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

NCT ID: NCT00594009

Last Updated: 2019-03-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2011-03-31

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Venovenous CO2 Removal (VVCO2R) in COPD

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

Group Type: EXPERIMENTAL

Venovenous CO2 Removal (VVCO2R) in COPD

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

(VVCO2R)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Victor J Cardenas, Jr, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Locations

University of Texas Medical Branch

Galveston, Texas, United States

Countries

United States

Other Identifiers

03-142

Identifier Type: -

Identifier Source: org_study_id