests are:&#xD;
a metaanalysis in the field&#xD;
a research collaboration&#xD;
rerun the analysis Data will only be provided for the purpose requested and may not be used otherwise without authorization/agreement.</ipd_description>
  </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/NCT03789305
org study id: DEFAULT
nct id: NCT03789305
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a prospective analysis of patient registry data of intensive care patients. The aim
      is to investigate if frailty is a predictor of decline of functional status of critically ill
      patients during their hospital stay.
Elderly critical-ill patients with a high frailty level are becoming increasingly important
      in the ICU and the health system. Especially, questions about the course of the individual
      proceeding, withhold of therapy and level of care are controversial among caretakers, as
      outcome and functional independence remain still unclear in these patients.

      This applies particularly in view of the fact that large studies such as VIP1 showed an
      inverse association of high frailty classes with short-term survival.

      Our main objective in this study was to focus on functional outcome and independency measured
      by Barthel Index after ICU stay regarding frailty, the effect of critical care and severity
      and prognosis of the disease.
observational model: Cohort
time perspective: Prospective
measure: Probability not to deteriorate in functional status during the hospital stay
time frame: a median of 30 days
description: Analysis of the course of functional status measured by the Barthel Score sub-components transfer and ambulation during the hospital stay. The Scale ranges from 0 (no transfer) to 15 (transfer to chair and back) for transfer and from 0 (no ambulation) to 15 (coming into stand and walk 50m without supervision) for ambulation.
measure: Change in Functional status before hospital admission to ICU discharge
time frame: a median of 20 days
description: Analysis of the change of functional status measured by the Barthel Score sub-components transfer and ambulation from before hospital admission to ICU discharge. The Scale ranges from 0 (no transfer) to 15 (transfer to chair and back) for transfer and from 0 (no ambulation) to 15 (coming into stand and walk 50m without supervision) for ambulation.
measure: Change in Functional status before hospital admission to hospital discharge
time frame: a median of 30 days
description: Analysis of the change of functional status measured by the Barthel Score sub-components transfer and ambulation from before hospital admission to hospital discharge. The Scale ranges from 0 (no transfer) to 15 (transfer to chair and back) for transfer and from 0 (no ambulation) to 15 (coming into stand and walk 50m without supervision) for ambulation.
measure: ICU length of stay
time frame: a median of 11 days
description: Duration of stay on intensive care
measure: Hospital length of stay
time frame: a median of 30 days
description: Duration of stay in the hospital
measure: Rate of discharge disposition to home
time frame: 1 day
description: Rate of participants being discharged home after the hospital stay.
measure: ICU mortality
time frame: a median of 11 days
description: Expired during the intensive care stay
measure: Hospital mortality
time frame: a median of 22 days
description: Expired during the hospital stay
arm group label: Critically ill patients
description: Critically ill patients admitted to intensive care for more than 48 hours
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stefan J Schaller, MD, MHBA
role: Principal Investigator
affiliation: Technical University of Munich
facility: 
country: Germany
citation: Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8. Erratum In: Lancet. 2013 Oct 19;382(9901):1328.
PMID: 23395245
citation: Flaatten H, De Lange DW, Morandi A, Andersen FH, Artigas A, Bertolini G, Boumendil A, Cecconi M, Christensen S, Faraldi L, Fjolner J, Jung C, Marsh B, Moreno R, Oeyen S, Ohman CA, Pinto BB, Soliman IW, Szczeklik W, Valentin A, Watson X, Zaferidis T, Guidet B; VIP1 study group. The impact of frailty on ICU and 30-day mortality and the level of care in very elderly patients (>/= 80 years). Intensive Care Med. 2017 Dec;43(12):1820-1828. doi: 10.1007/s00134-017-4940-8. Epub 2017 Sep 21.
PMID: 28936626
citation: Latronico N, Herridge M, Hopkins RO, Angus D, Hart N, Hermans G, Iwashyna T, Arabi Y, Citerio G, Ely EW, Hall J, Mehta S, Puntillo K, Van den Hoeven J, Wunsch H, Cook D, Dos Santos C, Rubenfeld G, Vincent JL, Van den Berghe G, Azoulay E, Needham DM. The ICM research agenda on intensive care unit-acquired weakness. Intensive Care Med. 2017 Sep;43(9):1270-1281. doi: 10.1007/s00134-017-4757-5. Epub 2017 Mar 13.
PMID: 28289812
responsible party type: Principal Investigator
investigator affiliation: Technical University of Munich
investigator full name: Stefan Schaller
investigator title: Principal Investigator
mesh term: Critical Illness
mesh term: Frailty
sharing ipd: Undecided
ipd description: Anonymized data will be made available to other researchers on reasonable request. A data share agreement will have to be signed by both parties.
Examples of reasonable requests are:
a metaanalysis in the field
a research collaboration
rerun the analysis Data will only be provided for the purpose requested and may not be used otherwise without authorization/agreement.