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

Primary Purpose

Community-acquired Pneumonia, Hypoalbuminemia

Status

Terminated

Phase

Phase 3

Locations

Spain

Study Type

Interventional

Intervention

Albumin Human

About this trial

This is an interventional treatment trial for Community-acquired Pneumonia focused on measuring Community-acquired Pneumonia, Albumin, Inflammation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hospital Universitari de Bellvitge
Hospital Residència Sant Camil
SCIAS-Hospital de Barcelona

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Standard care plus albumin

Standard care alone

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time to clinical stability (days) measured from hospital admission

The time (days) to clinical stability, measured from hospital admission

Duration of intravenous and total antibiotic treatment (days).

The duration of intravenous and total duration of antibiotic treatment (measured in days)

Length of hospital stay (days).

The total length of hospital stay (measured in 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

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

Proportion of adverse events.

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

We will document hospital readmission within 30 days of discharge

All-cause mortality

5-day mortality, 30-day mortality and mortality within 30 days of hospital discharge.

Full Information

NCT ID

NCT04071041

First Posted

July 31, 2019

Last Updated

January 27, 2023

Sponsor

Jordi Carratala

Collaborators

Instituto de Salud Carlos III, Institut d'Investigació Biomèdica de Bellvitge

1. Study Identification

Unique Protocol Identification Number

NCT04071041

Brief Title

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

Acronym

ALBUCAP

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

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Terminated

Why Stopped

Low recruitment

Study Start Date

October 31, 2019 (Actual)

Primary Completion Date

October 31, 2021 (Actual)

Study Completion Date

October 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Jordi Carratala

Collaborators

Instituto de Salud Carlos III, Institut d'Investigació Biomèdica de Bellvitge

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Community-acquired Pneumonia, Hypoalbuminemia

Keywords

Community-acquired Pneumonia, Albumin, Inflammation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard care plus albumin

Arm Type

Experimental

Arm Description

Arm Title

Standard care alone

Arm Type

No Intervention

Arm Description

Intervention Type

Drug

Intervention Name(s)

Albumin Human

Other Intervention Name(s)

Albutein

Intervention Description

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.

Primary Outcome Measure Information:

Title

The proportion of clinical stable patients at day 5, measured from hospital admission.

Description

Time Frame

Day 5±1 of hospitalization

Secondary Outcome Measure Information:

Title

Time to clinical stability (days) measured from hospital admission

Description

The time (days) to clinical stability, measured from hospital admission

Time Frame

Up to 30 ±5 days after discharge

Title

Duration of intravenous and total antibiotic treatment (days).

Description

The duration of intravenous and total duration of antibiotic treatment (measured in days)

Time Frame

Up to 30 ±5 days after discharge

Title

Length of hospital stay (days).

Description

The total length of hospital stay (measured in days)

Time Frame

Up to hospital discharge - a median of 10 days

Title

Proportion of patients with intensive care unit (ICU) admission.

Description

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

Title

The rate of nosocomial infection during hospitalization

Description

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

Title

Proportion of adverse events.

Description

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

Title

The number of patients with hospital readmission within 30 days of discharge

Description

We will document hospital readmission within 30 days of discharge

Time Frame

Up to 30 ±5 days after discharge

Title

All-cause mortality

Description

5-day mortality, 30-day mortality and mortality within 30 days of hospital discharge.

Time Frame

Up to 30 ±5 days after discharge

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexander Rombauts

Organizational Affiliation

Institut d'Investigació Biomèdica de Bellvitge

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jordi Carratalà

Organizational Affiliation

Hospital Universtari de Bellvitge, Universitat de Barcelona

Official's Role

Study Director

Facility Information:

Facility Name

Hospital Universitari de Bellvitge

City

Hospitalet de Llobregat

State/Province

Barcelona

ZIP/Postal Code

08907

Country

Spain

Facility Name

Hospital Residència Sant Camil

City

Sant Pere de Ribes

State/Province

Barcelona

ZIP/Postal Code

08810

Country

Spain

Facility Name

SCIAS-Hospital de Barcelona

City

Barcelona

ZIP/Postal Code

08034

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32819439

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.

Results Reference

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

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