<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/NCT03795662</url>
  </required_header>
  <id_info>
    <org_study_id>Surviving Pneumonia</org_study_id>
    <nct_id>NCT03795662</nct_id>
  </id_info>
  <brief_title>Surviving Pneumonia</brief_title>
  <official_title>Surviving Pneumonia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nordsjaellands Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nordsjaellands Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study aims to explore risk factors for poor prognosis among patients admitted with&#xD;
      community-acquired pneumonia (CAP). During a 5-year study period, all patients (aged ≥ 18&#xD;
      years) admitted with CAP at North Zealand Hospital will be invited for inclusion.&#xD;
      Questionnaires, anthropometric measures, laboratory tests, and biomaterials will be collected&#xD;
      at admission, daily during admission, at discharge and at follow-up. The main clinical&#xD;
      outcomes of the study consist of deaths and development of diabetes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 7, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2038</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>Number of death from any causes</measure>
    <time_frame>From date of admission until the day of death from any causes, up to 24 months</time_frame>
    <description>Assessed through patient files</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants who develop diabetes</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Assessed through patient files and the national registers</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 5 days</time_frame>
    <description>Through patient files</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oral glucose tolerance test</measure>
    <time_frame>Day 1, discharge (an average of 5 days), 1 month and 6-month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants who are readmitted</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Through patient files</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Facal sample to assess changes in microbiome</measure>
    <time_frame>Day 1, 1 month and 6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Urine samples to assess metabolomics</measure>
    <time_frame>Day 1, 1 month and 6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Physical activity monitoring (measured by the AX3 accelerometers)</measure>
    <time_frame>During admission (up to 7 days), 14 days from discharge (an average of 5 days)</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Self-reported physical activity by scoring of the international physical activity questionnaire (IPAQ)</measure>
    <time_frame>Day 1</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Muscle strength (measured by hand grip test)</measure>
    <time_frame>Day 1, discharge (an average of 5 days), 1 months and 6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Muscle strength (measured by 30-sec chair stand test)</measure>
    <time_frame>Day 1 and discharge (an average of 5 days)</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Functional capacity (measured by 6-minutes walking test)</measure>
    <time_frame>Day 1 and discharge (an average of 5 days)</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Activities of daily living (measured by Barthel100)</measure>
    <time_frame>Discharge (an average of 5 days)</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>BMI</measure>
    <time_frame>Day 1, discharge (an average of 5 days), 1 month and 6 months</time_frame>
    <description>Weight (kilograms) and height (cm) will be combined to report BMI in kg/m^2</description>
  </other_outcome>
  <other_outcome>
    <measure>Waist circumference (measured in cm)</measure>
    <time_frame>Day 1, discharge (an average of 5 days), 1 month and 6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Body composition analysis (measured by DEXA scans)</measure>
    <time_frame>Day 1, discharge (an average of 5 days), 1 month and 6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Body composition analysis (measured by bioimpedance)</measure>
    <time_frame>Daily during admission, discharge (an average of 5 days), 1 month and 6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Nutritional status (measured by NRS2002)</measure>
    <time_frame>Day 1</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Concentration of p-phosphate (mmol/l), p-sodium (mmol/l), p-carbamide (mmol/l), p-potassium (mmol/l)</measure>
    <time_frame>Daily during admission, 1 month and 6 months</time_frame>
    <description>Blood sampling</description>
  </other_outcome>
  <other_outcome>
    <measure>Concentration of pro- and anti-inflammatory cytokines (IL-6, Il-1ra, IL-18, IL-10, TNF-alpha)</measure>
    <time_frame>Daily during admission, discharge (an average of 5 days), 1 month and 6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Immune cell phenotyping to identify cell counts various T-cells, B-cells, NK-cells and monocytes</measure>
    <time_frame>Day 1 and discharge (an average of 5 days)</time_frame>
    <description>Flow cytometry on whole blood</description>
  </other_outcome>
  <other_outcome>
    <measure>Concentration of blood lipids</measure>
    <time_frame>Day 1, discharge (an average of 5 days), 1 month and 6 months</time_frame>
    <description>Blood sampling</description>
