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

• Status: Recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jordi Carratala
• Collaborators: Institut d'Investigació Biomèdica de Bellvitge; Instituto de Salud Carlos III

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.