ARDSPhase 1/2NCT01669863
Extracorporeal Membrane Oxygenation (ECMO) in Non-intubated Patients With Acute Respiratory Distress Syndrome (ARDS)
A Phase 1/2 study testing ECMO and ECMO in non-intubated patients in people with ARDS, run by Hannover Medical School at 1 site in Germany.
Trial summary
Proof-of-concept study addressing the feasibility of awake ECMO (v/v) in patients with acute respiratory failure Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ARDS
- What is being tested?
- ECMO and ECMO in non-intubated patients
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2012to Apr 2013
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-75 yrs with acute respiratory failure due to ARDS or pneumonia fulfilling standard criteria for endotracheal intubation
- Severe and progressive hypoxemia, i.e. PaO2 < 60 mmHg or SaO2 < 90% on O2 > 10 l/min not tolerating noninvasive ventilation, or
- PaO2/FiO2 < 200 not improving or deteriorating on noninvasive ventilation, or
- Respiratory distress and hypoxemia not fulfilling the criteria above with clinical impression of the ICU attending that intubation and mechanical ventilation are mandated
- Patient considered eligible by at least two investigators of this study
Who cannot join
- Patient does not fulfill the inclusion criteria
- Uncontrolled malignancy
- Severe and untreatable coagulation or bleeding disorders (INR > 2,0; aPTT > 60s, Platelet count < 50.000/µl, all after substitution)
- Stroke within the past 3 months
- Uncontrolled sepsis or septic shock
- Multiorgan failure involving > 2 organ systems
Show all 14Show fewer
- Norepinephrine dose > 1 mg/h
- Hyperdynamic circulation, indicated by cardiac index > 4.0 l/min/m2 (measured by PiCCO or Swan-Ganz catheter), or SvO2 > 80%
- Cardiac pump failure, indicated by echocardiography (EF < 40%), PiCCO or Swan Ganz catheter (CI < 2,5 l/min/m2 despite adequate volume management), or SvO2 < 50% (provided Hb > 9,0 g/dl and SaO2 > 90%), or the need for inotropes (dobutamine, epinephrine, levosimendan)
- Clinical or echocardiographic signs of pulmonary hypertension with right ventricular dysfunction
- APACHE-II score15 < 25
- Other conditions suggesting that the patient would benefit from intubation and mechanical ventilation
- Severe neurological disorders
- Estimated mortality due to severity of acute and/or underlying illness > 50%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Awake Extracorporeal Membrane Oxygenation (ECMO) for Acute Respiratory Failure A Non-controlled, Single-center, Investigator-initiated Prove-of-concept Study
Proof-of-concept study addressing the feasibility of awake ECMO (v/v) in patients with acute respiratory failure
Read the detailed description
Pilot study in 6 patients with ARDS addressing the use of awake veno-venous ECMO to avoid endotracheal intubation and mechanical ventilation
- Conditions
- ARDS
- Being tested
- ECMO, ECMO in non-intubated patients
- Keywords
- ARDS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECMODevice
Use of veno-venous ECMO in non-intubated patients with ARDS
ECMO in non-intubated patientsProcedure or surgery
Use of veno-venous ECMO in non-intubated patients with ARDS
| Study group | Role | What they receive |
|---|---|---|
| Use of ECMO in non-intubated patients | Experimental | ECMO will be used in non-intubated patients with ARDS Receives: Device: ECMO; Procedure: ECMO in non-intubated patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants That Did Not Require Endotrachael Intubation
- N=6 patients will be enrolled in this exploratory pilot trial; if endotracheal intubation can be avoided in 2 or more of these patients, the trial will be considered positive. In that case, the next step would be a larger trial to better define the patient population with the highest likelihood of responding to this new therapeutic concept.
Measured: Duration of ICU stay
Secondary outcomes (1)
Number of Participants Who Presented With ECMO-Related Complications
ECMO-related complications
Measured: Duration of ICU stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ARDSStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marius Hoeper, MD, Hannover Medical School
- Investigators
- Marius M Hoeper, MD, Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01669863
- Sponsor's protocol ID
- MHH-6208
- Status last verified
- Mar 2015
- First submitted
- 15 Aug 2012
- Last updated
- 23 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Awake Extracorporeal Membrane Oxygenation (ECMO) for Acute Respiratory Failure A Non-controlled, Single-center, Investigator-initiated Prove-of-concept Study
- ClinicalTrials.gov ID
- NCT01669863
- Acronym / sponsor ID
- MHH-6208
- Conditions
- ARDS
- Keywords
- ARDS
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 21 Aug 2012 (estimated)
- Results
- Posted 23 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Proof-of-concept study addressing the feasibility of awake ECMO (v/v) in patients with acute respiratory failure
Detailed description
Pilot study in 6 patients with ARDS addressing the use of awake veno-venous ECMO to avoid endotracheal intubation and mechanical ventilation
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Use of ECMO in non-intubated patients | Experimental | Device: ECMO, Procedure: ECMO in non-intubated patientsECMO will be used in non-intubated patients with ARDS |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18-75 yrs with acute respiratory failure due to ARDS or pneumonia fulfilling standard criteria for endotracheal intubation
- Patient considered eligible by at least two investigators of this study
Key exclusion criteria (14 listed)
- Patient does not fulfill the inclusion criteria
- Uncontrolled malignancy
- Severe and untreatable coagulation or bleeding disorders (INR > 2,0; aPTT > 60s, Platelet count < 50.000/µl, all after substitution)
- Stroke within the past 3 months
- Uncontrolled sepsis or septic shock
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 |
|---|---|---|
| ECMOUse of veno-venous ECMO in non-intubated patients with ARDS | Device | Use of ECMO in non-intubated patients |
| ECMO in non-intubated patientsUse of veno-venous ECMO in non-intubated patients with ARDS | Procedure or surgery | Use of ECMO in non-intubated patients |
Primary outcome
Number of Participants That Did Not Require Endotrachael Intubation
Time frame: Duration of ICU stay
- N=6 patients will be enrolled in this exploratory pilot trial; if endotracheal intubation can be avoided in 2 or more of these patients, the trial will be considered positive. In that case, the next step would be a larger trial to better define the patient population with the highest likelihood of responding to this new therapeutic concept.
1 secondary outcome
Number of Participants Who Presented With ECMO-Related Complications
Time frame: Duration of ICU stay
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Marius M Hoeper, MD principal investigator
Hannover Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ECMO and ECMO in non-intubated patients in people with ARDS, run by Hannover Medical School 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 5 inclusion and 14 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 Apr 2015. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants That Did Not Require Endotrachael Intubation (time frame: Duration of ICU stay). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2015.