Pulmonary Disease, Chronic ObstructiveVVCO2RNCT00594009
Venovenous CO2 Removal (VVCO2R) in Patients With COPD and Acute Respiratory Failure
A study testing Venovenous CO2 Removal (VVCO2R) in COPD in people with Pulmonary Disease, Chronic Obstructive, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Venovenous CO2 Removal (VVCO2R) in COPD
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Mar 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch
Galveston, Texas, 77555
About this study
Official title: Safety and Efficacy of Venovenous Carbon Dioxide Removal in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Acute Respiratory Failure (ARF)
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.
Read the 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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Venovenous CO2 Removal (VVCO2R) in COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venovenous CO2 Removal (VVCO2R) in COPDDevice
Also called (VVCO2R)
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Venovenous CO2 Removal (VVCO2R) in COPD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0 to 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionMar 2011
- Study completionMar 2011
Why it stopped: due to loss of key personnel due to illness and sabbatical of thePI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Victor J Cardenas, Jr, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00594009
- Sponsor's protocol ID
- 03-142
- Acronym
- VVCO2R
- Status last verified
- Sep 2015
- First submitted
- 17 Dec 2007
- Last updated
- 12 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Venovenous Carbon Dioxide Removal in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Acute Respiratory Failure (ARF)
- ClinicalTrials.gov ID
- NCT00594009
- Acronym / sponsor ID
- VVCO2R / 03-142
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to loss of key personnel due to illness and sabbatical of thePI
- Enrolment
- 1 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 15 Jan 2008 (estimated)
- Results
- Posted 12 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Venovenous CO2 Removal (VVCO2R) in COPD | Experimental | Device: Venovenous CO2 Removal (VVCO2R) in COPDAll 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venovenous CO2 Removal (VVCO2R) in COPDAlso: (VVCO2R)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 | Device | Venovenous CO2 Removal (VVCO2R) in COPD |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victor J Cardenas, Jr, MD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Venovenous CO2 Removal (VVCO2R) in COPD in people with Pulmonary Disease, Chronic Obstructive, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Amount of CO2 Transferred Through the Oxygenator at Various Levels of Blood and Gas Flow (time frame: 0 to 96 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2019.