Clinical trial NCT00594009: Venovenous CO2 Removal (VVCO2R) in Patients With COPD and Acute Respiratory Failure
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
Overall status: TERMINATED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2008-01-15
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The Amount of CO2 Transferred Through the Oxygenator at Various Levels of Blood and Gas Flow
timeFrame: 0 to 96 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: University of Texas
name: Victor J Cardenas, Jr, MD
role: PRINCIPAL_INVESTIGATOR
References: