Extracorporeal CO2 Removal in COPD Exacerbation (DECOPD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marco Ranieri, University of Turin, Italy
ClinicalTrials.gov Identifier:
NCT01422681
First received: August 5, 2011
Last updated: January 20, 2014
Last verified: January 2014
  Purpose

The minimally invasive extracorporeal carbon dioxide removal may decrease the respiratory load during chronic obstructive pulmonary disease (COPD) exacerbation, reducing the need to advance the respiratory care toward invasive mechanical ventilation in patients refractory to non-invasive ventilatory support (NIV), or decreasing the need of ventilatory support in patients already invasively ventilated, thereby accelerating the weaning process.

The investigators intend to perform a multi-center experimental non randomized single arm prospective study to investigate the efficacy of the Decap Smart in reducing the intubation rate or the duration of invasive mechanical ventilation in patients with COPD treated either with NIV or invasive mechanical ventilation (IMV) for severe respiratory failure and hypercapnia. The results of the study will be compared to the data available in the literature.


Condition Intervention Phase
COPD Exacerbation
Device: minimally invasive extracorporeal carbon dioxide removal
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Extracorporeal Carbon Dioxide Removal in Patients With Severe COPD Exacerbation Failing Noninvasive Ventilation

Resource links provided by NLM:


Further study details as provided by University of Turin, Italy:

Primary Outcome Measures:
  • number of patients treated with the Decap Smart failing NIV and therefore needing endotracheal intubation [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Hospital length of stay [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • ICU length of stay [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Hospital mortality [ Time Frame: 60 days ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: May 2011
Study Completion Date: December 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DECOPD
patients with severe COPD exacerbation on NIV treated with the minimally invasive extracorporeal carbon dioxide removal device (Decap Smart)
Device: minimally invasive extracorporeal carbon dioxide removal

The application of the extracorporeal carbon dioxide removal will be initiated by using a modified continuous veno-venous hemofiltration system equipped with a membrane lung with a total membrane surface of 1,35 m2 (Decap® Smart).

Femoral vein is accessed via a double lumen catheter (14 F) inserted with the Seldinger technique and connected with the extracorporeal circuit. Blood flow is driven through the circuit by a roller nonocclusive low-flow pump (0- 450 ml/min) through a membrane lung (Euroset) that is connected to a fresh gas flow source delivering 100% oxygen at a constant rate of 8 l/min. Exiting the membrane lung, blood is driven to a hemofilter (Medica D250). The resulting plasmatic water is recirculated through the membrane lung by a peristaltic pump (0-155 ml/min).


  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • COPD
  • severe acute respiratory failure
  • after at least two hours of continuous application of non-invasive ventilatory support (NIV):
  • arterial pH ≤7.30 with an arterial pressure of CO2 (PaCO2) >20% of the baseline value and one of the following:
  • respiratory rate ≥30 breaths/min;
  • use of accessory muscles or paradoxical abdominal movements

Exclusion Criteria:

  • failure to obtain consent
  • hemodynamic instability (MAP < 60 mmHg) despite infusion of vasoactive drugs
  • contraindications to the administration of i.v. heparin (heparin induced thrombocytopenia, hemorrhage, etc.)
  • body weight >120 kg
  • contraindication to continuation of active treatment (DNR)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01422681

Locations
Italy
University of Turin, Department of Anesthesia and Intensive Care Medicine
Turin, Italy, 10126
Sponsors and Collaborators
University of Turin, Italy
Investigators
Study Director: V. Marco Ranieri, MD University of Turin
  More Information

No publications provided

Responsible Party: Marco Ranieri, MD Professor, University of Turin, Italy
ClinicalTrials.gov Identifier: NCT01422681     History of Changes
Other Study ID Numbers: DECOPD1
Study First Received: August 5, 2011
Last Updated: January 20, 2014
Health Authority: Italy: Ministry of Health

Keywords provided by University of Turin, Italy:
COPD

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 26, 2014