Venovenous CO2 Removal in Patients With COPD and Acute Respiratory Failure (VVCCO2R)

This study has been terminated.
(due to loss of key personnel due to illness and sabbatical of thePI)
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston Identifier:
First received: December 17, 2007
Last updated: August 24, 2015
Last verified: June 2014

December 17, 2007
August 24, 2015
January 2008
March 2011   (final data collection date for primary outcome measure)
The primary parameter to judge efficacy is the amount of CO2 transferred through the oxygenator at various levels of blood and gas flow [ Time Frame: 96 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00594009 on Archive Site
  • To determine the incidence of complications including local insertion problems and distant hemorrhage [ Time Frame: 96 hours ] [ Designated as safety issue: Yes ]
  • To determine the effect of VVCO2R on platelet count and systemic cytokine levels [ Time Frame: 96 hours ] [ Designated as safety issue: Yes ]
  • To determine the effect of VVCO2R on arterial PCO2 levels, total carbon dioxide production and work of breathing [ Time Frame: 96 hours ] [ Designated as safety issue: No ]
  • To determine the effect on mechanical ventilation settings over time [ Time Frame: until time of extubation ] [ Designated as safety issue: No ]
  • To assess the effect on dyspnea and sedation requirements [ Time Frame: 96 hours ] [ Designated as safety issue: No ]
  • To determine the efficacy of low dose heparin in preventing clot formation [ Time Frame: 96 hour ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
Venovenous CO2 Removal in Patients With COPD and Acute Respiratory Failure
Safety and Efficacy of Venovenous Carbon Dioxide Removal in Patients With Chronic Obstructive Pulmonary Disease and Acute Respiratory Failure

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.

This is a pilot study to examine the efficacy and safety of an extracorporeal circuit to remove carbon dioxide 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 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.

Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pulmonary Disease, Chronic Obstructive
Device: Rotaflow centrifugal pump (Maquet, Inc.)
Patients who meet criteria will be placed on an extracorporeal device for CO2 removal for up to 96 hours for treatment of COPD exacerbation requiring hospitalization and intensive care
Experimental: 1
All patients enrolled in the trial will receive the proposed intervention
Intervention: Device: Rotaflow centrifugal pump (Maquet, Inc.)
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
March 2011
March 2011   (final data collection date for primary outcome measure)

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 (INR > 5 or 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
18 Years and older
Contact information is only displayed when the study is recruiting subjects
United States
The University of Texas Medical Branch, Galveston
The University of Texas Medical Branch, Galveston
Not Provided
Principal Investigator: Victor J Cardenas, Jr, MD University of Texas
The University of Texas Medical Branch, Galveston
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP