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

NCT01911533 | Completed

• 1 other identifier: 2013/505
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

ACUTE RESPIRATORY DISTRESS SYNDROME

Outcome Measures

Primary Outcomes (1)

• 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.

  After the first two hours of ECCO2-R therapy, every 2 hours for a maximum of 5 days.

Secondary Outcomes (3)

• Reduction in Plateau pressures to levels between 25 and 28 cm H2O.

  Every 2 hours during procedure for a maximum of 5 days.

• • Reduction in tidal volumes to 6ml/kg predicted body weight (PBW) or lower, with a minimum of 3ml/kg PBW.

  Every 2 hours during the procedure for a maximum of 5 days.

• Increase in pH to the normal range of 7,35 to 7,45.

  Every 2 hours during the procedure for a maximum of 5 days.

Study Arms (1)

extracorporeal CO2

EXPERIMENTAL

Procedure: extracorporeal removal of CO2 (ECCO2-R); Procedure: No extracorporeal CO2-removal

Interventions

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.

extracorporeal CO2

No extracorporeal CO2-removal PROCEDURE

Patients are their own control group.

extracorporeal CO2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• \<18 years of age
• Pregnancy
• Obesity with BMI\> 30
• Contraindication for anticlotting therapy
• Chest wall abnormalities
• No presumed consent of representatives

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

Related Publications (1)

• 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.

  PMID: 29179681 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Harlinde Peperstraete, MD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2013
• First Posted: July 30, 2013
• Study Start: February 20, 2014
• Primary Completion: June 12, 2014
• Study Completion: September 12, 2014
• Last Updated: December 15, 2022

Record last verified: 2022-12

Locations

BE (1)