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Sponsors and Collaborators: |
Assistance Publique - Hôpitaux de Paris Dräger Médical S.A Biosite |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00473148 |
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.
Condition | Intervention | Phase |
---|---|---|
Respiratory Insufficiency |
Procedure: BNP-guided weaning Procedure: Standard physician-directed weaning |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Weaning of Mechanical Ventilation Guided by the Natriuretic Peptide of Type B |
Estimated Enrollment: | 375 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | August 2010 |
Arms | Assigned Interventions |
---|---|
1: Experimental
BNP-guided treatment (Furosemide)
|
Procedure: BNP-guided weaning
BNP-guided weaning
|
2: No Intervention |
Procedure: Standard physician-directed weaning
Standard physician-directed weaning
|
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
I: Definite exclusion criteria:
II: Temporary exclusion criteria:
Contact: Armand Mekonto Dessap, MD | +33(0) 1 49 81 23 91 | armand.dessap@hmn.aphp.fr |
France | |
CHU Henri Mondor | Recruiting |
Creteil, France, 94010 | |
Contact: Armand Mekonto Dessap, MD +33(0) 1 49 81 23 91 armand.dessap@hmn.aphp.fr |
Principal Investigator: | Armand Mekonto Dessap, MD | Assistance Publique - Hôpitaux de Paris |
Responsible Party: | Department of Clinical Research and Development ( Christophe AUCAN: Manager ) |
Study ID Numbers: | P051018, AOM05104 |
Study First Received: | May 11, 2007 |
Last Updated: | November 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00473148 History of Changes |
Health Authority: | France: Ministry of Health |
Duration of weaning from invasive ventilation Mechanical ventilation Weaning B-type natriuretic peptide Fluid balance |
Diuretics Intubated patient receiving mechanical ventilation for at least 24 hours Respiratory insufficiency |
Natriuretic Peptide, Brain Respiratory Insufficiency Respiratory Tract Diseases |
Diuretics Respiration Disorders Cardiovascular Agents |
Natriuretic Peptide, Brain Respiratory Insufficiency Respiratory Tract Diseases Natriuretic Agents Therapeutic Uses |
Physiological Effects of Drugs Respiration Disorders Cardiovascular Agents Pharmacologic Actions |