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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)
Sponsor:
Information provided by (Responsible Party):
The University of Texas, Galveston
ClinicalTrials.gov Identifier:
NCT00594009
First received: December 17, 2007
Last updated: February 11, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention Phase
Pulmonary Disease, Chronic Obstructive
 Device: Rotaflow centrifugal pump (Maquet, Inc.)
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Venovenous Carbon Dioxide Removal in Patients With Chronic Obstructive Pulmonary Disease and Acute Respiratory Failure

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of Texas, Galveston:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 2
Study Start Date: January 2008
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
All patients enrolled in the trial will receive the proposed intervention
 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 (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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00594009

Locations
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555
Sponsors and Collaborators
The University of Texas, Galveston
Investigators
Principal Investigator: Victor J Cardenas, Jr, MD University of Texas
  More Information

No publications provided

Responsible Party: The University of Texas, Galveston
ClinicalTrials.gov Identifier: NCT00594009     History of Changes
Other Study ID Numbers: 03-142
Study First Received: December 17, 2007
Last Updated: February 11, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Respiratory Distress Syndrome, Adult
 Respiratory Insufficiency
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013