- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00473148
B-type Natriuretic Peptide for the Management of Weaning (BMW)
April 29, 2010 updated by: Assistance Publique - Hôpitaux de Paris
Weaning of Mechanical Ventilation Guided by the Natriuretic Peptide of Type B
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
265
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Creteil, France, 94010
- CHU Henri Mondor
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: 2
|
Standard physician-directed weaning
|
Experimental: 1
BNP-guided treatment (Furosemide)
|
BNP-guided weaning
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Duration of weaning from invasive ventilation
Time Frame: during ventilation
|
during ventilation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Total duration of weaning from invasive and noninvasive ventilation
Time Frame: during hospitalisation
|
during hospitalisation
|
Total duration of mechanical ventilation
Time Frame: during hospitalisation
|
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
|
during hospitalisation in ICU
|
Cost of stay in the ICU
Time Frame: in the ICU
|
in the ICU
|
Cost of stay in hospital
Time Frame: during the all stay
|
during the all stay
|
Mortality in ICU
Time Frame: in ICU
|
in ICU
|
Mortality sixty days after randomization
Time Frame: sixty days after randomization
|
sixty days after randomization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Armand Mekonto Dessap, MD, Assistance Publique - Hôpitaux de Paris
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Dessap AM, Roche-Campo F, Launay JM, Charles-Nelson A, Katsahian S, Brun-Buisson C, Brochard L. Delirium and Circadian Rhythm of Melatonin During Weaning From Mechanical Ventilation: An Ancillary Study of a Weaning Trial. Chest. 2015 Nov;148(5):1231-1241. doi: 10.1378/chest.15-0525.
- Mekontso Dessap A, Katsahian S, Roche-Campo F, Varet H, Kouatchet A, Tomicic V, Beduneau G, Sonneville R, Jaber S, Darmon M, Castanares-Zapatero D, Brochard L, Brun-Buisson C. Ventilator-associated pneumonia during weaning from mechanical ventilation: role of fluid management. Chest. 2014 Jul;146(1):58-65. doi: 10.1378/chest.13-2564.
- Mekontso Dessap A, Roche-Campo F, Kouatchet A, Tomicic V, Beduneau G, Sonneville R, Cabello B, Jaber S, Azoulay E, Castanares-Zapatero D, Devaquet J, Lellouche F, Katsahian S, Brochard L. Natriuretic peptide-driven fluid management during ventilator weaning: a randomized controlled trial. Am J Respir Crit Care Med. 2012 Dec 15;186(12):1256-63. doi: 10.1164/rccm.201205-0939OC. Epub 2012 Sep 20.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
May 11, 2007
First Submitted That Met QC Criteria
May 11, 2007
First Posted (Estimate)
May 14, 2007
Study Record Updates
Last Update Posted (Estimate)
April 30, 2010
Last Update Submitted That Met QC Criteria
April 29, 2010
Last Verified
November 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P051018
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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