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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: June 5, 2014
Last verified: June 2014

December 17, 2007
June 5, 2014
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 ClinicalTrials.gov 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.

Not Provided
Interventional
Phase 1
Phase 2
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00594009
03-142
No
The University of Texas, Galveston
The University of Texas, Galveston
Not Provided
Principal Investigator: Victor J Cardenas, Jr, MD University of Texas
The University of Texas, Galveston
June 2014

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