Community-acquired Pneumonia
Conditions
Keywords
Community-acquired pneumonia, Diabetes, Immune status, Nutritional status, Physical inactivity, Risk factors
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.
Interventions
Obervational
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of death from any causes | From date of admission until the day of death from any causes, up to 24 months | Assessed through patient files |
| Number of participants who develop diabetes | Up to 24 months | Assessed through patient files and the national registers |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | Participants will be followed for the duration of hospital stay, an expected average of 5 days | Through patient files |
| Oral glucose tolerance test | Day 1, discharge (an average of 5 days), 1 month and 6-month | — |
| Number of participants who are readmitted | Up to 6 months | Through patient files |
Other
| Measure | Time frame | Description |
|---|---|---|
| Physical activity monitoring (measured by the AX3 accelerometers) | During admission (up to 7 days), 14 days from discharge (an average of 5 days) | — |
| Self-reported physical activity by scoring of the international physical activity questionnaire (IPAQ) | Day 1 | — |
| Muscle strength (measured by hand grip test) | Day 1, discharge (an average of 5 days), 1 months and 6 months | — |
| Muscle strength (measured by 30-sec chair stand test) | Day 1 and discharge (an average of 5 days) | — |
| Functional capacity (measured by 6-minutes walking test) | Day 1 and discharge (an average of 5 days) | — |
| Activities of daily living (measured by Barthel100) | Discharge (an average of 5 days) | — |
| BMI | 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 |
| Waist circumference (measured in cm) | Day 1, discharge (an average of 5 days), 1 month and 6 months | — |
| Body composition analysis (measured by DEXA scans) | Day 1, discharge (an average of 5 days), 1 month and 6 months | — |
| Body composition analysis (measured by bioimpedance) | Daily during admission, discharge (an average of 5 days), 1 month and 6 months | — |
| Nutritional status (measured by NRS2002) | Day 1 | — |
| Concentration of p-phosphate (mmol/l), p-sodium (mmol/l), p-carbamide (mmol/l), p-potassium (mmol/l) | Daily during admission, 1 month and 6 months | Blood sampling |
| Concentration of pro- and anti-inflammatory cytokines (IL-6, Il-1ra, IL-18, IL-10, TNF-alpha) | Daily during admission, discharge (an average of 5 days), 1 month and 6 months | — |
| Immune cell phenotyping to identify cell counts various T-cells, B-cells, NK-cells and monocytes | Day 1 and discharge (an average of 5 days) | Flow cytometry on whole blood |
| Concentration of blood lipids | Day 1, discharge (an average of 5 days), 1 month and 6 months | Blood sampling |
| Scoring of the Charlson Comorbidity Index to predict 10-year survival | Day 1 | Scale ranges from 0 to 33 points to predict survival (%) |
| Oral status (determined by revised oral assessment guide) | Day 1 | — |
| Dysphagia screening (eating assessment tool 10) | Day 1 | — |
| Quality of life (EQ-5D-5L) | Day 1, discharge (an average of 5 days), 1 month and 6 months | — |
| Glycemic control during oral glucose tolerance test | Day 1, discharge (an average of 5 days), 1 month and 6 months | — |
| Glucagon concentration during oral glucose tolerance test | Day 1, discharge (an average of 5 days), 1 month and 6 months | Blood sampling |
| Insulin concentration during oral glucose tolerance test | Day 1, discharge (an average of 5 days), 1 month and 6 months | Blood sampling |
| C-peptide concentration during oral glucose tolerance test | Day 1, discharge (an average of 5 days), 1 month and 6 months | Blood sampling |
| GLP-1 concentration during oral glucose tolerance test | Day 1, discharge (an average of 5 days), 1 month and 6 months | Blood sampling |
| GLP-2 concentration during oral glucose tolerance test | Day 1, discharge (an average of 5 days), 1 month and 6 months | Blood sampling |
| GIP concentration during oral glucose tolerance test | Day 1, discharge (an average of 5 days), 1 month and 6 months | Blood sampling |
| Insulin sensitivity index (Matsuda) based on oral glucose tolerance test | Day 1, discharge (an average of 5 days), 1 month and 6 months | — |
| Insulin secretion index based on oral glucose tolerance test | Day 1, discharge (an average of 5 days), 1 month and 6 months | — |
| Concentration of galectin-3 (ng/ml), sST2 (ng/ml), and troponins (ng/ml) | Daily during admission, 1 month and 6 months | Blood sampling |
| Concentration of NT-proBNP (ng/l) | Daily during admission, 1 month and 6 months | Blood sampling |
| Chest x-ray to image inflammation of the lungs | On admission, 1 month and 6 months | — |
| Z-value of left ventricle (LV) out of echocardiography | Discharge (an average of 5 days), 1 month and 6 months | Z-value LV |
| Z-value of right ventricle (RV) out of echocardiography | Discharge (an average of 5 days), 1 month and 6 months | Z-value RV |
| Z-value of left atrium (LA) out of echocardiography | Discharge (an average of 5 days), 1 month and 6 months | Z-value LA |
| Shortening fraction (SF) measured in echocardiography | Discharge (an average of 5 days), 1 month and 6 months | SF (%) |
| Ejection fraction (EF) measured in echocardiography | Discharge (an average of 5 days), 1 month and 6 months | EF (%) |
| Valvular insufficiency measured in echocardiography | 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) |
| Heart rate of 12-lead resting ECG | Daily during admission (up to 5 days) | bpm |
| Rhythm during 12-lead resting ECG | Daily during admission (up to 5 days) | Sinus rhythm yes/no |
| Axis of the QRS complex out of the 12-lead resting ECG | Daily during admission (up to 5 days) | Degree |
| Number of cardiac events | From date of admission up to 24 months | Assessed through patient files and the national registers |
| Sputum samples to assess glucose and lactate concentration (measured by ABL) | On admission, 1 month and 6 months | — |
| Sputum samples to evaluate drug resistance and O2 content | On admission, 1 month and 6 months | — |
| Forced vital capacity (FVC) during spirometry | Discharge (an average of 5 days) | Litre |
| Duration of PQ interval out of the 12-lead resting ECG | Daily during admission (up to 5 days) | ms |
| Early Warning Score (EWS) to identify patients at risk of deterioration in hospital | Daily during admission (up to 5 days) | — |
| HbA1c to assess the average blood glucose levels 3 months before admission | Day 1 | — |
| Forced expiratory volume in 1 second (FEV1) during spirometry | Discharge (an average of 5 days) | Litre |
| Duration of the QRS complex out of the 12-lead resting ECG | Daily during admission (up to 5 days) | ms |
| FEV1% predicted during spirometry | Discharge (an average of 5 days) | — |
| Facal sample to assess changes in microbiome | Day 1, 1 month and 6 months | — |
| Urine samples to assess metabolomics | Day 1, 1 month and 6 months | — |
Countries
Denmark