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NCT Number: NCT03795662

Surviving Pneumonia

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.

Recruiting

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Key information

Conditions

Community-Acquired Pneumonia Behavior Community-Acquired Infections Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Infections Metabolic Diseases Nutritional and Metabolic Diseases Pneumonia Respiratory Tract Diseases Respiratory Tract Infections Sedentary Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Pulmonary and Infectious Diseases, Nordsjællands Hospital

Hillerød, 3400, Denmark

Location status: Recruiting

Location contact

Birgitte Lindegaard, MD, PhD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infiltrate on chest radiograph plus one or more of the following:
  • Fever (temperature, ≥38.0°C)
  • Hypothermia (<35.0°C),
  • New cough with or without sputum production
  • Pleuritic chest pain
  • Dyspnea
  • Altered breath sounds on auscultation.

Exclusion criteria

  • Patients unable to give informed consent
  • Patients unwilling to give informed consent

Treatment and study plan

No intervention

Other

Obervational

Primary outcomes

  1. Number of death from any causes

    Time frame: From date of admission until the day of death from any causes, up to 24 months

    Assessed through patient files

  2. Number of participants who develop diabetes

    Time frame: Up to 24 months

    Assessed through patient files and the national registers

Secondary outcomes

  1. Length of hospital stay

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days

    Through patient files

  2. Oral glucose tolerance test

    Time frame: Day 1, discharge (an average of 5 days), 1 month and 6-month

  3. Number of participants who are readmitted

    Time frame: Up to 6 months

    Through patient files

Other outcomes

  1. Facal sample to assess changes in microbiome

    Time frame: Day 1, 1 month and 6 months

  2. Urine samples to assess metabolomics

    Time frame: Day 1, 1 month and 6 months

  3. 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)

  4. Self-reported physical activity by scoring of the international physical activity questionnaire (IPAQ)

    Time frame: Day 1

  5. Muscle strength (measured by hand grip test)

    Time frame: Day 1, discharge (an average of 5 days), 1 months and 6 months

  6. Muscle strength (measured by 30-sec chair stand test)

    Time frame: Day 1 and discharge (an average of 5 days)

  7. Functional capacity (measured by 6-minutes walking test)

    Time frame: Day 1 and discharge (an average of 5 days)

  8. Activities of daily living (measured by Barthel100)

    Time frame: Discharge (an average of 5 days)

  9. BMI

    Time frame: Day 1, discharge (an average of 5 days), 1 month and 6 months

    Weight (kilograms) and height (cm) will be combined to report BMI in kg/m^2

  10. Waist circumference (measured in cm)

    Time frame: Day 1, discharge (an average of 5 days), 1 month and 6 months

  11. Body composition analysis (measured by DEXA scans)

    Time frame: Day 1, discharge (an average of 5 days), 1 month and 6 months

  12. Body composition analysis (measured by bioimpedance)

    Time frame: Daily during admission, discharge (an average of 5 days), 1 month and 6 months

  13. Nutritional status (measured by NRS2002)

    Time frame: Day 1

  14. 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

    Blood sampling

  15. 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

  16. 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)

    Flow cytometry on whole blood

  17. Concentration of blood lipids

    Time frame: Day 1, discharge (an average of 5 days), 1 month and 6 months

    Blood sampling

  18. Scoring of the Charlson Comorbidity Index to predict 10-year survival

    Time frame: Day 1

    Scale ranges from 0 to 33 points to predict survival (%)

