Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00473148
Status:
COMPLETED
Last Update Posted:
2010-04-30
First Post:
2007-05-11
Brief Title:
B-type Natriuretic Peptide for the Management of Weaning
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Weaning of Mechanical Ventilation Guided by the Natriuretic Peptide of Type B
Status:
COMPLETED
Status Verified Date:
2008-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BMW
Brief Summary:
Several clinical findings and clinical trials have suggested that the prognosis of intensive care unit ICU patients may be improved by minimizing the positive fluid balance In particular a global vascular overload could lead to weaning failure The purpose of this international multicenter controlled randomized trial is to test if the incorporation of a B-type natriuretic peptide BNP assay in a mechanical ventilation weaning protocol helps optimize the weaning process and reduce the duration of the ventilatory weaning period
Detailed Description:
Mechanical ventilation may give rise to complications with an incidence that increases with the duration of respiratory support The purpose of the weaning procedure is to reduce the duration of mechanical ventilation without incurring a substantial risk of failure Several clinical findings and clinical trials have suggested that the prognosis of ICU patients may be improved by minimizing the positive fluid balance In particular a global vascular overload could lead to weaning failure B-type natriuretic peptide BNP is a hormone secreted by the ventricular cardiomyocytes in response to increased wall stretch and its plasma levels are correlated with left ventricular filling pressure In a preliminary study on 102 patients undergoing weaning from mechanical ventilation the baseline BNP levels before weaning were found to be an independent risk factor for weaning failure In surviving patients BNP levels were significantly correlated with the duration of weaning procedure The purpose of this international multicenter controlled randomized trial is to test if the incorporation of a BNP assay in a mechanical ventilation weaning protocol helps optimize the weaning process and reduce the duration of ventilatory weaning period Patients on mechanical ventilation presenting weaning criteria will be randomly assigned to two groups standard physician-directed weaning or weaning guided by BNP assay In order to standardize the weaning process patients will be ventilated with an automatic computer-driven weaning system in the two groups EVITA Smart Care System Drager Medical A blood sample will be collected from all patients every morning for BNP assay by the rapid immunofluorescence test Triage BNP Test BIOSITE In the control group the clinician will not be informed about the assay results and weaning will be carried out according to usual practices Patients in the intervention group will receive diuretics according to a clinical practice algorithm based on plasma BNP levels and a fluid intake restriction The primary endpoint for the two groups will be duration of weaning from mechanical ventilation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None