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

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.

Study Overview

• Status: Terminated
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Device: Venovenous CO2 Removal (VVCO2R) in COPD

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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; Other Names: (VVCO2R)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Investigators: Principal Investigator: Victor J Cardenas, Jr, MD, University of Texas

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: December 17, 2007
• First Submitted That Met QC Criteria: January 2, 2008
• First Posted (Estimate): January 15, 2008

Study Record Updates

• Last Update Posted (Actual): March 12, 2019
• Last Update Submitted That Met QC Criteria: February 15, 2019
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency
• Other Study ID Numbers: 03-142