  19. Oral status (determined by revised oral assessment guide)

    Time frame: Day 1

  20. Dysphagia screening (eating assessment tool 10)

    Time frame: Day 1

  21. Quality of life (EQ-5D-5L)

    Time frame: Day 1, discharge (an average of 5 days), 1 month and 6 months

  22. Glycemic control during oral glucose tolerance test

    Time frame: Day 1, discharge (an average of 5 days), 1 month and 6 months

  23. Glucagon concentration during oral glucose tolerance test

    Time frame: Day 1, discharge (an average of 5 days), 1 month and 6 months

    Blood sampling

  24. Insulin concentration during oral glucose tolerance test

    Time frame: Day 1, discharge (an average of 5 days), 1 month and 6 months

    Blood sampling

  25. C-peptide concentration during oral glucose tolerance test

    Time frame: Day 1, discharge (an average of 5 days), 1 month and 6 months

    Blood sampling

  26. GLP-1 concentration during oral glucose tolerance test

    Time frame: Day 1, discharge (an average of 5 days), 1 month and 6 months

    Blood sampling

  27. GLP-2 concentration during oral glucose tolerance test

    Time frame: Day 1, discharge (an average of 5 days), 1 month and 6 months

    Blood sampling

  28. GIP concentration during oral glucose tolerance test

    Time frame: Day 1, discharge (an average of 5 days), 1 month and 6 months

    Blood sampling

  29. 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

  30. Insulin secretion index based on oral glucose tolerance test

    Time frame: Day 1, discharge (an average of 5 days), 1 month and 6 months

  31. Concentration of galectin-3 (ng/ml), sST2 (ng/ml), and troponins (ng/ml)

    Time frame: Daily during admission, 1 month and 6 months

    Blood sampling

  32. Concentration of NT-proBNP (ng/l)

    Time frame: Daily during admission, 1 month and 6 months

    Blood sampling

  33. Z-value of left ventricle (LV) out of echocardiography

    Time frame: Discharge (an average of 5 days), 1 month and 6 months

    Z-value LV

  34. Z-value of right ventricle (RV) out of echocardiography

    Time frame: Discharge (an average of 5 days), 1 month and 6 months

    Z-value RV

  35. Z-value of left atrium (LA) out of echocardiography

    Time frame: Discharge (an average of 5 days), 1 month and 6 months

    Z-value LA

  36. Shortening fraction (SF) measured in echocardiography

    Time frame: Discharge (an average of 5 days), 1 month and 6 months

    SF (%)

  37. Ejection fraction (EF) measured in echocardiography

    Time frame: Discharge (an average of 5 days), 1 month and 6 months

    EF (%)

  38. Valvular insufficiency measured in echocardiography

    Time frame: Discharge (an average of 5 days), 1 month and 6 months

    Aorta valve regurgitation, pulmonary valve regurgitation, tricuspid valve regurgitation and mitral valve regurgitation (no, minimal, moderate, severe)

  39. Heart rate of 12-lead resting ECG

    Time frame: Daily during admission (up to 5 days)

    bpm

  40. Rhythm during 12-lead resting ECG

    Time frame: Daily during admission (up to 5 days)

    Sinus rhythm yes/no

  41. Axis of the QRS complex out of the 12-lead resting ECG

    Time frame: Daily during admission (up to 5 days)

    Degree

  42. Duration of PQ interval out of the 12-lead resting ECG

    Time frame: Daily during admission (up to 5 days)

    ms

  43. Duration of the QRS complex out of the 12-lead resting ECG

    Time frame: Daily during admission (up to 5 days)

    ms

  44. Number of cardiac events

    Time frame: From date of admission up to 24 months

    Assessed through patient files and the national registers

  45. Sputum samples to assess glucose and lactate concentration (measured by ABL)

    Time frame: On admission, 1 month and 6 months

  46. Sputum samples to evaluate drug resistance and O2 content

    Time frame: On admission, 1 month and 6 months

  47. Forced vital capacity (FVC) during spirometry

    Time frame: Discharge (an average of 5 days)

    Litre

  48. Forced expiratory volume in 1 second (FEV1) during spirometry

    Time frame: Discharge (an average of 5 days)

    Litre

  49. FEV1% predicted during spirometry

    Time frame: Discharge (an average of 5 days)

  50. Chest x-ray to image inflammation of the lungs

    Time frame: On admission, 1 month and 6 months

  51. Early Warning Score (EWS) to identify patients at risk of deterioration in hospital

    Time frame: Daily during admission (up to 5 days)

  52. HbA1c to assess the average blood glucose levels 3 months before admission

    Time frame: Day 1

Study contacts

Contact information is provided by the study sponsor or research team.

Camilla Ryrsø, MSc

CONTACT

[email protected]

+4548293250

Maria Hegelund, MSc

CONTACT

[email protected]

+4548293250

Sponsors and collaborators

Lead sponsor

Nordsjaellands Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2038
First posted
Jan 8, 2019
Registry last updated
Apr 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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