Clinical Trial: B-type Natriuretic Peptide for the Management of Weaning

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Weaning of Mechanical Ventilation Guided by the Natriuretic Peptide of Type B

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 Summary: 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 bas
Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: Duration of weaning from invasive ventilation [ Time Frame: during ventilation ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Total duration of weaning from invasive and noninvasive ventilation [ Time Frame: during hospitalisation ]
  • Total duration of mechanical ventilation [ Time Frame: during 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 rates [ Time Frame: during hospitalisation in ICU ]
  • Cost of stay in the ICU [ Time Frame: in the ICU ]
  • Cost of stay in hospital [ Time Frame: during the all stay ]
  • Mortality in ICU [ Time Frame: in ICU ]
  • Mortality sixty days after randomization [ Time Frame: sixty days after randomization ]


Original Secondary Outcome: Same as current

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: May 11, 2007
Date Started: June 2007
Date Completion:
Last Updated: April 29, 2010
Last Verified: November 2008