Ignite Creation Date:
2024-05-06 @ 1:38 PM
Last Modification Date:
2024-10-26 @ 1:17 PM
Study NCT ID:
NCT04071041
Status:
TERMINATED
Last Update Posted:
2023-01-31
First Post:
2019-07-31
Brief Title:
Effect of Albumin Administration in Hypoalbuminemic Hospitalized Patients With Community-acquired Pneumonia
Sponsor:
Jordi Carratala
Organization:
Hospital Universitari de Bellvitge
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALBUCAP
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
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 30gL adult patients with CAP will be randomly assigned 11 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-003117-18 | EUDRACT_NUMBER | None | None |
| PI1701332 | OTHER_GRANT | Instituto de Salud Carlos III | None |