  </other_outcome>
  <other_outcome>
    <measure>Scoring of the Charlson Comorbidity Index to predict 10-year survival</measure>
    <time_frame>Day 1</time_frame>
    <description>Scale ranges from 0 to 33 points to predict survival (%)</description>
  </other_outcome>
  <other_outcome>
    <measure>Oral status (determined by revised oral assessment guide)</measure>
    <time_frame>Day 1</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Dysphagia screening (eating assessment tool 10)</measure>
    <time_frame>Day 1</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Quality of life (EQ-5D-5L)</measure>
    <time_frame>Day 1, discharge (an average of 5 days), 1 month and 6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Glycemic control during oral glucose tolerance test</measure>
    <time_frame>Day 1, discharge (an average of 5 days), 1 month and 6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Glucagon concentration during oral glucose tolerance test</measure>
    <time_frame>Day 1, discharge (an average of 5 days), 1 month and 6 months</time_frame>
    <description>Blood sampling</description>
  </other_outcome>
  <other_outcome>
    <measure>Insulin concentration during oral glucose tolerance test</measure>
    <time_frame>Day 1, discharge (an average of 5 days), 1 month and 6 months</time_frame>
    <description>Blood sampling</description>
  </other_outcome>
  <other_outcome>
    <measure>C-peptide concentration during oral glucose tolerance test</measure>
    <time_frame>Day 1, discharge (an average of 5 days), 1 month and 6 months</time_frame>
    <description>Blood sampling</description>
  </other_outcome>
  <other_outcome>
    <measure>GLP-1 concentration during oral glucose tolerance test</measure>
    <time_frame>Day 1, discharge (an average of 5 days), 1 month and 6 months</time_frame>
    <description>Blood sampling</description>
  </other_outcome>
  <other_outcome>
    <measure>GLP-2 concentration during oral glucose tolerance test</measure>
    <time_frame>Day 1, discharge (an average of 5 days), 1 month and 6 months</time_frame>
    <description>Blood sampling</description>
  </other_outcome>
  <other_outcome>
    <measure>GIP concentration during oral glucose tolerance test</measure>
    <time_frame>Day 1, discharge (an average of 5 days), 1 month and 6 months</time_frame>
    <description>Blood sampling</description>
  </other_outcome>
  <other_outcome>
    <measure>Insulin sensitivity index (Matsuda) based on oral glucose tolerance test</measure>
    <time_frame>Day 1, discharge (an average of 5 days), 1 month and 6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Insulin secretion index based on oral glucose tolerance test</measure>
    <time_frame>Day 1, discharge (an average of 5 days), 1 month and 6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Concentration of galectin-3 (ng/ml), sST2 (ng/ml), and troponins (ng/ml)</measure>
    <time_frame>Daily during admission, 1 month and 6 months</time_frame>
    <description>Blood sampling</description>
  </other_outcome>
  <other_outcome>
    <measure>Concentration of NT-proBNP (ng/l)</measure>
    <time_frame>Daily during admission, 1 month and 6 months</time_frame>
    <description>Blood sampling</description>
  </other_outcome>
  <other_outcome>
    <measure>Z-value of left ventricle (LV) out of echocardiography</measure>
    <time_frame>Discharge (an average of 5 days), 1 month and 6 months</time_frame>
    <description>Z-value LV</description>
  </other_outcome>
  <other_outcome>
    <measure>Z-value of right ventricle (RV) out of echocardiography</measure>
    <time_frame>Discharge (an average of 5 days), 1 month and 6 months</time_frame>
    <description>Z-value RV</description>
  </other_outcome>
  <other_outcome>
    <measure>Z-value of left atrium (LA) out of echocardiography</measure>
    <time_frame>Discharge (an average of 5 days), 1 month and 6 months</time_frame>
    <description>Z-value LA</description>
  </other_outcome>
  <other_outcome>
    <measure>Shortening fraction (SF) measured in echocardiography</measure>
    <time_frame>Discharge (an average of 5 days), 1 month and 6 months</time_frame>
    <description>SF (%)</description>
  </other_outcome>
  <other_outcome>
    <measure>Ejection fraction (EF) measured in echocardiography</measure>
    <time_frame>Discharge (an average of 5 days), 1 month and 6 months</time_frame>
    <description>EF (%)</description>
  </other_outcome>
  <other_outcome>
    <measure>Valvular insufficiency measured in echocardiography</measure>
    <time_frame>Discharge (an average of 5 days), 1 month and 6 months</time_frame>
    <description>Aorta valve regurgitation, pulmonary valve regurgitation, tricuspid valve regurgitation and mitral valve regurgitation (no, minimal, moderate, severe)</description>
  </other_outcome>
  <other_outcome>
    <measure>Heart rate of 12-lead resting ECG</measure>
    <time_frame>Daily during admission (up to 5 days)</time_frame>
    <description>bpm</description>
  </other_outcome>
  <other_outcome>
    <measure>Rhythm during 12-lead resting ECG</measure>
    <time_frame>Daily during admission (up to 5 days)</time_frame>
    <description>Sinus rhythm yes/no</description>
  </other_outcome>
  <other_outcome>
    <measure>Axis of the QRS complex out of the 12-lead resting ECG</measure>
    <time_frame>Daily during admission (up to 5 days)</time_frame>
    <description>Degree</description>
  </other_outcome>
  <other_outcome>
    <measure>Duration of PQ interval out of the 12-lead resting ECG</measure>
    <time_frame>Daily during admission (up to 5 days)</time_frame>
    <description>ms</description>
  </other_outcome>
  <other_outcome>
    <measure>Duration of the QRS complex out of the 12-lead resting ECG</measure>
    <time_frame>Daily during admission (up to 5 days)</time_frame>
    <description>ms</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of cardiac events</measure>
    <time_frame>From date of admission up to 24 months</time_frame>
    <description>Assessed through patient files and the national registers</description>
  </other_outcome>
  <other_outcome>
    <measure>Sputum samples to assess glucose and lactate concentration (measured by ABL)</measure>
    <time_frame>On admission, 1 month and 6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Sputum samples to evaluate drug resistance and O2 content</measure>
    <time_frame>On admission, 1 month and 6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Forced vital capacity (FVC) during spirometry</measure>
    <time_frame>Discharge (an average of 5 days)</time_frame>
    <description>Litre</description>
  </other_outcome>
  <other_outcome>
    <measure>Forced expiratory volume in 1 second (FEV1) during spirometry</measure>
    <time_frame>Discharge (an average of 5 days)</time_frame>
    <description>Litre</description>
  </other_outcome>
  <other_outcome>
    <measure>FEV1% predicted during spirometry</measure>
    <time_frame>Discharge (an average of 5 days)</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Chest x-ray to image inflammation of the lungs</measure>
    <time_frame>On admission, 1 month and 6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Early Warning Score (EWS) to identify patients at risk of deterioration in hospital</measure>
    <time_frame>Daily during admission (up to 5 days)</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>HbA1c to assess the average blood glucose levels 3 months before admission</measure>
    <time_frame>Day 1</time_frame>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">2500</enrollment>
  <condition>Community-acquired Pneumonia</condition>
  <arm_group>
    <arm_group_label>Community-acquired pneumonia</arm_group_label>
    <description>Adults over 18 years old admitted with confirmed community-acquired pneumonia.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>Obervational</description>
    <arm_group_label>Community-acquired pneumonia</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole blood samples Urine samples Fecal samples Airway samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Adults (≥18 years) admitted with community-acquired pneumonia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infiltrate on chest radiograph plus one or more of the following:&#xD;
&#xD;
               -  Fever (temperature, ≥38.0°C)&#xD;
&#xD;
               -  Hypothermia (&lt;35.0°C),&#xD;
&#xD;
               -  New cough with or without sputum production&#xD;
&#xD;
               -  Pleuritic chest pain&#xD;
&#xD;
               -  Dyspnea&#xD;
&#xD;
               -  Altered breath sounds on auscultation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients unable to give informed consent&#xD;
&#xD;
          -  Patients unwilling to give informed consent&#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>Birgitte Lindegaard, Assoc. Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nordsjaellands Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Camilla Ryrsø, MSc</last_name>
    <phone>+4548293250</phone>
    <email>camilla.koch.ryrsoe.01@regionh.dk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Maria Hegelund, MSc</last_name>
    <phone>+4548293250</phone>
    <email>maria.hein.hegelund.01@regionh.dk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Pulmonary and Infectious Diseases, Nordsjællands Hospital</name>
      <address>
        <city>Hillerød</city>
        <zip>3400</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Birgitte Lindegaard, MD, PhD</last_name>
      <email>birgitte.lindegaard.madsen@regionh.dk</email>
    </contact>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>November 9, 2018</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>April 28, 2021</last_update_submitted>
  <last_update_submitted_qc>April 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nordsjaellands Hospital</investigator_affiliation>
    <investigator_full_name>Birgitte Lindegaard Madsen</investigator_full_name>
    <investigator_title>Associated professor, MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Community-acquired pneumonia</keyword>
  <keyword>Diabetes</keyword>
  <keyword>Immune status</keyword>
  <keyword>Nutritional status</keyword>
  <keyword>Physical inactivity</keyword>
  <keyword>Risk factors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03795662
org study id: Surviving Pneumonia
nct id: NCT03795662
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The study aims to explore risk factors for poor prognosis among patients admitted with
      community-acquired pneumonia (CAP). During a 5-year study period, all patients (aged ≥ 18
      years) admitted with CAP at North Zealand Hospital will be invited for inclusion.
