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

Pulmonary Disease, Chronic Obstructive Clinical Trial

— VVCO2R  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00594009
• Other study ID #: 03-142
• Status: Terminated
• Phase: N/A
• Start date: January 2008
• Est. completion date: March 2011

Study information

• Verified date: September 2015
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

Device:
• Venovenous CO2 Removal (VVCO2R) in COPD
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

Locations

Country	Name	City	State
United States	University of Texas Medical Branch	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	0 to 96 hours