Trial · NCT02509078
Reevaluation Of Systemic Early Neuromuscular Blockade
NCT02509078, Phase 3, Completed, Massachusetts General Hospital; results first posted 2019-08-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Reevaluation Of Systemic Early Neuromuscular Blockade. Trials, record NCT02509078. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02509078
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Reevaluation Of Systemic Early Neuromuscular Blockade
- NCT number
- NCT02509078
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,008 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Acute Respiratory Distress Syndrome
- Interventions
- Cisatracurium Besylate
- First posted
- 2015-07-27
- Last updated
- 2019-08-13
- Results first posted
- 2019-08-13
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Hospital Mortality to Day 90 | 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. |
| Secondary | Mean Ventilator Free Days to Day 28 | 28 days after randomization | 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. |
| Secondary | Mean Organ Failure Free Days to Day 28 | 28 days after randomization | 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. |
| Secondary | ICU Free Days to Day 28 | 28 days after randomization | 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). |
| Secondary | Mean Hospital Free Days to Days 28 | 28 days after randomization | 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. |
| Secondary | Katz Activities of Daily Living (ADL)/Lawton Instrumental Activities Of Daily Living Scale (IADL) | 3 months after randomization | 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. |
| Secondary | EuroQol (EQ-5D-5L): Health Related Quality of Life | 3 months after randomization | 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 |
| Secondary | PTSS-14: Post-traumatic Stress-like Symptoms Scores >/= 45 | 6 months after randomization | 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. |
| Secondary | MoCA-Blind: Montreal Cognitive Assessment | 3 months after randomization | 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. |
| Secondary | Katz Activities of Daily Living (ADL)/Lawton Instrumental Activities Of Daily Living Scale (IADL) | 6 months after randomization | 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. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Hospital Mortality to Day 90 | 90 days after randomization | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Mean Ventilator Free Days to Day 28 | 28 days after randomization | The overall number of participants analyzed reflects the number of patients that had sufficient data to allow for calculation of the outcome measure. | days | MEAN |
| SECONDARY | Mean Organ Failure Free Days to Day 28 | 28 days after randomization | The overall number of participants analyzed reflects the number of patients that had sufficient data to allow for calculation of the outcome measure. | days | MEAN |
| SECONDARY | ICU Free Days to Day 28 | 28 days after randomization | The overall number of participants analyzed reflects the number of patients that had sufficient data to allow for calculation of the outcome measure. | days | MEAN |
| SECONDARY | Mean Hospital Free Days to Days 28 | 28 days after randomization | days | MEAN | |
| SECONDARY | Katz Activities of Daily Living (ADL)/Lawton Instrumental Activities Of Daily Living Scale (IADL) | 3 months after randomization | The overall number of participants analyzed reflects the number of patients that were alive, able to be contacted, and had sufficient data to allow for calculation of the outcome measure. | score on a scale | MEAN |
| SECONDARY | EuroQol (EQ-5D-5L): Health Related Quality of Life | 3 months after randomization | The overall number of participants analyzed reflects the number of patients that were alive, able to be contacted, and had sufficient data to allow for calculation of the outcome measure. | score on a scale | MEDIAN |
| SECONDARY | PTSS-14: Post-traumatic Stress-like Symptoms Scores >/= 45 | 6 months after randomization | The overall number of participants analyzed reflects the number of patients that were alive, able to be contacted, and had sufficient data to allow for calculation of the outcome measure. | participants | NUMBER |
| SECONDARY | MoCA-Blind: Montreal Cognitive Assessment | 3 months after randomization | The overall number of participants analyzed reflects the number of patients that were alive, able to be contacted, and had sufficient data to allow for calculation of the outcome measure. | score on a scale | MEAN |
