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Surviving Pneumonia

Surviving Pneumonia

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03795662
Enrollment
2500
Registered
2019-01-08
Start date
2019-01-07
Completion date
2038-12-31
Last updated
2021-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Community-acquired Pneumonia

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

OTHERNo intervention

Obervational

Sponsors

Nordsjaellands Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Number of death from any causesFrom date of admission until the day of death from any causes, up to 24 monthsAssessed through patient files
Number of participants who develop diabetesUp to 24 monthsAssessed through patient files and the national registers

Secondary

MeasureTime frameDescription
Length of hospital stayParticipants will be followed for the duration of hospital stay, an expected average of 5 daysThrough patient files
Oral glucose tolerance testDay 1, discharge (an average of 5 days), 1 month and 6-month
Number of participants who are readmittedUp to 6 monthsThrough patient files

Other

MeasureTime frameDescription
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)
BMIDay 1, discharge (an average of 5 days), 1 month and 6 monthsWeight (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 monthsBlood 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 monocytesDay 1 and discharge (an average of 5 days)Flow cytometry on whole blood
Concentration of blood lipidsDay 1, discharge (an average of 5 days), 1 month and 6 monthsBlood sampling
Scoring of the Charlson Comorbidity Index to predict 10-year survivalDay 1Scale 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 testDay 1, discharge (an average of 5 days), 1 month and 6 months
Glucagon concentration during oral glucose tolerance testDay 1, discharge (an average of 5 days), 1 month and 6 monthsBlood sampling
Insulin concentration during oral glucose tolerance testDay 1, discharge (an average of 5 days), 1 month and 6 monthsBlood sampling
C-peptide concentration during oral glucose tolerance testDay 1, discharge (an average of 5 days), 1 month and 6 monthsBlood sampling
GLP-1 concentration during oral glucose tolerance testDay 1, discharge (an average of 5 days), 1 month and 6 monthsBlood sampling
GLP-2 concentration during oral glucose tolerance testDay 1, discharge (an average of 5 days), 1 month and 6 monthsBlood sampling
GIP concentration during oral glucose tolerance testDay 1, discharge (an average of 5 days), 1 month and 6 monthsBlood sampling
Insulin sensitivity index (Matsuda) based on oral glucose tolerance testDay 1, discharge (an average of 5 days), 1 month and 6 months
Insulin secretion index based on oral glucose tolerance testDay 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 monthsBlood sampling
Concentration of NT-proBNP (ng/l)Daily during admission, 1 month and 6 monthsBlood sampling
Chest x-ray to image inflammation of the lungsOn admission, 1 month and 6 months
Z-value of left ventricle (LV) out of echocardiographyDischarge (an average of 5 days), 1 month and 6 monthsZ-value LV
Z-value of right ventricle (RV) out of echocardiographyDischarge (an average of 5 days), 1 month and 6 monthsZ-value RV
Z-value of left atrium (LA) out of echocardiographyDischarge (an average of 5 days), 1 month and 6 monthsZ-value LA
Shortening fraction (SF) measured in echocardiographyDischarge (an average of 5 days), 1 month and 6 monthsSF (%)
Ejection fraction (EF) measured in echocardiographyDischarge (an average of 5 days), 1 month and 6 monthsEF (%)
Valvular insufficiency measured in echocardiographyDischarge (an average of 5 days), 1 month and 6 monthsAorta valve regurgitation, pulmonary valve regurgitation, tricuspid valve regurgitation and mitral valve regurgitation (no, minimal, moderate, severe)
Heart rate of 12-lead resting ECGDaily during admission (up to 5 days)bpm
Rhythm during 12-lead resting ECGDaily during admission (up to 5 days)Sinus rhythm yes/no
Axis of the QRS complex out of the 12-lead resting ECGDaily during admission (up to 5 days)Degree
Number of cardiac eventsFrom date of admission up to 24 monthsAssessed 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 contentOn admission, 1 month and 6 months
Forced vital capacity (FVC) during spirometryDischarge (an average of 5 days)Litre
Duration of PQ interval out of the 12-lead resting ECGDaily during admission (up to 5 days)ms
Early Warning Score (EWS) to identify patients at risk of deterioration in hospitalDaily during admission (up to 5 days)
HbA1c to assess the average blood glucose levels 3 months before admissionDay 1
Forced expiratory volume in 1 second (FEV1) during spirometryDischarge (an average of 5 days)Litre
Duration of the QRS complex out of the 12-lead resting ECGDaily during admission (up to 5 days)ms
FEV1% predicted during spirometryDischarge (an average of 5 days)
Facal sample to assess changes in microbiomeDay 1, 1 month and 6 months
Urine samples to assess metabolomicsDay 1, 1 month and 6 months

Countries

Denmark

Contacts

Primary ContactCamilla Ryrsø, MSc
camilla.koch.ryrsoe.01@regionh.dk+4548293250
Backup ContactMaria Hegelund, MSc
maria.hein.hegelund.01@regionh.dk+4548293250

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 24, 2026