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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
39
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.
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Residència Sant Camil
Sant Pere de Ribes, Barcelona, Spain
SCIAS-Hospital de Barcelona
Barcelona, Spain
The proportion of clinical stable patients at day 5, measured from hospital admission.
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
Time frame: Day 5±1 of hospitalization
Time to clinical stability (days) measured from hospital admission
The time (days) to clinical stability, measured from hospital admission
Time frame: Up to 30 ±5 days after discharge
Duration of intravenous and total antibiotic treatment (days).
The duration of intravenous and total duration of antibiotic treatment (measured in days)
Time frame: Up to 30 ±5 days after discharge
Length of hospital stay (days).
The total length of hospital stay (measured in days)
Time frame: Up to hospital discharge - a median of 10 days
Proportion of patients with intensive care unit (ICU) admission.
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 frame: Up to hospital discharge - a median of 10 days
The rate of nosocomial infection during hospitalization
The proportion of patients with nosocomial infection during hospitalization will be registered, the type of nosocomial infection will be described
Time frame: Up to hospital discharge - a median of 10 days
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Proportion of adverse events.
Any adverse event, its severity and its possible relationship to the study drug will be assessed
Time frame: Up to 30 ±5 days after discharge
The number of patients with hospital readmission within 30 days of discharge
We will document hospital readmission within 30 days of discharge
Time frame: Up to 30 ±5 days after discharge
All-cause mortality
5-day mortality, 30-day mortality and mortality within 30 days of hospital discharge.
Time frame: Up to 30 ±5 days after discharge