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

Primary Purpose

ACUTE RESPIRATORY DISTRESS SYNDROME

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
extracorporeal removal of CO2 (ECCO2-R)
No extracorporeal CO2-removal
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ACUTE RESPIRATORY DISTRESS SYNDROME

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ghent University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

extracorporeal CO2

Arm Description

Outcomes

Primary Outcome Measures

To obtain a reduction of 20% in arterial partial CO2 pressure (PaCO2) after the first two hours of ECCO2-R therapy.
Arterial blood gasses, ventilator settings will be measured.

Secondary Outcome Measures

Reduction in Plateau pressures to levels between 25 and 28 cm H2O.
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.
Arterial blood gasses and ventilator settings will be measured.
Increase in pH to the normal range of 7,35 to 7,45.
Arterial blood gasses and ventilator settings will be measured.

Full Information

First Posted
July 23, 2013
Last Updated
December 12, 2022
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT01911533
Brief Title
Veno-venous Extracorporeal CO2 Removal in ARDS-patients to Treat Respiratory Acidosis
Official Title
Veno-venous Extracorporeal CO2 Removal in ARDS-patients to Treat Respiratory Acidosis.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
February 20, 2014 (Actual)
Primary Completion Date
June 12, 2014 (Actual)
Study Completion Date
September 12, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACUTE RESPIRATORY DISTRESS SYNDROME

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
extracorporeal CO2
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
extracorporeal removal of CO2 (ECCO2-R)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
No extracorporeal CO2-removal
Intervention Description
Patients are their own control group.
Primary Outcome Measure Information:
Title
To obtain a reduction of 20% in arterial partial CO2 pressure (PaCO2) after the first two hours of ECCO2-R therapy.
Description
Arterial blood gasses, ventilator settings will be measured.
Time Frame
After the first two hours of ECCO2-R therapy, every 2 hours for a maximum of 5 days.
Secondary Outcome Measure Information:
Title
Reduction in Plateau pressures to levels between 25 and 28 cm H2O.
Description
Arterial blood gasses and ventilator settings will be measured.
Time Frame
Every 2 hours during procedure for a maximum of 5 days.
Title
• Reduction in tidal volumes to 6ml/kg predicted body weight (PBW) or lower, with a minimum of 3ml/kg PBW.
Description
Arterial blood gasses and ventilator settings will be measured.
Time Frame
Every 2 hours during the procedure for a maximum of 5 days.
Title
Increase in pH to the normal range of 7,35 to 7,45.
Description
Arterial blood gasses and ventilator settings will be measured.
Time Frame
Every 2 hours during the procedure for a maximum of 5 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harlinde Peperstraete, MD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ghent University Hospital
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
29179681
Citation
Peperstraete H, Eloot S, Depuydt P, De Somer F, Roosens C, Hoste E. Low flow extracorporeal CO2 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.
Results Reference
derived
Links:
URL
http://www.uzgent.be
Description
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Veno-venous Extracorporeal CO2 Removal in ARDS-patients to Treat Respiratory Acidosis

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