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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003117-18 | EudraCT Number | ||
| PI17/01332 | Other Grant/Funding Number | Instituto de Salud Carlos III |
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Low recruitment
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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
| Institut d'Investigació Biomèdica de Bellvitge | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard care plus albumin | Experimental | 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. |
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| Standard care alone | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albumin Human | Drug | 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. |
| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Rombauts | Institut d'Investigació Biomèdica de Bellvitge | Principal Investigator |
| Jordi Carratalà | Hospital Universtari de Bellvitge, Universitat de Barcelona | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari de Bellvitge | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain | ||
| Hospital Residència Sant Camil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32819439 | Derived | 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. |
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| ID | Term |
|---|---|
| D000098968 | Community-Acquired Pneumonia |
| D034141 | Hypoalbuminemia |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D017714 | Community-Acquired Infections |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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| ID | Term |
|---|---|
| D000075462 | Serum Albumin, Human |
| D000418 | Albumins |
| ID | Term |
|---|---|
| D012709 | Serum Albumin |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001798 | Blood Proteins |
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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.
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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 |
| Sant Pere de Ribes |
| Barcelona |
| 08810 |
| Spain |
| SCIAS-Hospital de Barcelona | Barcelona | 08034 | Spain |
| D012140 |
| Respiratory Tract Diseases |
| D007019 | Hypoproteinemia |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |