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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pulmonary Disease, Chronic Obstructive
Intervention Device: Venovenous CO2 Removal (VVCO2R) in COPD
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Venovenous CO2 Removal (VVCO2R) in COPD
Hide Arm/Group Description All patients enrolled in the trial will receive the proposed 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
Period Title: Overall Study
Started 1
Completed 1
Not Completed 0
Arm/Group Title VVCO2R in COPD
Hide Arm/Group Description

All patients enrolled in the trial will receive the proposed intervention

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

Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1 participants
42 [1]   (NA)
[1]
only one subject
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
1
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
1
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
1
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
chronic obstructive pulmonary disease (COPD) patients  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
1
 100.0%
1.Primary Outcome
Title The Amount of CO2 Transferred Through the Oxygenator at Various Levels of Blood and Gas Flow
Hide Description 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
Time Frame 0 to 96 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VVCO2R in COPD
Hide Arm/Group Description:

All patients enrolled in the trial will receive the proposed intervention

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

Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: cc/min
75
Time Frame Adverse event data were collected during the study period and up to 14 days after discontinuation of device
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title VVCO2R in COPD
Hide Arm/Group Description

All patients enrolled in the trial will receive the proposed intervention

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

All-Cause Mortality
VVCO2R in COPD
Affected / at Risk (%)
Total   0/1 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
VVCO2R in COPD
Affected / at Risk (%)
Total   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
VVCO2R in COPD
Affected / at Risk (%)
Total   0/1 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Victor Cardenas, MD
Organization: University of Texas Medical Branch
Phone: (409) 772-2436
Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT00594009     History of Changes
Other Study ID Numbers: 03-142
First Submitted: December 17, 2007
First Posted: January 15, 2008
Results First Submitted: August 29, 2018
Results First Posted: March 12, 2019
Last Update Posted: March 12, 2019