Community-acquired Pneumonia, Hypoalbuminemia
Conditions
Keywords
Community-acquired Pneumonia, Albumin, Inflammation
Brief summary
Community-acquired pneumonia (CAP) remains a leading cause of death world-wide. Hypoalbuminemia is associated with worse outcomes. However, whether albumin administration would have a beneficial effect in outcome in patients with CAP remains uncertain. This project proposes to test the hypothesis of whether the administration of albumin in hypoalbuminemic patients with CAP would increase the proportion of clinical stable patients at day 5.
Detailed description
This project will consist of a superiority, non-blinded, multicentre, randomized, phase 3, interventional controlled clinical trial. The estimated sample size is of 360 patients, who will be recruited from three Spanish hospitals. Hypoalbuminemic (≤30g/L) adult patients with CAP will be randomly assigned (1:1) to receive standard care plus albumin (20g in 100ml) every 12 hours for 4 days or standard care alone. The primary endpoint will be the proportion of clinical stable patients at day 5, defined as stable vital signs for at least 24h, analyzed by intention to treat. The secondary endpoints will be time to clinical stability; duration of intravenous and total antibiotic treatment; length of hospital stay; intensive care unit admission; duration of mechanical ventilation and vasopressor treatment; adverse events; readmission within 30 days and all-cause mortality.
Interventions
DRUGAlbumin Human
Administration of albumin 20%, 20g in 100ml (Albutein Instituto Grifols, S.A. Can Guasch 2, Parets del Vallès, 08015 Barcelona, Spain) intravenously every 12 hours for 4 days or until death, discharge or clinical stability if occurring before.
Sponsors
Instituto de Salud Carlos III
Institut d'Investigació Biomèdica de Bellvitge
Jordi Carratala
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A superiority, non-blinded, multicentre, randomized, interventional controlled clinical trial. Patients will be randomly assigned (1:1) to receive standard of care plus albumin (20g in 100ml) every 12 hours for 4 days or standard of care alone.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years. * Diagnosis of CAP (Chest radiography consistent with CAP AND the presence of ≥2 following prespecified clinical criteria: Fever or hypothermia; Cough; Purulent sputum; High white blood cell count; Dyspnea; Pleuritic chest pain; Signs consistent with pneumonia on chest auscultation) * Serum albumin concentration ≤ 30 g/L at presentation
Exclusion criteria
* Pregnancy or lactation * Immunosuppression (e.g. chemotherapy or radiotherapy within 90 days, immunosuppressive drugs, corticosteroids at a minimum dose of 15mg/day of prednisone within 2 weeks of enrolment, HIV with a CD4 count below 200, solid organ transplant recipients, hematopoietic cell transplant recipients). * Severe clinical status with expected survival of less than 24h. * Congestive heart failure (New York Heart Association classes 3 or 4) * Any contraindication for albumin administration such as hypersensitivity to albumin. * Clinical conditions in which there is another indication for albumin administration (e.g. hepatic cirrhosis with ascites, malabsorption syndrome and nephrotic syndrome). * Absence or impossibility of obtaining informed consent from the patient/next of kin. * Patient already included in another clinical trial testing a treatment method.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of clinical stable patients at day 5, measured from hospital admission. | Day 5±1 of hospitalization | Clinical stability will be defined as achieving normal oral intake, normal mental status (or usual level of functioning) and stable vital signs for at least 24 h, as previously described by Halm et al 1998 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of intravenous and total antibiotic treatment (days). | Up to 30 ±5 days after discharge | The duration of intravenous and total duration of antibiotic treatment (measured in days) |
| Length of hospital stay (days). | Up to hospital discharge - a median of 10 days | The total length of hospital stay (measured in days) |
| Proportion of patients with intensive care unit (ICU) admission. | Up to hospital discharge - a median of 10 days | The number of patients admitted to intensive care. For those admitted to ICU we will record: time to discharge from ICU; duration of vasopressor treatment; duration of mechanical ventilation |
| Time to clinical stability (days) measured from hospital admission | Up to 30 ±5 days after discharge | The time (days) to clinical stability, measured from hospital admission |
| Proportion of adverse events. | Up to 30 ±5 days after discharge | Any adverse event, its severity and its possible relationship to the study drug will be assessed |
| The number of patients with hospital readmission within 30 days of discharge | Up to 30 ±5 days after discharge | We will document hospital readmission within 30 days of discharge |
| All-cause mortality | Up to 30 ±5 days after discharge | 5-day mortality, 30-day mortality and mortality within 30 days of hospital discharge. |
| The rate of nosocomial infection during hospitalization | Up to hospital discharge - a median of 10 days | The proportion of patients with nosocomial infection during hospitalization will be registered, the type of nosocomial infection will be described |
Countries
Spain
Outcome results
None listed