Clinical trial NCT03795662: Surviving Pneumonia
Official title: Surviving Pneumonia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Community-acquired Pneumonia
Keywords: Community-acquired pneumonia
Diabetes
Immune status
Nutritional status
Physical inactivity
Risk factors
Lead sponsor: Nordsjaellands Hospital
Sponsor class: OTHER
First posted: 2019-01-08
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults (≥18 years) admitted with community-acquired pneumonia

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of death from any causes
timeFrame: From date of admission until the day of death from any causes, up to 24 months
measure: Number of participants who develop diabetes
timeFrame: Up to 24 months
Secondary outcomes:
measure: Length of hospital stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
measure: Oral glucose tolerance test
timeFrame: Day 1, discharge (an average of 5 days), 1 month and 6-month
measure: Number of participants who are readmitted
timeFrame: Up to 6 months
Other outcomes:
measure: Facal sample to assess changes in microbiome
timeFrame: Day 1, 1 month and 6 months
measure: Urine samples to assess metabolomics
timeFrame: Day 1, 1 month and 6 months
measure: Physical activity monitoring (measured by the AX3 accelerometers)
timeFrame: 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)
timeFrame: Day 1
measure: Muscle strength (measured by hand grip test)
timeFrame: Day 1, discharge (an average of 5 days), 1 months and 6 months
measure: Muscle strength (measured by 30-sec chair stand test)
timeFrame: Day 1 and discharge (an average of 5 days)
measure: Functional capacity (measured by 6-minutes walking test)
timeFrame: Day 1 and discharge (an average of 5 days)
measure: Activities of daily living (measured by Barthel100)
timeFrame: Discharge (an average of 5 days)
measure: BMI
timeFrame: Day 1, discharge (an average of 5 days), 1 month and 6 months
measure: Waist circumference (measured in cm)
timeFrame: Day 1, discharge (an average of 5 days), 1 month and 6 months
measure: Body composition analysis (measured by DEXA scans)
timeFrame: Day 1, discharge (an average of 5 days), 1 month and 6 months
measure: Body composition analysis (measured by bioimpedance)
timeFrame: Daily during admission, discharge (an average of 5 days), 1 month and 6 months
measure: Nutritional status (measured by NRS2002)
timeFrame: Day 1
measure: Concentration of p-phosphate (mmol/l), p-sodium (mmol/l), p-carbamide (mmol/l), p-potassium (mmol/l)
timeFrame: Daily during admission, 1 month and 6 months
measure: Concentration of pro- and anti-inflammatory cytokines (IL-6, Il-1ra, IL-18, IL-10, TNF-alpha)
timeFrame: 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
timeFrame: Day 1 and discharge (an average of 5 days)
measure: Concentration of blood lipids
timeFrame: Day 1, discharge (an average of 5 days), 1 month and 6 months
measure: Scoring of the Charlson Comorbidity Index to predict 10-year survival
timeFrame: Day 1
measure: Oral status (determined by revised oral assessment guide)
timeFrame: Day 1
measure: Dysphagia screening (eating assessment tool 10)
timeFrame: Day 1
measure: Quality of life (EQ-5D-5L)
timeFrame: Day 1, discharge (an average of 5 days), 1 month and 6 months
measure: Glycemic control during oral glucose tolerance test
timeFrame: Day 1, discharge (an average of 5 days), 1 month and 6 months
measure: Glucagon concentration during oral glucose tolerance test
timeFrame: Day 1, discharge (an average of 5 days), 1 month and 6 months
measure: Insulin concentration during oral glucose tolerance test
timeFrame: Day 1, discharge (an average of 5 days), 1 month and 6 months
measure: C-peptide concentration during oral glucose tolerance test
timeFrame: Day 1, discharge (an average of 5 days), 1 month and 6 months
measure: GLP-1 concentration during oral glucose tolerance test
timeFrame: Day 1, discharge (an average of 5 days), 1 month and 6 months
measure: GLP-2 concentration during oral glucose tolerance test
timeFrame: Day 1, discharge (an average of 5 days), 1 month and 6 months
measure: GIP concentration during oral glucose tolerance test
timeFrame: Day 1, discharge (an average of 5 days), 1 month and 6 months
measure: Insulin sensitivity index (Matsuda) based on oral glucose tolerance test
timeFrame: Day 1, discharge (an average of 5 days), 1 month and 6 months
measure: Insulin secretion index based on oral glucose tolerance test
timeFrame: 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)
timeFrame: Daily during admission, 1 month and 6 months
measure: Concentration of NT-proBNP (ng/l)
timeFrame: Daily during admission, 1 month and 6 months
measure: Z-value of left ventricle (LV) out of echocardiography
timeFrame: Discharge (an average of 5 days), 1 month and 6 months
measure: Z-value of right ventricle (RV) out of echocardiography
timeFrame: Discharge (an average of 5 days), 1 month and 6 months
measure: Z-value of left atrium (LA) out of echocardiography
timeFrame: Discharge (an average of 5 days), 1 month and 6 months
measure: Shortening fraction (SF) measured in echocardiography
timeFrame: Discharge (an average of 5 days), 1 month and 6 months
measure: Ejection fraction (EF) measured in echocardiography
timeFrame: Discharge (an average of 5 days), 1 month and 6 months
measure: Valvular insufficiency measured in echocardiography
timeFrame: Discharge (an average of 5 days), 1 month and 6 months
measure: Heart rate of 12-lead resting ECG
timeFrame: Daily during admission (up to 5 days)
measure: Rhythm during 12-lead resting ECG
timeFrame: Daily during admission (up to 5 days)
measure: Axis of the QRS complex out of the 12-lead resting ECG
timeFrame: Daily during admission (up to 5 days)
measure: Duration of PQ interval out of the 12-lead resting ECG
timeFrame: Daily during admission (up to 5 days)
measure: Duration of the QRS complex out of the 12-lead resting ECG
timeFrame: Daily during admission (up to 5 days)
measure: Number of cardiac events
timeFrame: From date of admission up to 24 months
measure: Sputum samples to assess glucose and lactate concentration (measured by ABL)
timeFrame: On admission, 1 month and 6 months
measure: Sputum samples to evaluate drug resistance and O2 content
timeFrame: On admission, 1 month and 6 months
measure: Forced vital capacity (FVC) during spirometry
timeFrame: Discharge (an average of 5 days)
measure: Forced expiratory volume in 1 second (FEV1) during spirometry
timeFrame: Discharge (an average of 5 days)
measure: FEV1% predicted during spirometry
timeFrame: Discharge (an average of 5 days)
measure: Chest x-ray to image inflammation of the lungs
timeFrame: On admission, 1 month and 6 months
measure: Early Warning Score (EWS) to identify patients at risk of deterioration in hospital
timeFrame: Daily during admission (up to 5 days)
measure: HbA1c to assess the average blood glucose levels 3 months before admission
timeFrame: Day 1
Locations:
city: Hillerød
country: Denmark
facility: Department of Pulmonary and Infectious Diseases, Nordsjællands Hospital
Study officials:
affiliation: Nordsjaellands Hospital
name: Birgitte Lindegaard, Assoc. Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ryrso CK, Hegelund MH, Dungu AM, Faurholt-Jepsen D, Pedersen BK, Ritz C, Krogh-Madsen R, Lindegaard B. Association between Barthel Index, Grip Strength, and Physical Activity Level at Admission and Prognosis in Community-Acquired Pneumonia: A Prospective Cohort Study. J Clin Med. 2022 Oct 27;11(21):6326. doi: 10.3390/jcm11216326.