Status:
TERMINATED
Effect of Albumin Administration in Hypoalbuminemic Hospitalized Patients With Community-acquired Pneumonia.
Lead Sponsor:
Jordi Carratala
Collaborating Sponsors:
Instituto de Salud Carlos III
Institut d'Investigació Biomèdica de Bellvitge
Conditions:
Community-acquired Pneumonia
Hypoalbuminemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 effec...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2021
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT04071041
Start Date
October 31 2019
End Date
October 31 2021
Last Update
January 31 2023
Active Locations (3)
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1
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
2
Hospital Residència Sant Camil
Sant Pere de Ribes, Barcelona, Spain, 08810
3
SCIAS-Hospital de Barcelona
Barcelona, Spain, 08034