Extracorporeal CO2 Removal in COPD Exacerbation (DECOPD)
Primary Purpose
COPD Exacerbation
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
minimally invasive extracorporeal carbon dioxide removal
Sponsored by
About this trial
This is an interventional supportive care trial for COPD Exacerbation focused on measuring COPD
Eligibility 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)
Sites / Locations
- University of Turin, Department of Anesthesia and Intensive Care Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DECOPD
Arm Description
patients with severe COPD exacerbation on NIV treated with the minimally invasive extracorporeal carbon dioxide removal device (Decap Smart)
Outcomes
Primary Outcome Measures
number of patients treated with the Decap Smart failing NIV and therefore needing endotracheal intubation
Secondary Outcome Measures
Adverse events
Hospital length of stay
ICU length of stay
Hospital mortality
Full Information
NCT ID
NCT01422681
First Posted
August 5, 2011
Last Updated
January 20, 2014
Sponsor
University of Turin, Italy
1. Study Identification
Unique Protocol Identification Number
NCT01422681
Brief Title
Extracorporeal CO2 Removal in COPD Exacerbation
Acronym
DECOPD
Official Title
Extracorporeal Carbon Dioxide Removal in Patients With Severe COPD Exacerbation Failing Noninvasive Ventilation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Turin, Italy
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD Exacerbation
Keywords
COPD
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DECOPD
Arm Type
Experimental
Arm Description
patients with severe COPD exacerbation on NIV treated with the minimally invasive extracorporeal carbon dioxide removal device (Decap Smart)
Intervention Type
Device
Intervention Name(s)
minimally invasive extracorporeal carbon dioxide removal
Intervention Description
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).
Primary Outcome Measure Information:
Title
number of patients treated with the Decap Smart failing NIV and therefore needing endotracheal intubation
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Adverse events
Time Frame
1 month
Title
Hospital length of stay
Time Frame
18 months
Title
ICU length of stay
Time Frame
18 months
Title
Hospital mortality
Time Frame
60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
V. Marco Ranieri, MD
Organizational Affiliation
University of Turin, Italy
Official's Role
Study Director
Facility Information:
Facility Name
University of Turin, Department of Anesthesia and Intensive Care Medicine
City
Turin
ZIP/Postal Code
10126
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
25230375
Citation
Del Sorbo L, Pisani L, Filippini C, Fanelli V, Fasano L, Terragni P, Dell'Amore A, Urbino R, Mascia L, Evangelista A, Antro C, D'Amato R, Sucre MJ, Simonetti U, Persico P, Nava S, Ranieri VM. Extracorporeal Co2 removal in hypercapnic patients at risk of noninvasive ventilation failure: a matched cohort study with historical control. Crit Care Med. 2015 Jan;43(1):120-7. doi: 10.1097/CCM.0000000000000607.
Results Reference
derived
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Extracorporeal CO2 Removal in COPD Exacerbation
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