Clinical trial NCT04071041: Effect of Albumin Administration in Hypoalbuminemic Hospitalized Patients With Community-acquired Pneumonia.
Official title: Effect of Albumin Administration on Outcomes in Hypoalbuminemic Patients Hospitalized With Community-acquired Pneumonia (ALBUCAP): a Prospective, Randomized, Phase III Clinical Controlled Trial.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Community-acquired Pneumonia
Hypoalbuminemia
Keywords: Community-acquired Pneumonia
Albumin
Inflammation
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
name: Institut d'Investigació Biomèdica de Bellvitge
First posted: 2019-08-28
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The proportion of clinical stable patients at day 5, measured from hospital admission.
timeFrame: Day 5±1 of hospitalization
Secondary outcomes:
measure: Time to clinical stability (days) measured from hospital admission
timeFrame: Up to 30 ±5 days after discharge
measure: Duration of intravenous and total antibiotic treatment (days).
timeFrame: Up to 30 ±5 days after discharge
measure: Length of hospital stay (days).
timeFrame: Up to hospital discharge - a median of 10 days
measure: Proportion of patients with intensive care unit (ICU) admission.
timeFrame: Up to hospital discharge - a median of 10 days
measure: The rate of nosocomial infection during hospitalization
timeFrame: Up to hospital discharge - a median of 10 days
measure: Proportion of adverse events.
timeFrame: Up to 30 ±5 days after discharge
measure: The number of patients with hospital readmission within 30 days of discharge
timeFrame: Up to 30 ±5 days after discharge
measure: All-cause mortality
timeFrame: Up to 30 ±5 days after discharge
Other outcomes:
Locations:
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
city: Sant Pere de Ribes
country: Spain
facility: Hospital Residència Sant Camil
state: Barcelona
city: Barcelona
country: Spain
facility: SCIAS-Hospital de Barcelona
Study officials:
affiliation: Institut d'Investigació Biomèdica de Bellvitge
name: Alexander Rombauts
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universtari de Bellvitge, Universitat de Barcelona
name: Jordi Carratalà
role: STUDY_DIRECTOR
References:
citation: Rombauts A, Abelenda-Alonso G, Simonetti AF, Verdejo G, Meije Y, Ortega L, Clemente M, Niubo J, Ruiz Y, Gudiol C, Tebe C, Videla S, Carratala J. Effect of albumin administration on outcomes in hypoalbuminemic patients hospitalized with community-acquired pneumonia (ALBUCAP): a prospective, randomized, phase III clinical controlled trial-a trial protocol. Trials. 2020 Aug 20;21(1):727. doi: 10.1186/s13063-020-04627-1.