NCT01911533

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

Completed NA Last updated 15 December 2022

What this trial tests

NA trial testing extracorporeal removal of CO2 (ECCO2-R) in ACUTE RESPIRATORY DISTRESS SYNDROME in 4 participants. Completed in 12 September 2014.

Timeline

20 February 2014

Primary endpoint
12 June 2014

12 September 2014

Quick facts

Lead sponsor	University Hospital, Ghent
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	4
Start date	20 February 2014
Primary completion	12 June 2014
Estimated completion	12 September 2014
Sites	1 location across Belgium

Drugs / interventions tested

• extracorporeal removal of CO2 (ECCO2-R)
• No extracorporeal CO2-removal

Conditions studied

• ACUTE RESPIRATORY DISTRESS SYNDROME — all drugs for ACUTE RESPIRATORY DISTRESS SYNDROME →

Sponsor

University Hospital, Ghent

Who can join

18 and older, any sex, with ACUTE RESPIRATORY DISTRESS SYNDROME. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Low flow extracorporeal CO₂ removal in ARDS patients: a prospective short-term crossover pilot study.
   Peperstraete H, Eloot S, Depuydt P, De Somer F, et al · · 2017 · cited 17× · PMID 29179681 · DOI 10.1186/s12871-017-0445-9