ACUTE RESPIRATORY DISTRESS SYNDROMENCT01911533
Veno-venous Extracorporeal CO2 Removal in ARDS-patients to Treat Respiratory Acidosis
A study testing extracorporeal removal of CO2 (ECCO2-R) and No extracorporeal CO2-removal in people with ACUTE RESPIRATORY DISTRESS SYNDROME, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ACUTE RESPIRATORY DISTRESS SYNDROME
- What is being tested?
- extracorporeal removal of CO2 (ECCO2-R) and No extracorporeal CO2-removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Feb 2014to 12 Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- <18 years of age
- Pregnancy
- Obesity with BMI> 30
- Contraindication for anticlotting therapy
- Chest wall abnormalities
- No presumed consent of representatives
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- extracorporeal removal of CO2 (ECCO2-R), No extracorporeal CO2-removal
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extracorporeal removal of CO2 (ECCO2-R)Procedure or surgery
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-removalProcedure or surgery
Patients are their own control group.
| Study group | Role | What they receive |
|---|---|---|
| extracorporeal CO2 | Experimental | Not described Receives: Procedure: extracorporeal removal of CO2 (ECCO2-R); Procedure: No extracorporeal CO2-removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Arterial blood gasses and ventilator settings will be measured.
Measured: 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.
Arterial blood gasses and ventilator settings will be measured.
Measured: 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.
Arterial blood gasses and ventilator settings will be measured.
Measured: Every 2 hours during the procedure for a maximum of 5 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study start20 Feb 2014
- Primary completion12 Jun 2014
- Study completion12 Sep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ACUTE RESPIRATORY DISTRESS SYNDROMEStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harlinde Peperstraete, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01911533
- Sponsor's protocol ID
- 2013/505
- Status last verified
- Dec 2022
- First submitted
- 23 Jul 2013
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29179681
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Veno-venous Extracorporeal CO2 Removal in ARDS-patients to Treat Respiratory Acidosis.
- ClinicalTrials.gov ID
- NCT01911533
- Acronym / sponsor ID
- 2013/505
- Conditions
- ACUTE RESPIRATORY DISTRESS SYNDROME
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 20 Feb 2014 (actual)
- Primary completion
- 12 Jun 2014 (actual)
- Study completion
- 12 Sep 2014 (actual)
- First posted
- 30 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| extracorporeal CO2 | Experimental | Procedure: extracorporeal removal of CO2 (ECCO2-R), Procedure: No extracorporeal CO2-removal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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,
Key exclusion criteria (6 listed)
- <18 years of age
- Pregnancy
- Obesity with BMI> 30
- Contraindication for anticlotting therapy
- Chest wall abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | extracorporeal CO2 |
| No extracorporeal CO2-removalPatients are their own control group. | Procedure or surgery | extracorporeal CO2 |
Primary outcome
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.
3 secondary outcomes
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.
• 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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
- Derived from this study: PubMed 29179681Peperstraete 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harlinde Peperstraete, MD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing extracorporeal removal of CO2 (ECCO2-R) and No extracorporeal CO2-removal in people with ACUTE RESPIRATORY DISTRESS SYNDROME, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01911533, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2022.