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

Community-acquired Pneumonia Clinical Trial

— 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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04071041
• Other study ID #: HUB-INF-ALBUCAP-402
• Secondary ID: 2018-003117-18PI
• Status: Terminated
• Phase: Phase 3
• Start date: October 31, 2019
• Est. completion date: October 31, 2021

Study information

• Verified date: January 2023
• Source: Hospital Universitari de Bellvitge
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Community-acquired Pneumonia
• Hypoalbuminemia
• Pneumonia

Intervention

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.

Locations

Country	Name	City	State
Spain	SCIAS-Hospital de Barcelona	Barcelona
Spain	Hospital Universitari de Bellvitge	Hospitalet de Llobregat	Barcelona
Spain	Hospital Residència Sant Camil	Sant Pere de Ribes	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Jordi Carratala	Institut d'Investigació Biomèdica de Bellvitge, Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Length of hospital stay (days).	The total length of hospital stay (measured in days)	Up to hospital discharge - a median of 10 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	All-cause mortality	5-day mortality, 30-day mortality and mortality within 30 days of hospital discharge.	Up to 30 ±5 days after discharge