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

NCT00594009 | Terminated Results

• 1 other identifier: 03-142
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• The Amount of CO2 Transferred Through the Oxygenator at Various Levels of Blood and Gas Flow

  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

  0 to 96 hours

Study Arms (1)

Venovenous CO2 Removal (VVCO2R) in COPD

EXPERIMENTAL

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

Interventions

Venovenous CO2 Removal (VVCO2R) in COPD DEVICE

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

Also known as: (VVCO2R)

Venovenous CO2 Removal (VVCO2R) in COPD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute respiratory failure on invasive mechanical ventilation or
• Acute respiratory failure and an advanced directive foregoing invasive mechanical ventilation
• Established diagnosis of COPD
• Age group: 18 years or greater

You may not qualify if:

• Significant vasopressor support
• Systolic BP \< 100 torr systolic despite vasopressor support
• Class III or Class IV congestive heart failure
• Left ventricular ejection fraction \< 30% by previous echocardiogram
• Recent (6 month) history of myocardial infarction
• Coronary artery disease with unstable angina
• Recent (6 month) history of venous embolism
• Uncontrolled coagulopathy (international normalized ratio (INR) \> 5 or activated partial thromboplastin time (aPTT) \> 80s) despite corrective therapy
• History of heparin-induced thrombocytopenia or other adverse event following the administration of heparin (heparin group only)
• Pregnancy
• Severe chronic liver disease
• Severe anemia (Hgb \< 9 gm/dl)
• 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
• Technically unable to access vessels (obesity, limb deformity, previous surgery at the site, infection, etc.)
• Evidence of increased intracranial pressure or history of an intracranial hemorrhage within the past 3 months

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Victor Cardenas, MD
• Organization: University of Texas Medical Branch

vcardena@utmb.edu

(409) 772-2436

Study Officials

• Victor J Cardenas, Jr, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2007
• First Posted: January 15, 2008
• Study Start: January 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: March 12, 2019
• Results First Posted: March 12, 2019

Record last verified: 2015-09

Locations

US (1)