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B-type Natriuretic Peptide for the Management of Weaning

Weaning of Mechanical Ventilation Guided by the Natriuretic Peptide of Type B

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00473148
Acronym
BMW
Enrollment
265
Registered
2007-05-14
Start date
2007-06-30
Completion date
2010-03-31
Last updated
2010-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Insufficiency

Keywords

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

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.

Interventions

PROCEDUREBNP-guided weaning

BNP-guided weaning

PROCEDUREStandard physician-directed weaning

Standard physician-directed weaning

Sponsors

Dräger Médical S.A
CollaboratorUNKNOWN
Abbott RDx Cardiometabolic
CollaboratorOTHER
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Intubated patient receiving mechanical ventilation for at least 24 hours * SpO2 ≥ 90% with FiO2 ≤ 50% and PEP ≤ 8 cm H2O * Hemodynamic stability without vasopressor therapy (dopamine ≤ 10 γ/kg/min and dobutamine ≤ 10 γ/kg/min are however allowed) nor fluid bolus (rapid infusion of at least 500 ml of macromolecules or 1000 ml of saline) during the twelve previous hours * Sedation stopped or reduced during the previous 48 hours (analgesia may be continued) * Stable neurological status with Ramsay score ≤ 5 * Body temperature \> 36.0 °C and \< 39 °C * Informed consent signed by patient or close relative

Exclusion criteria

I: Definite

Design outcomes

Primary

MeasureTime frame
Duration of weaning from invasive ventilationduring ventilation

Secondary

MeasureTime frame
Total duration of mechanical ventilationduring hospitalisation
Length of stay in the ICU, length of stay in hospital, number of complications in intensive care, number of prolonged weanings (> 15 days), number of cases of nosocomial pneumonia, number of successful extubations, extubation complication ratesduring hospitalisation in ICU
Cost of stay in the ICUin the ICU
Total duration of weaning from invasive and noninvasive ventilationduring hospitalisation
Mortality in ICUin ICU
Mortality sixty days after randomizationsixty days after randomization
Cost of stay in hospitalduring the all stay

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026