Acute Respiratory Distress SyndromePhase 3ROSENCT02509078
Reevaluation Of Systemic Early Neuromuscular Blockade
A Phase 3 study testing Cisatracurium Besylate in people with Acute Respiratory Distress Syndrome, run by Massachusetts General Hospital at 44 sites in United States.
Trial summary
This study evaluates whether giving a neuromuscular blocker (skeletal muscle relaxant) to a patient with acute respiratory distress syndrome will improve survival. Half of the patients will receive a neuromuscular blocker for two days and in the other half the use of neuromuscular blockers will be discouraged. 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?
- Cisatracurium Besylate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,008 participants
- Where
- 44 sitesUnited States
- Study dates
- 4 Jan 2016to 4 Apr 2019
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Presence of all of the following conditions for < 48 hours:
- PaO2/FiO2 < 150 with PEEP >/= 8 cm H2O OR, if ABG not available, SaO2/FiO2 ratio that is equivalent to a PaO2/FiO2 < 150 with PEEP >/= 8 cm H2O , and a confirmatory SaO2/FiO2 ratio that is again equivalent 1-6 hours later
- Bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules.
- Respiratory failure not fully explained by cardiac failure or fluid overload; need objective assessment (e.g., echocardiography) to exclude hydrostatic edema if no risk factor present.
- Patients must be enrolled within 48 hours of meeting inclusion criteria.
Who cannot join
- Lack of informed consent
- Continuous neuromuscular blockade at enrollment
- Known pregnancy
- Currently receiving ECMO therapy
- Chronic respiratory failure defined as PaCO2 > 60 mm Hg in the outpatient setting
- Home mechanical ventilation (non-invasive ventilation or via tracheotomy) except for CPAP/BIPAP used solely for sleep-disordered breathing
Show all 21Show fewer
- Actual body weight exceeding 1 kg per centimeter of height
- Severe chronic liver disease defined as a Child-Pugh score of 12-15 (Appendix A2)
- Bone marrow transplantation within the last 1 year
- Expected duration of mechanical ventilation of < 48 hours
- Decision to withhold life-sustaining treatment; except in those patients committed to full support except cardiopulmonary resuscitation if an actual cardiac arrest occurs
- Moribund patient not expected to survive 24 hours; if CPR provided, assess for moribund status greater than 6 from CPR conclusion
- Diffuse alveolar hemorrhage from vasculitis
- Burns > 70% total body surface
- Unwillingness to utilize the ARDS Network 6 ml/kg IBW ventilation protocol
- Previous hypersensitivity or anaphylactic reaction to cisatracurium
- Neuromuscular conditions that may potentiate neuromuscular blockade and/or impair spontaneous ventilation (Appendix A2)
- Neurologic conditions undergoing treatment for intracranial hypertension
- Enrollment in an interventional ARDS trial with direct impact on neuromuscular blockade and PEEP
- >120 hours of mechanical ventilation
- P/F < 200 mmHg at the time of randomization (if available)
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
United States44 sites
Summa Akron City Hospital
Akron, Ohio, 44304
University of Michigan Medical Center
Ann Arbor, Michigan, 48109
Medical Center of Aurora
Aurora, Colorado, 80045
University of Colorado Hospital
Aurora, Colorado, 80045
Tufts Medical Center
Boston, Massachusetts, 02111
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University or Virginia Health System
Charlottesville, Virginia, 22903
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Denver Health Medical Center
Denver, Colorado, 80204
Henry Ford Medical Center
Detroit, Michigan, 48025
Swedish Medical Center
Englewood, Colorado, 80113
UCSF Fresno
Fresno, California, 93701
Wesley Long Hospital
Greensboro, North Carolina, 27403
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
Indiana University Methodist Hospital
Indianapolis, Indiana, 46220
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
Intermountain Medical Center
