B-type Natriuretic Peptide for the Management of Weaning

NCT00473148 | Completed Phase 3

• 1 other identifier: P051018
• Study Type: interventional
• Target: 265
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Duration of weaning from invasive ventilation

  during ventilation

Secondary Outcomes (7)

• Total duration of weaning from invasive and noninvasive ventilation

  during hospitalisation

• Total duration of mechanical ventilation

  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

  during hospitalisation in ICU

• Cost of stay in the ICU

  in the ICU

• Cost of stay in hospital

  during the all stay

Study Arms (2)

1

EXPERIMENTAL

BNP-guided treatment (Furosemide)

Procedure: BNP-guided weaning

2

NO INTERVENTION

Procedure: Standard physician-directed weaning

Interventions

BNP-guided weaning PROCEDURE

BNP-guided weaning

1

Standard physician-directed weaning PROCEDURE

Standard physician-directed weaning

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy or lactation
• Age \< 18 years
• Known allergy to furosemide or sulphonamides
• 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
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Dräger Médical S.A: collaborator
• Abbott RDx Cardiometabolic: collaborator

Study Sites (1)

CHU Henri Mondor

Créteil, 94010, France

Location

Related Publications (3)

• 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.

  PMID: 26158245 DERIVED

• 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.

  PMID: 24652410 DERIVED

• 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.

  PMID: 22997204 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Armand Mekonto Dessap, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 11, 2007
• First Posted: May 14, 2007
• Study Start: June 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: April 30, 2010

Record last verified: 2008-11

Locations

FR (1)