Acute Respiratory Distress SyndromeXtraventNCT00538928
Extrapulmonary Interventional Ventilatory Support in Severe Acute Respiratory Distress Syndrome (ARDS)
A study testing lung protective ventilation in people with Acute Respiratory Distress Syndrome, run by University of Regensburg at 1 site in Germany.
Trial summary
A prospective, randomized study will be performed investigating the effects of a pumpless extracorporeal interventional lung assist [iLA] on the implementation of a lung-protective ventilatory strategy in patients with acute respiratory distress syndrome [ARDS] with a PaO2/FiO2 ratio < 200. 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?
- lung protective ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2007to Jan 2011
- 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
- The trial subjects are patients aged 18 years or older who have developed severe ARDS. Following the American-European Consensus Conference on ARDS, severe ARDS is defined as an oxygenation index (PaO2/FIO2) < 200 mmHg. These parameters must be present for a duration of at least 2 hours.
Who cannot join
- age < 18 years
- decompensated heart insufficiency
- acute coronary syndrome
- severe chronic obstructive pulmonary disease
- advanced tumour conditions with life expectancy < 6 months
- chronic dialysis treatment
Show all 12Show fewer
- lung transplant patients
- proven Heparin-induced thrombocytopenia (HIT)
- morbid obesity (BMI >) 40
- Child Class B and C cirrhosis of the liver, acute fulminant hepatic failure
- severe peripheral arterial occlusive disease (pAVK III - IV), absence of limb doppler pulse
- brain injury (GCS < 9 + CT pathology)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Extrapulmonary Interventional Ventilatory Support for Lung Protection in Severe Acute Respiratory Distress - a Prospective Randomized Multi Centre Study
A prospective, randomized study will be performed investigating the effects of a pumpless extracorporeal interventional lung assist [iLA] on the implementation of a lung-protective ventilatory strategy in patients with acute respiratory distress syndrome [ARDS] with a PaO2/FiO2 ratio < 200. The duration of ventilation, intensive care and hospital stay and in-hospital mortality will be investigated.
Read the detailed description
Evaluation group:
Implantation of the iLA - adaptation of the ventilation strategy, explantation of the iLA after corresponding improvement (see treatment plan for details) - weaning from the ventilation and extubation according to specified criteria.
Control group:
Ventilation strategy based on the concept of lung-protective ventilation without extracorporeal support, weaning from the ventilation and extubation according to specified criteria (see treatment plan for details).
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- lung protective ventilation
- Keywords
- acute respiratory distress syndrome, extracorporeal lung support, hypoxia, hypercapnia, acute respiratory distress syndrome (ARDS)
- Medical subject headings
- Respiratory Distress Syndrome, Hypoxia, Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung protective ventilationOther
tidal volume 6 ml/kg ideal body weight
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Intervention: Implantation of the iLA - adaptation of the ventilation strategy, explantation of the iLA after corresponding improvement (see treatment plan for details) - weaning from the ventilation and extubation according to specified criteria. Receives: Other: lung protective ventilation |
| 2 | Active comparator | no device: Ventilation strategy based on the concept of lung-protective ventilation without extracorporeal support, weaning from the ventilation and extubation according to specified criteria (see treatment plan for details). Receives: Other: lung protective ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator free days within 28 days after enrollment
Measured: 28 days
Secondary outcomes (1)
hospital mortality, organ-failure free days, pulmonary gas exchange
Measured: 28 days - 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionJan 2011
- Study completionJan 2011
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Regensburg
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany
- Investigators
- Thomas Bein, Professor Dr., Principal investigator, University Hospital RegensburgSteffen Weber-Carstens, Dr., Study chair, Charite University Hospital BerlinThomas Staudinger, Prof, Study chair, University Hospital Vienna, AustriaSven Bercker, MD, Study chair, University Hospital Leipzig, GermanyRalph Müllenbach, MD PhD, Study chair, University Hospital Würzburg, GermanyRolf Dembinski, MD PhD, Study chair, University Hospital Aachen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00538928
- Sponsor's protocol ID
- KKS 4012-001-07
- Acronym
- Xtravent
- Status last verified
- Mar 2009
- First submitted
- 2 Oct 2007
- Last updated
- 2 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bein T, Weber F, Philipp A, Prasser C, Pfeifer M, Schmid FX, Butz B, Birnbaum D, Taeger K, Schlitt HJ. A new pumpless extracorporeal interventional lung assist in critical hypoxemia/hypercapnia. Crit Care Med. 2006 May;34(5):1372-7. doi: 10.1097/01.CCM.0000215111.85483.BD.
