- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01911533
Veno-venous Extracorporeal CO2 Removal in ARDS-patients to Treat Respiratory Acidosis
Veno-venous Extracorporeal CO2 Removal in ARDS-patients to Treat Respiratory Acidosis.
Hypothesis:
Extracorporeal removal of CO2 can treat hypercapnia and respiratory acidosis, which allows application of lung protective ventilation. This downgrading of mechanical ventilation promotes better and more quickly lung recovery.
Aim:
The aim of the study is to treat respiratory acidosis and to reduce plateau pressures by using an extracorporeal removal of CO2 (ECCO2-R).
This prospective study will include 10 patients with an Acute Respiratory Distress Syndrome (ARDS). ARDS is an inflammatory response in the lungs, the onset is acute with pulmonary oedema and shows bilateral densities on chest radiography. The take up of oxygen and the loss of CO2 in the lungs are difficult. Moreover the patient's blood can become acidic due to too much CO2.
To promote a better gas-exchange, the patient with ARDS will be mechanically ventilated. This can be aggressive and harmful for the lungs. With the use of an extra-corporeal CO2-remover, CO2 can be removed so that the mechanical ventilation setting will be less aggressive and will decrease lesions in the lung. The veno-venous extracorporeal CO2-remover pumps blood from a vein via a catheter through an oxygenator (gas exchanger that adds oxygen to the blood and extracts carbon dioxide from the blood) and back into a vein.
The investigators will use a standard dialysis catheter that will be put in a large vein. To prevent clotting of the system, the patient will receive heparin.
In the study the investigators will work in periods of two hours, the situation before and after carbon dioxide removal will be compared. With this study the investigators want to prove that the CO2 in the blood decreases with at least 20 % with the use of the extracorporeal CO2 remover. More over the investigators want to prove that lower mechanical ventilation settings (thanks to CO2-removal by the ECCO2-R) will produce fewer lesions to the lungs.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Ghent, Belgium, 9000
- Ghent University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- Acute onset of ARDS criteria on chest X-ray or CT scan
- Moderate (PaO2/ FiO2 <200) or severe ARDS (PaO2/ FiO2 <100) (FiO2: fraction of inspired oxygen)
- Respiratory acidosis with pH< 7,25,
- With plateau pressure of 28cmH20 or higher,
Exclusion criteria:
- <18 years of age
- Pregnancy
- Obesity with BMI> 30
- Contraindication for anticlotting therapy
- Chest wall abnormalities
- No presumed consent of representatives
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: extracorporeal CO2
|
To promote a better gas-exchange, the patient with ARDS will be mechanically ventilated.
This can be aggressive and harmful for the lungs.
With the use of an extra-corporeal CO2-remover, CO2 can be removed so that the mechanical ventilation setting will be less aggressive and will decrease lesions in the lung.
The veno-venous extracorporeal CO2-remover pumps blood from a vein via a catheter through an oxygenator (gas exchanger that adds oxygen to the blood and extracts carbon dioxide from the blood) and back into a vein.
Patients are their own control group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To obtain a reduction of 20% in arterial partial CO2 pressure (PaCO2) after the first two hours of ECCO2-R therapy.
Time Frame: After the first two hours of ECCO2-R therapy, every 2 hours for a maximum of 5 days.
|
Arterial blood gasses, ventilator settings will be measured.
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After the first two hours of ECCO2-R therapy, every 2 hours for a maximum of 5 days.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction in Plateau pressures to levels between 25 and 28 cm H2O.
Time Frame: Every 2 hours during procedure for a maximum of 5 days.
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Arterial blood gasses and ventilator settings will be measured.
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Every 2 hours during procedure for a maximum of 5 days.
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• Reduction in tidal volumes to 6ml/kg predicted body weight (PBW) or lower, with a minimum of 3ml/kg PBW.
Time Frame: Every 2 hours during the procedure for a maximum of 5 days.
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Arterial blood gasses and ventilator settings will be measured.
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Every 2 hours during the procedure for a maximum of 5 days.
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Increase in pH to the normal range of 7,35 to 7,45.
Time Frame: Every 2 hours during the procedure for a maximum of 5 days.
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Arterial blood gasses and ventilator settings will be measured.
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Every 2 hours during the procedure for a maximum of 5 days.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Harlinde Peperstraete, MD, University Hospital, Ghent
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Lung Diseases
- Infant, Newborn, Diseases
- Lung Injury
- Respiratory Insufficiency
- Infant, Premature, Diseases
- Acid-Base Imbalance
- Respiratory Distress Syndrome
- Respiratory Distress Syndrome, Newborn
- Acute Lung Injury
- Acidosis
- Acidosis, Respiratory
Other Study ID Numbers
- 2013/505
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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