Effect of Albumin Administration in Hypoalbuminemic Hospitalized Patients With Community-acquired Pneumonia. (ALBUCAP)

Effect of Albumin Administration on Outcomes in Hypoalbuminemic Patients Hospitalized With Community-acquired Pneumonia (ALBUCAP): a Prospective, Randomized, Phase III Clinical Controlled Trial.

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.

Study Overview

• Status: Unknown
• Conditions: Hypoalbuminemia; Community-acquired Pneumonia
• Intervention / Treatment: Drug: Albumin Human

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.

• Study Type: Interventional
• Enrollment (Anticipated): 360
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Alexander Rombauts; Phone Number: +34 932607625; Email: arombauts@bellvitgehospital.cat

Study Locations

• Spain
  • Barcelona, Spain, 08034
    • Recruiting
    • SCIAS-Hospital de Barcelona
    • Contact: Yolanda Meije, PhD; Email: yolandameije@gmail.com
  • Barcelona
    • Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Recruiting
      • Hospital Universitari de Bellvitge
      • Contact: Alexander Rombauts, MD; Phone Number: 0034 660434413; Email: arombauts@bellvitgehospital.cat
    • Sant Pere de Ribes, Barcelona, Spain, 08810
      • Recruiting
      • Hospital Residència Sant Camil
      • Contact: Antonella F Simonetti, PhD; Email: antonella.f.simonetti@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard care plus albumin; Patients will receive human 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. Patients will receive empirical antibiotic therapy according to guidelines as soon as CAP is confirmed. All microbiological assessments and additional treatment (e.g. oxygen, bronchodilators, corticosteroids, analgesic drugs, vasoactive agents, fluid resuscitation, and mechanical ventilation) will be at the discretion of the treating physicians (not the study investigators). The time of discharge and duration of antibiotics will not be determined by the study investigators, but by the treating physician team.	Drug: Albumin 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.; Other Names: Albutein
No Intervention: Standard care alone; Patients will receive empirical antibiotic therapy according to guidelines as soon as CAP is confirmed. All microbiological assessments and additional treatment (e.g. oxygen, bronchodilators, corticosteroids, analgesic drugs, vasoactive agents, fluid resuscitation, and mechanical ventilation) will be at the discretion of the treating physicians (not the study investigators). The time of discharge and duration of antibiotics will not be determined by the study investigators, but by the treating physician team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 5±1 of hospitalization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to clinical stability (days) measured from hospital admission	The time (days) to clinical stability, measured from hospital admission	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)	Up to 30 ±5 days after discharge
Length of hospital stay (days).	The total length of hospital stay (measured in days)	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	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	Up to hospital discharge - a median of 10 days
Proportion of adverse events.	Any adverse event, its severity and its possible relationship to the study drug will be assessed	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	Up to 30 ±5 days after discharge
All-cause mortality	5-day mortality, 30-day mortality and mortality within 30 days of hospital discharge.	Up to 30 ±5 days after discharge

Collaborators and Investigators

• Sponsor: Jordi Carratala
• Collaborators: Institut d'Investigació Biomèdica de Bellvitge; Instituto de Salud Carlos III
• Investigators: Principal Investigator: Alexander Rombauts, Institut d'Investigació Biomèdica de Bellvitge; Study Director: Jordi Carratalà, Hospital Universtari de Bellvitge, Universitat de Barcelona

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2019
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: July 31, 2019
• First Submitted That Met QC Criteria: August 26, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): March 5, 2020
• Last Update Submitted That Met QC Criteria: March 4, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Inflammation; Community-acquired Pneumonia; Albumin
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Hematologic Diseases; Blood Protein Disorders; Hypoproteinemia; Pneumonia; Hypoalbuminemia
• Other Study ID Numbers: HUB-INF-ALBUCAP-402; 2018-003117-18 (EudraCT Number); PI17/01332 (Other Grant/Funding Number: Instituto de Salud Carlos III)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No