Back to resultsVenovenous CO2 Removal (VVCO2R) in Patients With COPD and Acute Respiratory Failure (VVCO2R)
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Venovenous CO2 Removal (VVCO2R) in COPD
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive
Eligibility Criteria
Inclusion Criteria:
- Acute respiratory failure on invasive mechanical ventilation or
- Acute respiratory failure and an advanced directive foregoing invasive mechanical ventilation
- Established diagnosis of COPD
- Age group: 18 years or greater
Exclusion Criteria:
- Significant vasopressor support
- Systolic BP < 100 torr systolic despite vasopressor support
- Class III or Class IV congestive heart failure
- Left ventricular ejection fraction < 30% by previous echocardiogram
- Recent (6 month) history of myocardial infarction
- Coronary artery disease with unstable angina
- Recent (6 month) history of venous embolism
- Uncontrolled coagulopathy (international normalized ratio (INR) > 5 or activated partial thromboplastin time (aPTT) > 80s) despite corrective therapy
- History of heparin-induced thrombocytopenia or other adverse event following the administration of heparin (heparin group only)
- Pregnancy
- Severe chronic liver disease
- Severe anemia (Hgb < 9 gm/dl)
- Any contraindication to systemic anticoagulation with heparin, including recent central nervous system injury or hemorrhage, retinal hemorrhage or other recent hemorrhage from sites which cannot be controlled
- Technically unable to access vessels (obesity, limb deformity, previous surgery at the site, infection, etc.)
- Evidence of increased intracranial pressure or history of an intracranial hemorrhage within the past 3 months
Sites / Locations
- University of Texas Medical Branch
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Venovenous CO2 Removal (VVCO2R) in COPD
Arm Description
All patients enrolled in the trial will receive VVCO2R which consists of a circuit with a centrifugal pump, tubing, double lumen intravenous catheter and hollow fiber oxygenator
Outcomes
Primary Outcome Measures
The Amount of CO2 Transferred Through the Oxygenator at Various Levels of Blood and Gas Flow
The amount of CO2 removed in cc/min will be recorded. The level of blood flow (ml/min) and gas flow (l/min) at each measurement of CO2 removal will also be recorded
Secondary Outcome Measures
Full Information
NCT ID
NCT00594009
First Posted
December 17, 2007
Last Updated
February 15, 2019
Sponsor
The University of Texas Medical Branch, Galveston
1. Study Identification
Unique Protocol Identification Number
NCT00594009
Brief Title
Venovenous CO2 Removal (VVCO2R) in Patients With COPD and Acute Respiratory Failure
Acronym
VVCO2R
Official Title
Safety and Efficacy of Venovenous Carbon Dioxide Removal in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Acute Respiratory Failure (ARF)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Why Stopped
due to loss of key personnel due to illness and sabbatical of thePI
Study Start Date
January 2008 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study to determine the safety and effectiveness of a mechanical device to remove carbon dioxide from the blood of patients with chronic obstructive pulmonary disease (COPD)when they are hospitalized in the intensive care unit for exacerbation of their condition.
Detailed Description
This is a pilot study to examine the efficacy and safety of an extracorporeal circuit to remove carbon dioxide (CO2) from the blood in patients with an acute exacerbation of COPD resulting in acute or acute on chronic respiratory failure. The extracorporeal circuit consists of venovenous configuration through a percutaneously inserted 18 F double lumen catheter placed in a central vein. Centrifugal pump and heparin bonded circuit are used and patient is heparinized to maintain an activated clotting time (ACT) > 180. Circuit blood flow and gas sweep speed will be adjusted to maximize CO2 removal and minimize ventilator settings and patient's work of breathing. Patients will remain on the extracorporeal circuit for a maximum of four days as tolerated. Plasma Hemoglobin will be monitored daily.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Venovenous CO2 Removal (VVCO2R) in COPD
Arm Type
Experimental
Arm Description
All patients enrolled in the trial will receive VVCO2R which consists of a circuit with a centrifugal pump, tubing, double lumen intravenous catheter and hollow fiber oxygenator
Intervention Type
Device
Intervention Name(s)
Venovenous CO2 Removal (VVCO2R) in COPD
Other Intervention Name(s)
(VVCO2R)
Intervention Description
Patients who meet criteria will be placed on an extracorporeal circuit consisting of an oxygenator, centrifugal pump, tubing and indwelling double lumen venous catheter for CO2 removal for up to 96 hours for treatment of COPD exacerbation requiring hospitalization and intensive care
Primary Outcome Measure Information:
Title
The Amount of CO2 Transferred Through the Oxygenator at Various Levels of Blood and Gas Flow
Description
The amount of CO2 removed in cc/min will be recorded. The level of blood flow (ml/min) and gas flow (l/min) at each measurement of CO2 removal will also be recorded
Time Frame
0 to 96 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Acute respiratory failure on invasive mechanical ventilation or
Acute respiratory failure and an advanced directive foregoing invasive mechanical ventilation
Established diagnosis of COPD
Age group: 18 years or greater
Exclusion Criteria:
Significant vasopressor support
Systolic BP < 100 torr systolic despite vasopressor support
Class III or Class IV congestive heart failure
Left ventricular ejection fraction < 30% by previous echocardiogram
Recent (6 month) history of myocardial infarction
Coronary artery disease with unstable angina
Recent (6 month) history of venous embolism
Uncontrolled coagulopathy (international normalized ratio (INR) > 5 or activated partial thromboplastin time (aPTT) > 80s) despite corrective therapy
History of heparin-induced thrombocytopenia or other adverse event following the administration of heparin (heparin group only)
Pregnancy
Severe chronic liver disease
Severe anemia (Hgb < 9 gm/dl)
Any contraindication to systemic anticoagulation with heparin, including recent central nervous system injury or hemorrhage, retinal hemorrhage or other recent hemorrhage from sites which cannot be controlled
Technically unable to access vessels (obesity, limb deformity, previous surgery at the site, infection, etc.)
Evidence of increased intracranial pressure or history of an intracranial hemorrhage within the past 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victor J Cardenas, Jr, MD
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Venovenous CO2 Removal (VVCO2R) in Patients With COPD and Acute Respiratory Failure
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