Acute Respiratory Distress SyndromePhase 4NCT01573715
Effects of Neuromuscular Blocking Agents (NMBA) on the Alteration of Transpulmonary Pressures at the Early Phase of Acute Respiratory Distress Syndrome (ARDS)
A Phase 4 study testing NIMBEX and WITHOUT NIMBEX in people with Acute Respiratory Distress Syndrome, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Mortality in Acute Respiratory Distress Syndrome is high (40 to 60 %). Protective mechanical ventilation, until 2010, was the cornerstone of the ARDS therapeutic strategies. Recently, a prospective multicenter study demonstrates that a 48h continuous infusion of neuromuscular blocking agents (NMBA) have a positive… 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?
- NIMBEX and WITHOUT NIMBEX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2012to Dec 2014
- Phase
- Phase 4
- 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
- Early (< 48H) Severe ARDS: PaO2 / FiO2 ratio < 150 with PEEP >= 5 cmH20
Who cannot join
- Age < 18 ans Patient already under continuous infusion NMBA. Known NMBA Allergy or intolerance Contra-indication to introduction of nasogastric tube
Trial locations and contacts
1 site in 1 country.
magali BISBAL contact
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hopitaux de Marseille
Marseille, 13354
magali BISBAL, magali.bisbal@ap-hm.fr
magali BISBAL
About this study
Official title: Effects of NMBA on the Alteration of Transpulmonary Pressures at the Early Phase of ARDS
Mortality in Acute Respiratory Distress Syndrome is high (40 to 60 %). Protective mechanical ventilation, until 2010, was the cornerstone of the ARDS therapeutic strategies. Recently, a prospective multicenter study demonstrates that a 48h continuous infusion of neuromuscular blocking agents (NMBA) have a positive impact on mortality of ARDS patients. (Papazian et al. ACURASYS Study. NEJM 2010; 363:1107-16). The mechanisms through which NMBAs could improve survival remain speculative. They are as follows:
- reduction of the consumption of oxygen linked to ventilatory workload;
- increase of chest wall compliance improving mechanical ventilation during ARDS and better adaptation to the protective ventilation strategy;
- anti-inflammatory effect contributing to a reduction in pulmonary inflammation and improvement in oxygenation,
- reduction of the variations of transpulmonary pressure (TPP) by the way of better synchronisation between patient and the ventilator.
The use of NMBA could also reduce the ventilator induced lung injury by a better control of TPP.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- NIMBEX, WITHOUT NIMBEX
- 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.
NIMBEXDrug
NIMBEXDrug
WITHOUT NIMBEXOther
| Study group | Role | What they receive |
|---|---|---|
| severe ARDS patients | Active comparator | Not described Receives: Drug: NIMBEX |
| control group | Active comparator | Not described Receives: Drug: NIMBEX; Other: WITHOUT NIMBEX |
| moderate SDRA patients | Experimental | Not described Receives: Drug: NIMBEX; Other: WITHOUT NIMBEX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delta TPP
Reduction of Delta TPP at 48 hr in the NMBA group by comparison with the control group in ARDS patients
Measured: 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionSep 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BERNARD BELAIGUES, Study director, Assistance Publique hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01573715
- Sponsor's protocol ID
- 2011-005720-18
- Other IDs
- 2011-39
- Status last verified
- Aug 2014
- First submitted
- 5 Apr 2012
- Last updated
- 1 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of NMBA on the Alteration of Transpulmonary Pressures at the Early Phase of ARDS
- ClinicalTrials.gov ID
- NCT01573715
- Acronym / sponsor ID
- 2011-005720-18
- Conditions
- Acute Respiratory Distress Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 9 Apr 2012 (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.
Mortality in Acute Respiratory Distress Syndrome is high (40 to 60 %). Protective mechanical ventilation, until 2010, was the cornerstone of the ARDS therapeutic strategies. Recently, a prospective multicenter study demonstrates that a 48h continuous infusion of neuromuscular blocking agents (NMBA) have a positive impact on mortality of ARDS patients. (Papazian et al. ACURASYS Study. NEJM 2010; 363:1107-16). The mechanisms through which NMBAs could improve survival remain speculative. They are as follows:
- reduction of the consumption of oxygen linked to ventilatory workload;
- increase of chest wall compliance improving mechanical ventilation during ARDS and better adaptation to the protective ventilation strategy;
- anti-inflammatory effect contributing to a reduction in pulmonary inflammation and improvement in oxygenation,
- reduction of the variations of transpulmonary pressure (TPP) by the way of better synchronisation between patient and the ventilator.
The use of NMBA could also reduce the ventilator induced lung injury by a better control of TPP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| severe ARDS patients | Active comparator | Drug: NIMBEX |
| control group | Active comparator | Drug: NIMBEX, Other: WITHOUT NIMBEX |
| moderate SDRA patients | Experimental | Drug: NIMBEX, Other: WITHOUT NIMBEX |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Early (< 48H) Severe ARDS: PaO2 / FiO2 ratio < 150 with PEEP >= 5 cmH20
Key exclusion criteria (1 listed)
- Age < 18 ans Patient already under continuous infusion NMBA. Known NMBA Allergy or intolerance Contra-indication to introduction of nasogastric tube
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 |
|---|---|---|
| NIMBEX | Drug | severe ARDS patients |
| NIMBEX | Drug | control group, moderate SDRA patients |
| WITHOUT NIMBEX | Other | control group, moderate SDRA patients |
Primary outcome
Delta TPP
Time frame: 27 months
Reduction of Delta TPP at 48 hr in the NMBA group by comparison with the control group in ARDS patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2014.
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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.
magali BISBAL contact
BERNARD BELAIGUES study director
Assistance Publique hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing NIMBEX and WITHOUT NIMBEX in people with Acute Respiratory Distress Syndrome, run by Assistance Publique Hopitaux De Marseille at 1 site 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 1 Sep 2014. 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 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact magali BISBAL (magali.bisbal@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delta TPP (time frame: 27 months). 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 1 Sep 2014.