Trial document




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  DRKS00018692

Trial Description

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Title

Impact of indoor temperature on the vulnerable population of geratric patients in the context of climate change - An analysis of pulmonologic and geriatric outcomes

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

This observational trial will analyse the relation between critical events and heat. We will build a predictive temperature model for an outdoor-indoor-heat relation and associated risks.
Objective 1: Defining outdoor-indoor-relations for temperatures in patient rooms with and without air conditioning.

Objective 2: Analysis of critical events in association with heat. Analysis of incidence for COPD exacerbations, myocardial infarction, falls, stroke and others.

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Organizational Data

  •   DRKS00018692
  •   2019/10/09
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  •   yes
  •   Approved
  •   EA4/117/19, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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Health Condition or Problem studied

  •   COPD exacerbation, pneumonia, acute coronary syndrom, synkope, renal failure, electrolyte imbalances, stroke, fall, death.
  •   J44.1 -  Chronic obstructive pulmonary disease with acute exacerbation, unspecified
  •   J18.9 -  Pneumonia, unspecified
  •   I24.9 -  Acute ischaemic heart disease, unspecified
  •   R55 -  Syncope and collapse
  •   N19 -  Unspecified kidney failure
  •   E87.8 -  Other disorders of electrolyte and fluid balance, not elsewhere classified
  •   I64 -  Stroke, not specified as haemorrhage or infarction
  •   R99 -  Other ill-defined and unspecified causes of mortality
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Interventions/Observational Groups

  •   Outdoor- and indoor-temperatures are recorded in patient rooms and correlated to critical incidents (cf. health condition studied).
    In a first step patients are enrolled in the study and after hospital discharge, an analysis of hospital patient records is performed.
    In this study no additional diagnostic test or additional treatment is performed.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

COPD exacerbation, pneumonia, acute coronary syndrom, synkope, renal failure, electrolyte imbalances, stroke, fall, death. Patient transport to intermediate or intensive care unit, dropout of treatment/early discharge, extension of hospital stay.

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2019/10/01
  •   250
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   60   Years
  •   no maximum age
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Additional Inclusion Criteria

-Hospitalised, geriatric patient. (All patients of a geriatric ward/clinic are in line with the inclusion criteria). More specific inclusion criteria are not defined.

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Exclusion Criteria

-Patients not able to give consent, or patients of who the legal custodian refuses the inclusion of his client, patients that withdraw consent.

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Addresses

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    • Charité Campus Charité Mitte
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Charité Universitätsmedizin Berlin - Klinik für Geriatrie und Altersmedizin
    • Ms.  Prof. Dr.  Ursula  Müller-Werdan 
    • Hindenburgdamm 30
    • 12203  Berlin
    • Germany
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    • Charité Universitätsmedizin Berlin, CC12 Arbeitsbereich Ambulante Pneumologie, Campus Charité Mitte
    • Ms.  Dr.  Uta  Liebers 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Charité Universitätsmedizin Berlin, CC12 Arbeitsbereich Ambulante Pneumologie, Campus Charité Mitte
    • Ms.  Dr.  Uta  Liebers 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Charité Campus Charité Mitte
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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