Murray, Utah, 84107
Vanderbilt University Medical Center
Nashville, Tennessee, 37221
University Medical Center
New Orleans, Louisiana, 70112
Mt. Sinai Hospital
New York, New York, 10029
McKay-Dee Hospital
Ogden, Utah, 84403
UPMC Presbyterian/Mercy/Shadyside
Pittsburgh, Pennsylvania, 15261
Maine Medical Center
Portland, Maine, 04102
Oregon Health and Science University
Portland, Oregon, 97239
Utah Valley Regional Medical Center
Provo, Utah, 84604
VCU Medical Center
Richmond, Virginia, 23298
UC Davis Medical Center
Sacramento, California, 95817
University Hospital
Salt Lake City, Utah, 84132
LDS Hospital
Salt Lake City, Utah, 84143
UCSF Medical Center
San Francisco, California, 94143
Harborview Medical Center
Seattle, Washington, 98104
University of Washington Medical Center
Seattle, Washington, 98104
Swedish Hospital Cherry Hill
Seattle, Washington, 98122
Swedish Hospital First Hill
Seattle, Washington, 98122
Baystate Medical Center
Springfield, Massachusetts, 01199
Stanford University Hospital
Stanford, California, 94305
Montefiore Medical Center
The Bronx, New York, 10467
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
St. Vincent's Hospital
Worcester, Massachusetts, 01608
About this study
This study evaluates whether giving a neuromuscular blocker (skeletal muscle relaxant) to a patient with acute respiratory distress syndrome will improve survival. Half of the patients will receive a neuromuscular blocker for two days and in the other half the use of neuromuscular blockers will be discouraged.
Read the detailed description
PRIMARY OBJECTIVE:
To assess the efficacy and safety of early neuromuscular blockade in reducing mortality and morbidity in patients with moderate-severe ARDS, in comparison to a control group with no routine early neuromuscular blockade (NMB).
PRIMARY HYPOTHESIS:
Early neuromuscular blockade will improve mortality prior to discharge home before day 90, in patients with moderate-severe ARDS.
The trial will accrue a maximum of 1408 patients. Patients will be recruited from the emergency departments, intensive care units and other acute care areas of the PETAL Network Clinical Centers and randomized to the active (NMB) or control. The overall strategy is to screen, consent, and enroll early, every newly intubated, acutely ill or post-operative, eligible patient at each site, using clinically obtained pulse oximetry and blood gases.
By preventing active expiration, and/or patient ventilator dyssynchrony, neuromuscular blockade may create a more homogenous distribution of airway pressures and tidal volumes, preventing barotrauma/volutrauma and "atelectrauma" resulting in less ventilator-induced lung injury.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- Cisatracurium Besylate
- Keywords
- ARDS, neuromuscular blocker, cisatracurium
- 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.
Cisatracurium BesylateDrug
Also called Nimbex
Patients randomized to the early neuromuscular blockade arm will receive a cisatracurium besylate bolus of 15 mg, followed by a continuous infusion of 37.5 mg/hour for 48 hours. Patients randomized to the control arm will receive no protocol specified neuromuscular blockade.
| Study group | Role | What they receive |
|---|---|---|
| Early Neuromuscular Blockade (NMB) | Active comparator | Patients will receive cisatracurium besylate for the first 48 hours of the trial. Receives: Drug: Cisatracurium Besylate |
| Control: No Routine Early NMB | No intervention | Use of non-study NMB will be discouraged. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Mortality to Day 90
The percentage of subjects alive at study day 90. Those subjects discharged home prior to day 90 were counted as alive at day 90.
Measured: 90 days after randomization
Secondary outcomes (15)
Mean Ventilator Free Days to Day 28
Ventilator-free days is defined to be 28 days minus the duration of mechanical ventilation through day 28. Participants who do not survive to day 28 are assigned zero ventilator-free days.
