Acute Respiratory Distress SyndromePhase 3PARSANCT01239966
Pulmonary And Renal Support During Acute Respiratory Distress Syndrome
A Phase 3 study testing Combined ECCOR and RRT in people with Acute Respiratory Distress Syndrome and Acute Renal Failure, run by Hôpital Européen Marseille at 2 sites in France.
Trial summary
In patients presenting with the acute respiratory distress syndrome (ARDS), mechanical ventilation with low tidal volume (6 ml/kg predicted body weight) is the current gold standard for supportive care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Acute Renal Failure
- What is being tested?
- Combined ECCOR and RRT
- Type of treatment
- Medical device
- How many people
- 11 participants
- Where
- 2 sitesFrance
- Study dates
- Nov 2010to Jun 2015
- Phase
- Phase 3
- 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 Respiratory Distress Syndrome according to the AECC definition
- Acute Renal Failure according to the RIFLE definition
Who cannot join
- Age < 18 years
- PaO2/FiO2 < 100 with FIO2 = 1 and PEEP > 18 cmH2O
- DNR order or death expected within the next 3 days
- Intracranial haemorrhage or hypertension
- Heparin allergy
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hopital Paul Desbief
Marseille, 13002
Hopital Ambroise Pare
Marseille, 13006
About this study
Official title: Safety and Efficacy of Combined Extracorporeal CO2 Removal and Renal Replacement Therapy in Patients With the Acute Respiratory Distress Syndrome and Acute Renal Failure
In patients presenting with the acute respiratory distress syndrome (ARDS), mechanical ventilation with low tidal volume (6 ml/kg predicted body weight) is the current gold standard for supportive care. However, despite a relative low tidal volume, approximatively one third of patients will experienced tidal hyperinflation, a phenomenon known to induce pulmonary and systemic inflammatory response. A further reduction of the tidal volume to 4 ml/kg (PBW) will prevent pulmonary area from tidal hyperinflation. As a result, hypercarbia and respiratory acidosis are commonly observed with such very low tidal ventilation. Extra corporeal CO2 removal is one of a mean to normalize arterial CO2 tension.
Patients with ARDS also frequently develop acute renal failure which may required Renal Replacement Therapy. Some data suggests that starting early the RRT may favor outcome.
Read more
The investigators hypothesized that a strategy combining ECCOR and RRT early in the course of patients presenting ARDS and acute renal failure will allow the tidal volume to be further reduced, providing lung protection, while avoiding the arterial CO2 tension to be increased.
For this purpose, the investigators sought to evaluate the safety and efficacy of adding a membranel oxygenator within an hemofiltration circuit, either upstream or downstream of the hemofilter.
- Being tested
- Combined ECCOR and RRT
- Keywords
- Acute Respiratory Distress syndrome, Acute renal Failure
- Medical subject headings
- Respiratory Distress Syndrome, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined ECCOR and RRTDevice
Insertion of a membrane oxygenator (Hilite 2400 LT, Medos, Germany) within an hemofilter circuit (M150,PrismaFlex, Hospal); either upstream or downstream of the hemofilter.
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial carbon dioxide reduction
20 % reduction of arterial carbon dioxide tension after 20 min of combined ECCOR and RRT
Measured: 20 min
Secondary outcomes (5)
Gas transfer measurement
Measurement of PO2 and PCO2 before and after the membrane oxygenation
Measured: 20 min, H1, H6, H12, H24, H36, H48 and H72.
Arterial blood gases
Measurement of arterial blood gases
Measured: 20 min, H1, H6, H12, H24, H36, H48 and H72.
carbon dioxide elimination (VCO2)
Measurement of carbon dioxide elimination rate at the ventilator and at the membrane oxygenator
Measured: 20 min, H1, H6, H12, H24, H36, H48 and H72.
Respiratory mechanics and hemodynamic parameters
Measurement of respiratory mechanics and hemodynamic parameters
Measured: 20 min, H1, H6, H12, H24, H36, H48 and H72.
Safety monitoring
Continuous measurement of the differential pressure across the oxygenator membrane and across the hemofilter.
Assessment of catheter dysfunction, clotting or disruption of the extra-corporeal circuit, clotting of the oxygenator membrane or of the hemofilter.
Assessment of patient's haemorragic or thrombotic complications.
Measured: 20 min, H1, H6, H12, H24, H36, H48 and H72.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionDec 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Européen Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jerome Allardet-Servent, MD, Hôpital Européen Marseille
- Investigators
- Jérôme Allardet-Servent, MD, Principal investigator, Hopital Ambroise Pare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01239966
- Sponsor's protocol ID
- 2010-A00397-32
- Acronym
- PARSA
- Status last verified
- Feb 2016
- First submitted
- 12 Nov 2010
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Terragni PP, Rosboch G, Tealdi A, Corno E, Menaldo E, Davini O, Gandini G, Herrmann P, Mascia L, Quintel M, Slutsky AS, Gattinoni L, Ranieri VM. Tidal hyperinflation during low tidal volume ventilation in acute respiratory distress syndrome. Am J Respir Crit Care Med. 2007 Jan 15;175(2):160-6. doi: 10.1164/rccm.200607-915OC. Epub 2006 Oct 12.