      Questionnaires, anthropometric measures, laboratory tests, and biomaterials will be collected
      at admission, daily during admission, at discharge and at follow-up. The main clinical
      outcomes of the study consist of deaths and development of diabetes.
observational model: Cohort
time perspective: Prospective
measure: Number of death from any causes
time frame: From date of admission until the day of death from any causes, up to 24 months
description: Assessed through patient files
measure: Number of participants who develop diabetes
time frame: Up to 24 months
description: Assessed through patient files and the national registers
measure: Length of hospital stay
time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
description: Through patient files
measure: Oral glucose tolerance test
time frame: Day 1, discharge (an average of 5 days), 1 month and 6-month
measure: Number of participants who are readmitted
time frame: Up to 6 months
description: Through patient files
measure: Facal sample to assess changes in microbiome
time frame: Day 1, 1 month and 6 months
measure: Urine samples to assess metabolomics
time frame: Day 1, 1 month and 6 months
measure: Physical activity monitoring (measured by the AX3 accelerometers)
time frame: During admission (up to 7 days), 14 days from discharge (an average of 5 days)
measure: Self-reported physical activity by scoring of the international physical activity questionnaire (IPAQ)
time frame: Day 1
measure: Muscle strength (measured by hand grip test)
time frame: Day 1, discharge (an average of 5 days), 1 months and 6 months
measure: Muscle strength (measured by 30-sec chair stand test)
time frame: Day 1 and discharge (an average of 5 days)
measure: Functional capacity (measured by 6-minutes walking test)
time frame: Day 1 and discharge (an average of 5 days)
measure: Activities of daily living (measured by Barthel100)
time frame: Discharge (an average of 5 days)
measure: BMI
time frame: Day 1, discharge (an average of 5 days), 1 month and 6 months
description: Weight (kilograms) and height (cm) will be combined to report BMI in kg/m^2
measure: Waist circumference (measured in cm)
time frame: Day 1, discharge (an average of 5 days), 1 month and 6 months
measure: Body composition analysis (measured by DEXA scans)
time frame: Day 1, discharge (an average of 5 days), 1 month and 6 months
measure: Body composition analysis (measured by bioimpedance)
time frame: Daily during admission, discharge (an average of 5 days), 1 month and 6 months
measure: Nutritional status (measured by NRS2002)
time frame: Day 1
measure: Concentration of p-phosphate (mmol/l), p-sodium (mmol/l), p-carbamide (mmol/l), p-potassium (mmol/l)
time frame: Daily during admission, 1 month and 6 months
description: Blood sampling
measure: Concentration of pro- and anti-inflammatory cytokines (IL-6, Il-1ra, IL-18, IL-10, TNF-alpha)
time frame: Daily during admission, discharge (an average of 5 days), 1 month and 6 months
measure: Immune cell phenotyping to identify cell counts various T-cells, B-cells, NK-cells and monocytes
time frame: Day 1 and discharge (an average of 5 days)
description: Flow cytometry on whole blood
measure: Concentration of blood lipids
time frame: Day 1, discharge (an average of 5 days), 1 month and 6 months
description: Blood sampling
measure: Scoring of the Charlson Comorbidity Index to predict 10-year survival
time frame: Day 1
description: Scale ranges from 0 to 33 points to predict survival (%)
measure: Oral status (determined by revised oral assessment guide)
time frame: Day 1
measure: Dysphagia screening (eating assessment tool 10)
time frame: Day 1
measure: Quality of life (EQ-5D-5L)
time frame: Day 1, discharge (an average of 5 days), 1 month and 6 months
measure: Glycemic control during oral glucose tolerance test
time frame: Day 1, discharge (an average of 5 days), 1 month and 6 months
measure: Glucagon concentration during oral glucose tolerance test
time frame: Day 1, discharge (an average of 5 days), 1 month and 6 months
description: Blood sampling
measure: Insulin concentration during oral glucose tolerance test
time frame: Day 1, discharge (an average of 5 days), 1 month and 6 months
description: Blood sampling
measure: C-peptide concentration during oral glucose tolerance test
time frame: Day 1, discharge (an average of 5 days), 1 month and 6 months
description: Blood sampling
measure: GLP-1 concentration during oral glucose tolerance test
time frame: Day 1, discharge (an average of 5 days), 1 month and 6 months
description: Blood sampling