Measured: 28 days after randomization
Mean Organ Failure Free Days to Day 28
SOFA (Sepsis-related Organ Failure Assessment) was used to determine criteria for an organ failure free day. Scores were based on four of the six SOFA organ categories: Coagulation, Liver, Cardiovascular, and Renal. Each category was scored 0-4; 0 being normal functioning and 4 being the most abnormal. A patient was considered failure free on each day alive with SOFA scores below 2 for all four organ systems.
Ref: Vincent, J.L., et al., The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med, 1996. 22(7): p. 707-10.
Measured: 28 days after randomization
ICU Free Days to Day 28
ICU free days is defined as the number of days between randomization and day 28 in which the patient is in the ICU (for any part of a day).
Measured: 28 days after randomization
Mean Hospital Free Days to Days 28
Hospital free days are days alive post hospital discharge through day 28. Patients who die on or prior to day 28 are assigned zero hospital free days.
Measured: 28 days after randomization
Katz Activities of Daily Living (ADL)/Lawton Instrumental Activities Of Daily Living Scale (IADL)
Assesses whether individual can living independently and assess a range of common functional activities, from walking and toileting to managing money and cooking meals. Data is a pooled estimates from patient survey and proxy survey. The total score is rated from 0 to 10 (MCID=1; 1 point=1 ADL); a higher score indicates having more difficulties in daily activities.
Measured: 3 months after randomization
EuroQol (EQ-5D-5L): Health Related Quality of Life
Using a standardized scale, do health reasons limit the person's ability to enjoy their life? Pooled estimates from patient survey and proxy survey were used. Utility index was computed from a lookup table according to EQ-5D-5L response profiles; utility index ranges from -0.11 to 1.00 (higher scores are better; 1.00 is perfect health), minimal clinically important difference (MCID) is 0.07
Measured: 3 months after randomization
PTSS-14: Post-traumatic Stress-like Symptoms Scores >/= 45
Does the patient have symptoms of anxiety and stress from their ICU stay? PTSS-14 is only asked at month 6 and month 12 in patient survey; total score is rated from 14 to 98 and a higher score indicates having more post-traumatic stress syndrome related symptoms. Participants with scores greater than or equal to 45 were reported.
Measured: 6 months after randomization
MoCA-Blind: Montreal Cognitive Assessment
How clearly can patient think and recall things? MoCA-Blind is only asked in patient survey; total score is rated from 0 to 30 and a higher score indicates better cognitive performance. Normal range: 26 or greater.
Measured: 3 months after randomization
Katz Activities of Daily Living (ADL)/Lawton Instrumental Activities Of Daily Living Scale (IADL)
Assesses whether individual can living independently and assess a range of common functional activities, from walking and toileting to managing money and cooking meals. Data is a pooled estimates from patient survey and proxy survey. The total score is rated from 0 to 10 (MCID=1; 1 point=1 ADL); a higher score indicates having more difficulties in daily activities.
Measured: 6 months after randomization
Katz Activities of Daily Living (ADL)/Lawton Instrumental Activities Of Daily Living Scale (IADL)
Assesses whether individual can living independently and assess a range of common functional activities, from walking and toileting to managing money and cooking meals. Data is a pooled estimates from patient survey and proxy survey. The total score is rated from 0 to 10 (MCID=1; 1 point=1 ADL); a higher score indicates having more difficulties in daily activities.
Measured: 12 months after randomization
EuroQol (EQ-5D-5L): Health Related Quality of Life
Using a standardized scale, do health reasons limit the person's ability to enjoy their life? Pooled estimates from patient survey and proxy survey were used. Utility index was computed from a lookup table according to EQ-5D-5L response profiles; utility index ranges from -0.11 to 1.00 (higher scores are better; 1.00 is perfect health), minimal clinically important difference (MCID) is 0.07
Measured: 6 months after randomization
EuroQol (EQ-5D-5L): Health Related Quality of Life
Using a standardized scale, do health reasons limit the person's ability to enjoy their life? Pooled estimates from patient survey and proxy survey were used. Utility index was computed from a lookup table according to EQ-5D-5L response profiles; utility index ranges from -0.11 to 1.00 (higher scores are better; 1.00 is perfect health), minimal clinically important difference (MCID) is 0.07
Measured: 12 months after randomization
MoCA-Blind: Montreal Cognitive Assessment
How clearly can patient think and recall things? MoCA-Blind is only asked in patient survey; total score is rated from 0 to 30 and a higher score indicates better cognitive performance. Normal range:
26 or greater.
