Venovenous CO2 Removal (VVCO2R) in Patients With COPD and Acute Respiratory Failure



Status:Terminated
Conditions:Chronic Obstructive Pulmonary Disease, Hospital, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases, Other
Healthy:No
Age Range:18 - Any
Updated:3/14/2019
Start Date:January 2008
End Date:March 2011

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Safety and Efficacy of Venovenous Carbon Dioxide Removal in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Acute Respiratory Failure (ARF)

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.

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.

Inclusion Criteria:

1. Acute respiratory failure on invasive mechanical ventilation or

2. Acute respiratory failure and an advanced directive foregoing invasive mechanical
ventilation

3. Established diagnosis of COPD

4. Age group: 18 years or greater

Exclusion Criteria:

1. Significant vasopressor support

2. Systolic BP < 100 torr systolic despite vasopressor support

3. Class III or Class IV congestive heart failure

4. Left ventricular ejection fraction < 30% by previous echocardiogram

5. Recent (6 month) history of myocardial infarction

6. Coronary artery disease with unstable angina

7. Recent (6 month) history of venous embolism

8. Uncontrolled coagulopathy (international normalized ratio (INR) > 5 or activated
partial thromboplastin time (aPTT) > 80s) despite corrective therapy

9. History of heparin-induced thrombocytopenia or other adverse event following the
administration of heparin (heparin group only)

10. Pregnancy

11. Severe chronic liver disease

12. Severe anemia (Hgb < 9 gm/dl)

13. 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

14. Technically unable to access vessels (obesity, limb deformity, previous surgery at the
site, infection, etc.)

15. Evidence of increased intracranial pressure or history of an intracranial hemorrhage
within the past 3 months
We found this trial at
1
site
301 University Blvd
Galveston, Texas 77555
(409) 772-1011
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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mi
from
Galveston, TX
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