Status:
COMPLETED
B-type Natriuretic Peptide for the Management of Weaning
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Dräger Médical S.A
Abbott RDx Cardiometabolic
Conditions:
Respiratory Insufficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
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 mecha...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
265 Patients enrolled
Trial Details
Trial ID
NCT00473148
Start Date
June 1 2007
End Date
March 1 2010
Last Update
April 30 2010
Active Locations (1)
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1
CHU Henri Mondor
Créteil, France, 94010