Measured: 6 months after randomization
MoCA-Blind: Montreal Cognitive Assessment
How clearly can patient think and recall things? MoCA-Blind is only asked in patient survey; total score is rated from 0 to 30 and a higher score indicates better cognitive performance. Normal range:
26 or greater.
Measured: 12 months after randomization
PTSS-14: Post-traumatic Stress-like Symptoms Scores >/= 45
Does the patient have symptoms of anxiety and stress from their ICU stay? PTSS-14 is only asked at month 6 and month 12 in patient survey; total score is rated from 14 to 98 and a higher score indicates having more post-traumatic stress syndrome related symptoms. Participants with scores greater than or equal to 45 were reported.
Measured: 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2015 (estimated)
- Study start4 Jan 2016
- Primary completion3 Jul 2018
- Study completion4 Apr 2019
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.
- Publications (3)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 Massachusetts General HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,008 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Boyd Taylor Thompson, Massachusetts General Hospital
- Investigators
- David A. Schoenfeld, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02509078
- Sponsor's protocol ID
- PETAL01ROSE
- Other IDs
- 1U01HL123009-01
- Acronym
- ROSE
- Status last verified
- Jul 2019
- First submitted
- 24 Jul 2015
- Last updated
- 13 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data will be collected electronically and stored at the Clinical Coordinating Center at MGH. A de-identified database of all data will be available for use 3 years after the primary publication. Data can be accessed at that point via the NHLBI BioLINCC data repository.
Publications
National Heart, Lung, and Blood Institute PETAL Clinical Trials Network; Moss M, Huang DT, Brower RG, Ferguson ND, Ginde AA, Gong MN, Grissom CK, Gundel S, Hayden D, Hite RD, Hou PC, Hough CL, Iwashyna TJ, Khan A, Liu KD, Talmor D, Thompson BT, Ulysse CA, Yealy DM, Angus DC. Early Neuromuscular Blockade in the Acute Respiratory Distress Syndrome. N Engl J Med. 2019 May 23;380(21):1997-2008. doi: 10.1056/NEJMoa1901686. Epub 2019 May 19.
PubMed 31112383Sjoding MW, Schoenfeld DA, Brown SM, Hough CL, Yealy DM, Moss M, Angus DC, Iwashyna TJ; NHLBI Prevention and Early Treatment of Acute Lung Injury (PETAL) Network. Power Calculations to Select Instruments for Clinical Trial Secondary Endpoints. A Case Study of Instrument Selection for Post-Traumatic Stress Symptoms in Subjects with Acute Respiratory Distress Syndrome. Ann Am Thorac Soc. 2017 Jan;14(1):110-117. doi: 10.1513/AnnalsATS.201608-585OC.
PubMed 27788018Huang DT, Angus DC, Moss M, Thompson BT, Ferguson ND, Ginde A, Gong MN, Gundel S, Hayden DL, Hite RD, Hou PC, Hough CL, Iwashyna TJ, Liu KD, Talmor DS, Yealy DM; Reevaluation of Systemic Early Neuromuscular Blockade Protocol Committee and the National Institutes of Health National Heart, Lung, and Blood Institute Prevention and Early Treatment of Acute Lung Injury Network Investigators. Design and Rationale of the Reevaluation of Systemic Early Neuromuscular Blockade Trial for Acute Respiratory Distress Syndrome. Ann Am Thorac Soc. 2017 Jan;14(1):124-133. doi: 10.1513/AnnalsATS.201608-629OT.
