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Veno-venous Extracorporeal CO2 Removal in ARDS-patients to Treat Respiratory Acidosis

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ClinicalTrials.gov Identifier: NCT01911533
Recruitment Status : Unknown
Verified June 2015 by University Hospital, Ghent.
Recruitment status was:  Recruiting
First Posted : July 30, 2013
Last Update Posted : June 3, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
ACUTE RESPIRATORY DISTRESS SYNDROME Procedure: extracorporeal removal of CO2 (ECCO2-R) Procedure: No extracorporeal CO2-removal Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Veno-venous Extracorporeal CO2 Removal in ARDS-patients to Treat Respiratory Acidosis.
Study Start Date : August 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015


Arm Intervention/treatment
Experimental: extracorporeal CO2 Procedure: extracorporeal removal of CO2 (ECCO2-R)
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.

Procedure: No extracorporeal CO2-removal
Patients are their own control group.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. ]
    Arterial blood gasses and ventilator settings will be measured.

  2. • 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. ]
    Arterial blood gasses and ventilator settings will be measured.

  3. 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. ]
    Arterial blood gasses and ventilator settings will be measured.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01911533


Contacts
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Contact: Harlinde Peperstraete, MD Harlinde.Peperstraete@ugent.be

Locations
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Belgium
Ghent University Hospital Recruiting
Ghent, Belgium, 9000
Contact: Harlinde Peperstraete, MD       Harlinde.Peperstraete@ugent.be   
Principal Investigator: Harlinde Peperstraete, MD         
Principal Investigator: Eric Hoste, MD, PhD         
Sponsors and Collaborators
University Hospital, Ghent
Investigators
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Principal Investigator: Harlinde Peperstraete, MD University Hospital, Ghent

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01911533     History of Changes
Other Study ID Numbers: 2013/505
First Posted: July 30, 2013    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Acidosis
Acidosis, Respiratory
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Acid-Base Imbalance
Metabolic Diseases
Respiratory Insufficiency