PubMed 16540950Bein T, Weber-Carstens S, Goldmann A, Muller T, Staudinger T, Brederlau J, Muellenbach R, Dembinski R, Graf BM, Wewalka M, Philipp A, Wernecke KD, Lubnow M, Slutsky AS. Lower tidal volume strategy ( approximately 3 ml/kg) combined with extracorporeal CO2 removal versus 'conventional' protective ventilation (6 ml/kg) in severe ARDS: the prospective randomized Xtravent-study. Intensive Care Med. 2013 May;39(5):847-56. doi: 10.1007/s00134-012-2787-6. Epub 2013 Jan 10.
PubMed 23306584
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extrapulmonary Interventional Ventilatory Support for Lung Protection in Severe Acute Respiratory Distress - a Prospective Randomized Multi Centre Study
- ClinicalTrials.gov ID
- NCT00538928
- Acronym / sponsor ID
- Xtravent / KKS 4012-001-07
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- acute respiratory distress syndrome, extracorporeal lung support, hypoxia, hypercapnia, acute respiratory distress syndrome (ARDS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of RegensburgUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany
- Study start
- Sep 2007
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 3 Oct 2007 (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.
A prospective, randomized study will be performed investigating the effects of a pumpless extracorporeal interventional lung assist [iLA] on the implementation of a lung-protective ventilatory strategy in patients with acute respiratory distress syndrome [ARDS] with a PaO2/FiO2 ratio < 200. The duration of ventilation, intensive care and hospital stay and in-hospital mortality will be investigated.
Detailed description
Evaluation group:
Implantation of the iLA - adaptation of the ventilation strategy, explantation of the iLA after corresponding improvement (see treatment plan for details) - weaning from the ventilation and extubation according to specified criteria.
Control group:
Ventilation strategy based on the concept of lung-protective ventilation without extracorporeal support, weaning from the ventilation and extubation according to specified criteria (see treatment plan for details).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: lung protective ventilationIntervention: Implantation of the iLA - adaptation of the ventilation strategy, explantation of the iLA after corresponding improvement (see treatment plan for details) - weaning from the ventilation and extubation according to specified criteria. |
| 2 | Active comparator | Other: lung protective ventilationno device: Ventilation strategy based on the concept of lung-protective ventilation without extracorporeal support, weaning from the ventilation and extubation according to specified criteria (see treatment plan for details). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The trial subjects are patients aged 18 years or older who have developed severe ARDS. Following the American-European Consensus Conference on ARDS, severe ARDS is defined as an oxygenation index (PaO2/FIO2) < 200 mmHg. These parameters must be present for a duration of at least 2 hours.
Key exclusion criteria (12 listed)
- age < 18 years
- decompensated heart insufficiency
- acute coronary syndrome
- severe chronic obstructive pulmonary disease
- advanced tumour conditions with life expectancy < 6 months
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 |
|---|---|---|
| lung protective ventilationtidal volume 6 ml/kg ideal body weight | Other | 1, 2 |
Primary outcome
Ventilator free days within 28 days after enrollment
Time frame: 28 days
1 secondary outcome
hospital mortality, organ-failure free days, pulmonary gas exchange
Time frame: 28 days - 60 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 2 Mar 2011.
- Background: PubMed 16540950Bein T, Weber F, Philipp A, Prasser C, Pfeifer M, Schmid FX, Butz B, Birnbaum D, Taeger K, Schlitt HJ. A new pumpless extracorporeal interventional lung assist in critical hypoxemia/hypercapnia. Crit Care Med. 2006 May;34(5):1372-7. doi: 10.1097/01.CCM.0000215111.85483.BD.
- Derived from this study: PubMed 23306584Bein T, Weber-Carstens S, Goldmann A, Muller T, Staudinger T, Brederlau J, Muellenbach R, Dembinski R, Graf BM, Wewalka M, Philipp A, Wernecke KD, Lubnow M, Slutsky AS. Lower tidal volume strategy ( approximately 3 ml/kg) combined with extracorporeal CO2 removal versus 'conventional' protective ventilation (6 ml/kg) in severe ARDS: the prospective randomized Xtravent-study. Intensive Care Med. 2013 May;39(5):847-56. doi: 10.1007/s00134-012-2787-6. Epub 2013 Jan 10.
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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.
Thomas Bein, Professor Dr. principal investigator
University Hospital Regensburg
Steffen Weber-Carstens, Dr. study chair
Charite University Hospital Berlin
Thomas Staudinger, Prof study chair
University Hospital Vienna, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lung protective ventilation in people with Acute Respiratory Distress Syndrome, run by University of Regensburg at 1 site in Germany.
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 1 inclusion and 12 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 2 Mar 2011. 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 Germany. 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?
Ventilator free days within 28 days after enrollment (time frame: 28 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 NCT00538928, 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 2 Mar 2011.