PubMed 27779896
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reevaluation Of Systemic Early Neuromuscular Blockade
- ClinicalTrials.gov ID
- NCT02509078
- Acronym / sponsor ID
- ROSE / PETAL01ROSE
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- ARDS, neuromuscular blocker, cisatracurium
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,008 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 4 Jan 2016 (actual)
- Primary completion
- 3 Jul 2018 (actual)
- Study completion
- 4 Apr 2019 (actual)
- First posted
- 27 Jul 2015 (estimated)
- Results
- Posted 13 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates whether giving a neuromuscular blocker (skeletal muscle relaxant) to a patient with acute respiratory distress syndrome will improve survival. Half of the patients will receive a neuromuscular blocker for two days and in the other half the use of neuromuscular blockers will be discouraged.
Detailed description
PRIMARY OBJECTIVE:
To assess the efficacy and safety of early neuromuscular blockade in reducing mortality and morbidity in patients with moderate-severe ARDS, in comparison to a control group with no routine early neuromuscular blockade (NMB).
PRIMARY HYPOTHESIS:
Early neuromuscular blockade will improve mortality prior to discharge home before day 90, in patients with moderate-severe ARDS.
The trial will accrue a maximum of 1408 patients. Patients will be recruited from the emergency departments, intensive care units and other acute care areas of the PETAL Network Clinical Centers and randomized to the active (NMB) or control. The overall strategy is to screen, consent, and enroll early, every newly intubated, acutely ill or post-operative, eligible patient at each site, using clinically obtained pulse oximetry and blood gases.
By preventing active expiration, and/or patient ventilator dyssynchrony, neuromuscular blockade may create a more homogenous distribution of airway pressures and tidal volumes, preventing barotrauma/volutrauma and "atelectrauma" resulting in less ventilator-induced lung injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Neuromuscular Blockade (NMB) | Active comparator | Drug: Cisatracurium BesylatePatients will receive cisatracurium besylate for the first 48 hours of the trial. |
| Control: No Routine Early NMB | No intervention | –Use of non-study NMB will be discouraged. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > 18 years
- Presence of all of the following conditions for < 48 hours:
- Bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules.
- Respiratory failure not fully explained by cardiac failure or fluid overload; need objective assessment (e.g., echocardiography) to exclude hydrostatic edema if no risk factor present.
- Patients must be enrolled within 48 hours of meeting inclusion criteria.
Key exclusion criteria (21 listed)
- Lack of informed consent
- Continuous neuromuscular blockade at enrollment
- Known pregnancy
- Currently receiving ECMO therapy
- Chronic respiratory failure defined as PaCO2 > 60 mm Hg in the outpatient setting
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 |
|---|---|---|
| Cisatracurium BesylateAlso: NimbexPatients randomized to the early neuromuscular blockade arm will receive a cisatracurium besylate bolus of 15 mg, followed by a continuous infusion of 37.5 mg/hour for 48 hours. Patients randomized to the control arm will receive no protocol specified neuromuscular blockade. | Drug | Early Neuromuscular Blockade (NMB) |
Primary outcome
Hospital Mortality to Day 90
Time frame: 90 days after randomization
The percentage of subjects alive at study day 90. Those subjects discharged home prior to day 90 were counted as alive at day 90.
