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Brain Natriuretic Peptide (BNP) Levels in Patients in Non Invasive Mechanical Ventilation
This study is currently recruiting participants.
Verified by Ospedale S. Giovanni Bosco, August 2009
First Received: March 28, 2007   Last Updated: August 5, 2009   History of Changes
Sponsored by: Ospedale S. Giovanni Bosco
Information provided by: Ospedale S. Giovanni Bosco
ClinicalTrials.gov Identifier: NCT00453726
  Purpose

The purpose of the study is to evaluate variation of BNP in non invasive mechanical ventilated patients with severe acute respiratory failure.


Condition Intervention Phase
Respiratory Insufficiency
Procedure: Non invasive mechanical ventilation
Phase IV

Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Evaluation of BNP in Patients With Severe Acute Respiratory Failure Requiring Non Invasive Mechanical Ventilation

Further study details as provided by Ospedale S. Giovanni Bosco:

Estimated Enrollment: 40
Study Start Date: May 2006
Intervention Details:
    Procedure: Non invasive mechanical ventilation
    .
Detailed Description:

The aim of the study is to evaluate in patients with severe acute respiratory failure requiring non invasive mechanical ventilation BNP levels at admission and during the following 24 hours during non invasive mechanical ventilation (Non Invasive Positive Pressure Ventilation or Continuous positive airway pressure).

Because in patients affected by acute respiratory failure it is often difficult to distinguish if the disease precipitating the respiratory failure is a cardiac disease or a lung disease, aim of the present study is to evaluate the discriminating role that BNP could have in this group of patients; evaluation will be completed, once obtained clinical stabilisation, with an echocardiography and respiratory functional test.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients of the city of Torino, admitted to the emergency department for acute respiratory failure.

Criteria

Inclusion Criteria:

  • Severe respiratory distress (use of respiratory accessory muscles);
  • Respiratory rate > 25 per minute;
  • Respiratory acidosis (pH < 7.35 and PaCO2 > 45 mmHg);
  • PaO2/FiO2 < 250

Exclusion Criteria:

  • Age < 18 years;
  • Facial deformities;
  • Pneumothorax;
  • Shock or systolic arterial pressure below 90 mmHg with amine infusion;
  • Life-threatening arrhythmias;
  • Need for immediate endotracheal intubation (PaO2/FiO2 < 100 with FiO2 100%, respiratory rate < 10, GCS < 8);
  • Lack of co-operation from the patient;
  • Recent esophageal-gastric surgery;
  • Inability to clear secretions;
  • Drugs that may interfere with BNP secretion;
  • Severe obesity;
  • Hepatic cirrhosis with ascitis;
  • Endocrine disease.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00453726

Contacts
Contact: Giovanni Ferrari, MD +39 011 2402240 giovanni_ferrari@fastwebnet.it
Contact: Franco Aprà, MD +39 011 2402240 francoapra@tiscali.it

Locations
Italy, Piedmont
Ospedale San Giovanni Bosco Medicina d'Urgenza Recruiting
Torino, Piedmont, Italy, 10154
Contact: Giovanni Ferrari, MD     +39 011 2402240     giovanni_ferrari@fastwebnet.it    
Contact: Franco Aprà, MD     +39 011 2402240     francoapra@tiscali.it    
Principal Investigator: Giovanni Ferrari, MD            
Sponsors and Collaborators
Ospedale S. Giovanni Bosco
Investigators
Principal Investigator: Giovanni Ferrari, MD Ospedale San Giovanni Bosco ASL4 Torino Italy
  More Information

No publications provided

Responsible Party: ASL TO4 Ospedale S. Giovanni Bosco ( Giovanni Ferrari )
Study ID Numbers: gbosco3
Study First Received: March 28, 2007
Last Updated: August 5, 2009
ClinicalTrials.gov Identifier: NCT00453726     History of Changes
Health Authority: Italy: Ministry of Health

Keywords provided by Ospedale S. Giovanni Bosco:
Natriuretic peptide brain
Continuous positive airway pressure
Intermittent positive pressure breathing
Respiratory insufficiency

Study placed in the following topic categories:
Natriuretic Peptide, Brain
Respiratory Insufficiency
Respiratory Tract Diseases
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 September 10, 2009