Effect of Extracorporeal CO2 Removal in Stable Hypercapnic COPD Patients
EFFECT OF EXTRACORPOREAL CO2 REMOVAL IN STABLE COPD PATIENTS WITH CHRONIC HYPERCAPNIC RESPIRATORY FAILURE:A PILOT STUDY
1 other identifier
interventional
15
1 country
1
Brief Summary
Chronic hypercapnic respiratory failure is common in stable COPD patients in a terminal phase of their disease In an attempt to correct or slow down the rate of rise of PaCO2, long-term noninvasive mechanical ventilation (NIV) has been proposed. Only very few studies demonstrated the clinical efficacy of NIV. Indeed this technique is not always well tolerated and therefore it may be effective only in a subset of patients The aim of this study is to assess the feasibility and safety of "one shot" extrcorporeal CO2 removal device, in reducing the PaCO2 level
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 6, 2014
CompletedFirst Posted
Study publicly available on registry
October 9, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedDecember 29, 2017
December 1, 2017
4.2 years
October 6, 2014
December 27, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
arterial blood gases
30 days
Secondary Outcomes (1)
respiratory rate, dyspnea
30 days
Study Arms (1)
extracorporeal CO2 removal device
EXPERIMENTALthe patients will be enroll to start a "one shot" session of extracorporeal CO2 removal. The patient will be connected to the device via a double lumen catheter inserted in the femoral vein An ECCO2R device based on a modified continuous venovenous hemofiltration system will be used. Blood flow is driven by a roller nonocclusive pump (0-450 mL/min) through a polypropylene oxygenator ; priming volume, 100 mL; contact surface area, 1.35 m2; maximum blood flow rate, 7 L/min) that is connected to a fresh gas flow source delivering 100% oxygen at a constant rate of 8 L/min. Exiting the oxygenator, blood is driven to a hemofilter.
Interventions
An ECCO2R device based on a modified continuous venovenous hemofiltration system will be used
Eligibility Criteria
You may qualify if:
- COPD ( FEV1/CVF \<0.70 post bronchodilation)
- stable PaCO2 \>55 mmHg non respondent to long-term NIV (at least one week). This means a decrease in PaCO2 during spontaneous breathing, at least 4 hrs after the termination of NIV, of\< 6%
- pH \> 7.35
- clinical stability
You may not qualify if:
- Mean Arterial Pressure \< 60 mmHg
- contra-indication to heparin
- Body Mass Index (BMI) \> 30 kg/m2;
- presence of sleep apnea or overall syndrome
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
san'Orsola Malpighi Hospital, Bologna ITALY
Bologna, 40138, Italy
Study Officials
- PRINCIPAL INVESTIGATOR
stefano nava
sant'orsola malpighi hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PRofessor of Respiratory Medicine
Study Record Dates
First Submitted
October 6, 2014
First Posted
October 9, 2014
Study Start
October 1, 2014
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
December 29, 2017
Record last verified: 2017-12