Skip to main content
OpenTrials
Completed

NCT Number: NCT01911533

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University Hospital

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

extracorporeal removal of CO2 (ECCO2-R)

Procedure

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.

No extracorporeal CO2-removal

Procedure

Patients are their own control group.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jul 30, 2013
Registry last updated
Dec 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.