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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00594009
Recruitment Status : Terminated (due to loss of key personnel due to illness and sabbatical of thePI)
First Posted : January 15, 2008
Results First Posted : March 12, 2019
Last Update Posted : March 12, 2019
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

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.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Device: Venovenous CO2 Removal (VVCO2R) in COPD Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Venovenous Carbon Dioxide Removal in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Acute Respiratory Failure (ARF)
Study Start Date : January 2008
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

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 Name: (VVCO2R)

Primary Outcome Measures :
  1. The Amount of CO2 Transferred Through the Oxygenator at Various Levels of Blood and Gas Flow [ Time Frame: 0 to 96 hours ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00594009

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United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
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Principal Investigator: Victor J Cardenas, Jr, MD University of Texas
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Responsible Party: The University of Texas Medical Branch, Galveston Identifier: NCT00594009    
Other Study ID Numbers: 03-142
First Posted: January 15, 2008    Key Record Dates
Results First Posted: March 12, 2019
Last Update Posted: March 12, 2019
Last Verified: September 2015
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Insufficiency
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Respiration Disorders
Lung Diseases, Obstructive