15 secondary outcomes
Mean Ventilator Free Days to Day 28
Time frame: 28 days after randomization
Mean Organ Failure Free Days to Day 28
Time frame: 28 days after randomization
ICU Free Days to Day 28
Time frame: 28 days after randomization
Mean Hospital Free Days to Days 28
Time frame: 28 days after randomization
Katz Activities of Daily Living (ADL)/Lawton Instrumental Activities Of Daily Living Scale (IADL)
Time frame: 3 months after randomization
EuroQol (EQ-5D-5L): Health Related Quality of Life
Time frame: 3 months after randomization
PTSS-14: Post-traumatic Stress-like Symptoms Scores >/= 45
Time frame: 6 months after randomization
MoCA-Blind: Montreal Cognitive Assessment
Time frame: 3 months after randomization
Katz Activities of Daily Living (ADL)/Lawton Instrumental Activities Of Daily Living Scale (IADL)
Time frame: 6 months after randomization
Katz Activities of Daily Living (ADL)/Lawton Instrumental Activities Of Daily Living Scale (IADL)
Time frame: 12 months after randomization
EuroQol (EQ-5D-5L): Health Related Quality of Life
Time frame: 6 months after randomization
EuroQol (EQ-5D-5L): Health Related Quality of Life
Time frame: 12 months after randomization
MoCA-Blind: Montreal Cognitive Assessment
Time frame: 6 months after randomization
MoCA-Blind: Montreal Cognitive Assessment
Time frame: 12 months after randomization
PTSS-14: Post-traumatic Stress-like Symptoms Scores >/= 45
Time frame: 12 months after randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31112383National Heart, Lung, and Blood Institute PETAL Clinical Trials Network; Moss M, Huang DT, Brower RG, Ferguson ND, Ginde AA, Gong MN, Grissom CK, Gundel S, Hayden D, Hite RD, Hou PC, Hough CL, Iwashyna TJ, Khan A, Liu KD, Talmor D, Thompson BT, Ulysse CA, Yealy DM, Angus DC. Early Neuromuscular Blockade in the Acute Respiratory Distress Syndrome. N Engl J Med. 2019 May 23;380(21):1997-2008. doi: 10.1056/NEJMoa1901686. Epub 2019 May 19.
- Derived from this study: PubMed 27788018Sjoding MW, Schoenfeld DA, Brown SM, Hough CL, Yealy DM, Moss M, Angus DC, Iwashyna TJ; NHLBI Prevention and Early Treatment of Acute Lung Injury (PETAL) Network. Power Calculations to Select Instruments for Clinical Trial Secondary Endpoints. A Case Study of Instrument Selection for Post-Traumatic Stress Symptoms in Subjects with Acute Respiratory Distress Syndrome. Ann Am Thorac Soc. 2017 Jan;14(1):110-117. doi: 10.1513/AnnalsATS.201608-585OC.
- Derived from this study: PubMed 27779896Huang DT, Angus DC, Moss M, Thompson BT, Ferguson ND, Ginde A, Gong MN, Gundel S, Hayden DL, Hite RD, Hou PC, Hough CL, Iwashyna TJ, Liu KD, Talmor DS, Yealy DM; Reevaluation of Systemic Early Neuromuscular Blockade Protocol Committee and the National Institutes of Health National Heart, Lung, and Blood Institute Prevention and Early Treatment of Acute Lung Injury Network Investigators. Design and Rationale of the Reevaluation of Systemic Early Neuromuscular Blockade Trial for Acute Respiratory Distress Syndrome. Ann Am Thorac Soc. 2017 Jan;14(1):124-133. doi: 10.1513/AnnalsATS.201608-629OT.
- Website for the PETAL NetworkLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data will be collected electronically and stored at the Clinical Coordinating Center at MGH. A de-identified database of all data will be available for use 3 years after the primary publication. Data can be accessed at that point via the NHLBI BioLINCC data repository.
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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.
David A. Schoenfeld, PhD principal investigator
Massachusetts General Hospital
44 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 Cisatracurium Besylate in people with Acute Respiratory Distress Syndrome, run by Massachusetts General Hospital at 44 sites in United States.
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 6 inclusion and 21 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 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States. 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?
Yes. Results are posted in the registry (first posted 13 Aug 2019). 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?
Hospital Mortality to Day 90 (time frame: 90 days after randomization). 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 NCT02509078, which also lists 3 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 13 Aug 2019.