B-Type Natriuretic Peptide for the Management of Weaning - Full Text View

Sponsors and Collaborators:	Assistance Publique - Hôpitaux de Paris Dräger Médical S.A Biosite
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00473148

Purpose

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

U.S. FDA Resources

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

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

Duration of weaning from invasive ventilation [ Time Frame: during ventilation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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

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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 exclusion criteria:

Pregnancy or lactation
Age < 18 years
Known allergy to furosemide or sulphonamides
Tracheotomy on inclusion
Hepatic encephalopathy
Cerebral edema, acute hydrocephaly
Myasthenia gravis or acute idiopathic polyradiculoneuritis (Guillain-Barré syndrome)
Decision to withdraw life support
Prolonged cardiac arrest with poor neurological prognosis

II: Temporary exclusion criteria:

Extubation of the patient programmed for the same day
Acute right ventricular insufficiency (pulmonary embolism, right myocardial infarction)
Renal insufficiency defined by one of the following: renal replacement therapy, or plasma urea > 25 mmol/L, or plasma creatinine > 180 µmol/L, or creatinine clearance < 30 mL/min or increase by more than 25% of plasma creatinine during the previous 24 hours
One of the following metabolic abnormalities: blood sodium > 150 mEq/L; blood potassium < 3.5 mEq/L; metabolic alkalosis with arterial pH > 7.50
Injection of iodinated contrast agent during the preceding six hours

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00473148

Contacts

Contact: Armand Mekonto Dessap, MD

+33(0) 1 49 81 23 91

armand.dessap@hmn.aphp.fr

Locations

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

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Dräger Médical S.A

Biosite

Investigators

Principal Investigator:

Armand Mekonto Dessap, MD

Assistance Publique - Hôpitaux de Paris

More Information

No publications provided

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

Keywords provided by Assistance Publique - Hôpitaux de Paris:

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

Study placed in the following topic categories:

Natriuretic Peptide, Brain
Respiratory Insufficiency
Respiratory Tract Diseases

Diuretics
Respiration Disorders
Cardiovascular Agents

Additional relevant MeSH terms:

Natriuretic Peptide, Brain
Respiratory Insufficiency
Respiratory Tract Diseases
Natriuretic Agents
Therapeutic Uses

Physiological Effects of Drugs
Respiration Disorders
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 06, 2009