measure: GLP-2 concentration during oral glucose tolerance test
time frame: Day 1, discharge (an average of 5 days), 1 month and 6 months
description: Blood sampling
measure: GIP concentration during oral glucose tolerance test
time frame: Day 1, discharge (an average of 5 days), 1 month and 6 months
description: Blood sampling
measure: Insulin sensitivity index (Matsuda) based on oral glucose tolerance test
time frame: Day 1, discharge (an average of 5 days), 1 month and 6 months
measure: Insulin secretion index based on oral glucose tolerance test
time frame: Day 1, discharge (an average of 5 days), 1 month and 6 months
measure: Concentration of galectin-3 (ng/ml), sST2 (ng/ml), and troponins (ng/ml)
time frame: Daily during admission, 1 month and 6 months
description: Blood sampling
measure: Concentration of NT-proBNP (ng/l)
time frame: Daily during admission, 1 month and 6 months
description: Blood sampling
measure: Z-value of left ventricle (LV) out of echocardiography
time frame: Discharge (an average of 5 days), 1 month and 6 months
description: Z-value LV
measure: Z-value of right ventricle (RV) out of echocardiography
time frame: Discharge (an average of 5 days), 1 month and 6 months
description: Z-value RV
measure: Z-value of left atrium (LA) out of echocardiography
time frame: Discharge (an average of 5 days), 1 month and 6 months
description: Z-value LA
measure: Shortening fraction (SF) measured in echocardiography
time frame: Discharge (an average of 5 days), 1 month and 6 months
description: SF (%)
measure: Ejection fraction (EF) measured in echocardiography
time frame: Discharge (an average of 5 days), 1 month and 6 months
description: EF (%)
measure: Valvular insufficiency measured in echocardiography
time frame: Discharge (an average of 5 days), 1 month and 6 months
description: Aorta valve regurgitation, pulmonary valve regurgitation, tricuspid valve regurgitation and mitral valve regurgitation (no, minimal, moderate, severe)
measure: Heart rate of 12-lead resting ECG
time frame: Daily during admission (up to 5 days)
description: bpm
measure: Rhythm during 12-lead resting ECG
time frame: Daily during admission (up to 5 days)
description: Sinus rhythm yes/no
measure: Axis of the QRS complex out of the 12-lead resting ECG
time frame: Daily during admission (up to 5 days)
description: Degree
measure: Duration of PQ interval out of the 12-lead resting ECG
time frame: Daily during admission (up to 5 days)
description: ms
measure: Duration of the QRS complex out of the 12-lead resting ECG
time frame: Daily during admission (up to 5 days)
description: ms
measure: Number of cardiac events
time frame: From date of admission up to 24 months
description: Assessed through patient files and the national registers
measure: Sputum samples to assess glucose and lactate concentration (measured by ABL)
time frame: On admission, 1 month and 6 months
measure: Sputum samples to evaluate drug resistance and O2 content
time frame: On admission, 1 month and 6 months
measure: Forced vital capacity (FVC) during spirometry
time frame: Discharge (an average of 5 days)
description: Litre
measure: Forced expiratory volume in 1 second (FEV1) during spirometry
time frame: Discharge (an average of 5 days)
description: Litre
measure: FEV1% predicted during spirometry
time frame: Discharge (an average of 5 days)
measure: Chest x-ray to image inflammation of the lungs
time frame: On admission, 1 month and 6 months
measure: Early Warning Score (EWS) to identify patients at risk of deterioration in hospital
time frame: Daily during admission (up to 5 days)
measure: HbA1c to assess the average blood glucose levels 3 months before admission
time frame: Day 1
arm group label: Community-acquired pneumonia
description: Adults over 18 years old admitted with confirmed community-acquired pneumonia.
intervention type: Other
intervention name: No intervention
description: Obervational
arm group label: Community-acquired pneumonia
Whole blood samples Urine samples Fecal samples Airway samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Birgitte Lindegaard, Assoc. Prof
role: Principal Investigator
affiliation: Nordsjaellands Hospital
last name: Camilla Ryrsø, MSc
phone: +4548293250
email: camilla.koch.ryrsoe.01@regionh.dk
last name: Maria Hegelund, MSc
phone: +4548293250
email: maria.hein.hegelund.01@regionh.dk
facility: 
status: Recruiting
contact: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Nordsjaellands Hospital
investigator full name: Birgitte Lindegaard Madsen
investigator title: Associated professor, MD, PhD
mesh term: Pneumonia
sharing ipd: No