PubMed 17038660Terragni PP, Del Sorbo L, Mascia L, Urbino R, Martin EL, Birocco A, Faggiano C, Quintel M, Gattinoni L, Ranieri VM. Tidal volume lower than 6 ml/kg enhances lung protection: role of extracorporeal carbon dioxide removal. Anesthesiology. 2009 Oct;111(4):826-35. doi: 10.1097/ALN.0b013e3181b764d2.
PubMed 19741487
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Combined Extracorporeal CO2 Removal and Renal Replacement Therapy in Patients With the Acute Respiratory Distress Syndrome and Acute Renal Failure
- ClinicalTrials.gov ID
- NCT01239966
- Acronym / sponsor ID
- PARSA / 2010-A00397-32
- Keywords
- Acute Respiratory Distress syndrome, Acute renal Failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Hôpital Européen MarseilleUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 15 Nov 2010 (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.
In patients presenting with the acute respiratory distress syndrome (ARDS), mechanical ventilation with low tidal volume (6 ml/kg predicted body weight) is the current gold standard for supportive care. However, despite a relative low tidal volume, approximatively one third of patients will experienced tidal hyperinflation, a phenomenon known to induce pulmonary and systemic inflammatory response. A further reduction of the tidal volume to 4 ml/kg (PBW) will prevent pulmonary area from tidal hyperinflation. As a result, hypercarbia and respiratory acidosis are commonly observed with such very low tidal ventilation. Extra corporeal CO2 removal is one of a mean to normalize arterial CO2 tension.
Patients with ARDS also frequently develop acute renal failure which may required Renal Replacement Therapy. Some data suggests that starting early the RRT may favor outcome.
The investigators hypothesized that a strategy combining ECCOR and RRT early in the course of patients presenting ARDS and acute renal failure will allow the tidal volume to be further reduced, providing lung protection, while avoiding the arterial CO2 tension to be increased.
For this purpose, the investigators sought to evaluate the safety and efficacy of adding a membranel oxygenator within an hemofiltration circuit, either upstream or downstream of the hemofilter.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acute Respiratory Distress Syndrome according to the AECC definition
- Acute Renal Failure according to the RIFLE definition
Key exclusion criteria (5 listed)
- Age < 18 years
- PaO2/FiO2 < 100 with FIO2 = 1 and PEEP > 18 cmH2O
- DNR order or death expected within the next 3 days
- Intracranial haemorrhage or hypertension
- Heparin allergy
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 |
|---|---|---|
| Combined ECCOR and RRTInsertion of a membrane oxygenator (Hilite 2400 LT, Medos, Germany) within an hemofilter circuit (M150,PrismaFlex, Hospal); either upstream or downstream of the hemofilter. | Device | – |
Primary outcome
Arterial carbon dioxide reduction
Time frame: 20 min
20 % reduction of arterial carbon dioxide tension after 20 min of combined ECCOR and RRT
5 secondary outcomes
Gas transfer measurement
Time frame: 20 min, H1, H6, H12, H24, H36, H48 and H72.
Arterial blood gases
Time frame: 20 min, H1, H6, H12, H24, H36, H48 and H72.
carbon dioxide elimination (VCO2)
Time frame: 20 min, H1, H6, H12, H24, H36, H48 and H72.
Respiratory mechanics and hemodynamic parameters
Time frame: 20 min, H1, H6, H12, H24, H36, H48 and H72.
Safety monitoring
Time frame: 20 min, H1, H6, H12, H24, H36, H48 and H72.
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 23 Feb 2016.
- Background: PubMed 17038660Terragni PP, Rosboch G, Tealdi A, Corno E, Menaldo E, Davini O, Gandini G, Herrmann P, Mascia L, Quintel M, Slutsky AS, Gattinoni L, Ranieri VM. Tidal hyperinflation during low tidal volume ventilation in acute respiratory distress syndrome. Am J Respir Crit Care Med. 2007 Jan 15;175(2):160-6. doi: 10.1164/rccm.200607-915OC. Epub 2006 Oct 12.
- Results publication: PubMed 19741487Terragni PP, Del Sorbo L, Mascia L, Urbino R, Martin EL, Birocco A, Faggiano C, Quintel M, Gattinoni L, Ranieri VM. Tidal volume lower than 6 ml/kg enhances lung protection: role of extracorporeal carbon dioxide removal. Anesthesiology. 2009 Oct;111(4):826-35. doi: 10.1097/ALN.0b013e3181b764d2.
- information related to hospitals and investigators involvedLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Jérôme Allardet-Servent, MD principal investigator
Hopital Ambroise Pare
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Combined ECCOR and RRT in people with Acute Respiratory Distress Syndrome and Acute Renal Failure, run by Hôpital Européen Marseille at 2 sites in France.
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 2 inclusion and 5 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 23 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Arterial carbon dioxide reduction (time frame: 20 min). 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 NCT01239966, which also lists 2 linked publications.
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 23 Feb 2016.