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

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

Tracking Information
First Submitted Date  ICMJE December 17, 2007
First Posted Date  ICMJE January 15, 2008
Results First Submitted Date  ICMJE August 29, 2018
Results First Posted Date  ICMJE March 12, 2019
Last Update Posted Date March 12, 2019
Study Start Date  ICMJE January 2008
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: January 2, 2008)
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 ]
Change History Complete list of historical versions of study NCT00594009 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: January 2, 2008)
  • To determine the incidence of complications including local insertion problems and distant hemorrhage [ Time Frame: 96 hours ]
  • To determine the effect of VVCO2R on platelet count and systemic cytokine levels [ Time Frame: 96 hours ]
  • To determine the effect of VVCO2R on arterial PCO2 levels, total carbon dioxide production and work of breathing [ Time Frame: 96 hours ]
  • To determine the effect on mechanical ventilation settings over time [ Time Frame: until time of extubation ]
  • To assess the effect on dyspnea and sedation requirements [ Time Frame: 96 hours ]
  • To determine the efficacy of low dose heparin in preventing clot formation [ Time Frame: 96 hour ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Venovenous CO2 Removal (VVCO2R) in Patients With COPD and Acute Respiratory Failure
Official Title  ICMJE Safety and Efficacy of Venovenous Carbon Dioxide Removal in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Acute Respiratory Failure (ARF)
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Disease, Chronic Obstructive
Intervention  ICMJE 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)
Study Arms  ICMJE 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
Intervention: Device: Venovenous CO2 Removal (VVCO2R) in COPD
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 15, 2019)
1
Original Estimated Enrollment  ICMJE
 (submitted: January 2, 2008)
8
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00594009
Other Study ID Numbers  ICMJE 03-142
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The University of Texas Medical Branch, Galveston
Study Sponsor  ICMJE The University of Texas Medical Branch, Galveston
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Victor J Cardenas, Jr, MD University of Texas
PRS Account The University of Texas Medical Branch, Galveston
Verification Date September 2015

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