| SECONDARY | Katz Activities of Daily Living (ADL)/Lawton Instrumental Activities Of Daily Living Scale (IADL) | 6 months after randomization | The overall number of participants analyzed reflects the number of patients that were alive, able to be contacted, and had sufficient data to allow for calculation of the outcome measure. | score on a scale | MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Hospital Mortality to Day 90 | Early Neuromuscular Blockade (NMB) | Alive at Day 90 | 288 | Participants | |
| Hospital Mortality to Day 90 | Control: No Routine Early NMB | Alive at Day 90 | 289 | Participants | |
| Hospital Mortality to Day 90 | Early Neuromuscular Blockade (NMB) | Dead Prior to Day 90 | 213 | Participants | |
| Hospital Mortality to Day 90 | Control: No Routine Early NMB | Dead Prior to Day 90 | 216 | Participants | |
| Mean Ventilator Free Days to Day 28 | Early Neuromuscular Blockade (NMB) | 9.6 | Standard Deviation 10.4 | days | |
| Mean Ventilator Free Days to Day 28 | Control: No Routine Early NMB | 9.9 | Standard Deviation 10.9 | days | |
| Mean Organ Failure Free Days to Day 28 | Early Neuromuscular Blockade (NMB) | 12.4 | Standard Deviation 11.3 | days | |
| Mean Organ Failure Free Days to Day 28 | Control: No Routine Early NMB | 12.5 | Standard Deviation 11.5 | days | |
| ICU Free Days to Day 28 | Early Neuromuscular Blockade (NMB) | 9.0 | Standard Deviation 9.4 | days | |
| ICU Free Days to Day 28 | Control: No Routine Early NMB | 9.4 | Standard Deviation 9.8 | days |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Early Neuromuscular Blockade (NMB) | 502 | |
| Overall Study | STARTED | Control: No Routine Early NMB | 506 | |
| Overall Study | COMPLETED | Early Neuromuscular Blockade (NMB) | 501 | |
| Overall Study | COMPLETED | Control: No Routine Early NMB | 505 | |
| Overall Study | NOT COMPLETED | Early Neuromuscular Blockade (NMB) | 1 | |
| Overall Study | NOT COMPLETED | Control: No Routine Early NMB | 1 |
Source ClinicalTrials.gov
Adverse events126
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Atrial Fibrillation Paroxysmal | Cardiac disorders | Early Neuromuscular Blockade (NMB) | 1 | 501 | |
| other | Atrial Fibrillation Paroxysmal | Cardiac disorders | Control: No Routine Early NMB | 0 | 505 | |
| other | Bradycardia | Cardiac disorders | Early Neuromuscular Blockade (NMB) | 1 | 501 | |
| other | Bradycardia | Cardiac disorders | Control: No Routine Early NMB | 0 | 505 | |
| other | Cardiac Arrhythmia (Nos) | Cardiac disorders | Early Neuromuscular Blockade (NMB) | 1 | 501 | |
| other | Cardiac Arrhythmia (Nos) | Cardiac disorders | Control: No Routine Early NMB | 0 | 505 | |
| other | Severe Prolonged Bradycardia | Cardiac disorders | Early Neuromuscular Blockade (NMB) | 1 | 501 | |
| other | Severe Prolonged Bradycardia | Cardiac disorders | Control: No Routine Early NMB | 0 | 505 | |
| other | Tachycardia | Cardiac disorders | Early Neuromuscular Blockade (NMB) | 1 | 501 | |
| other | Tachycardia | Cardiac disorders | Control: No Routine Early NMB | 0 | 505 |
1 to 10 of 126Source ClinicalTrials.gov
See all 126 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Early Neuromuscular Blockade (NMB) | 213 | 501 |
| Total, all-cause mortality | Control: No Routine Early NMB | 216 | 505 |
| Total, other adverse events | Early Neuromuscular Blockade (NMB) | 19 | 501 |
| Total, other adverse events | Control: No Routine Early NMB | 15 | 505 |
| Total, serious adverse events | Early Neuromuscular Blockade (NMB) | 28 | 501 |
| Total, serious adverse events | Control: No Routine Early NMB | 21 | 505 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01HL123009 | CCC for NHLBI Prevention and Early Treatment of Acute Lung Injury PETAL Network | THOMPSON, BOYD TAYLOR; FOULKES, ANDREA S | MASSACHUSETTS GENERAL HOSPITAL | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2014 to 2021 |
Source NIH RePORTER
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Early Neuromuscular Blockade (NMB) vs Control: No Routine Early NMB: PTSS-14: Post-traumatic Stress-like Symptoms Scores >/= 45 | Trial comparisons |
| Early Neuromuscular Blockade (NMB) vs Control: No Routine Early NMB: PTSS-14: Post-traumatic Stress-like Symptoms Scores >/= 45 | Trial comparisons |
| Early Neuromuscular Blockade (NMB) vs Control: No Routine Early NMB: deaths from any cause | Trial comparisons |
| Early Neuromuscular Blockade (NMB) vs Control: No Routine Early NMB: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02509078
GET https://conductscience.org/api/trials/v1/NCT02509078/results?page=2