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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

Tracking Information
First Submitted Date  ICMJE July 23, 2013
First Posted Date  ICMJE July 30, 2013
Last Update Posted Date June 3, 2015
Study Start Date  ICMJE August 2013
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2013)
  • 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.
  • • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Veno-venous Extracorporeal CO2 Removal in ARDS-patients to Treat Respiratory Acidosis
Official Title  ICMJE Veno-venous Extracorporeal CO2 Removal in ARDS-patients to Treat Respiratory Acidosis.
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE ACUTE RESPIRATORY DISTRESS SYNDROME
Intervention  ICMJE
  • 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.
Study Arms  ICMJE Experimental: extracorporeal CO2
Interventions:
  • Procedure: extracorporeal removal of CO2 (ECCO2-R)
  • Procedure: No extracorporeal CO2-removal
Publications * Peperstraete H, Eloot S, Depuydt P, De Somer F, Roosens C, Hoste E. Low flow extracorporeal CO(2) removal in ARDS patients: a prospective short-term crossover pilot study. BMC Anesthesiol. 2017 Nov 28;17(1):155. doi: 10.1186/s12871-017-0445-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 26, 2013)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2015
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01911533
Other Study ID Numbers  ICMJE 2013/505
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Ghent
Study Sponsor  ICMJE University Hospital, Ghent
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Harlinde Peperstraete, MD University Hospital, Ghent
PRS Account University Hospital, Ghent
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP