| Primary | 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. | | Posted | | Count of Participants | | Participants | | 90 days after randomization | | | | ID | Title | Description |
|---|
| OG000 | Early Neuromuscular Blockade (NMB) | Patients will receive cisatracurium besylate for the first 48 hours of the trial. cisatracurium besylate: 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. | | OG001 | Control: No Routine Early NMB | Use of non-study NMB will be discouraged. Patients randomized to the control arm will receive no protocol specified neuromuscular blockade. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| Alive at Day 90 | | | Dead Prior to Day 90 | |
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Wald test for the difference of two prop | | 0.93 | | Risk Difference (RD) | -0.3 | | | 2-Sided | 95 | -6.4 | 5.9 | | | Estimated value is a percentage | | Superiority | | |
|
| Secondary | 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. | The overall number of participants analyzed reflects the number of patients that had sufficient data to allow for calculation of the outcome measure. | Posted | | Mean | Standard Deviation | days | | 28 days after randomization | | | | ID | Title | Description |
|---|
| OG000 | Early Neuromuscular Blockade (NMB) | Patients will receive cisatracurium besylate for the first 48 hours of the trial. cisatracurium besylate: 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. | | OG001 | Control: No Routine Early NMB | Use of non-study NMB will be discouraged. Patients randomized to the control arm will receive no protocol specified neuromuscular blockade. |
| |
| Secondary | 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. | The overall number of participants analyzed reflects the number of patients that had sufficient data to allow for calculation of the outcome measure. | Posted | | Mean | Standard Deviation | days | | 28 days after randomization | | | | ID | Title | Description |
|---|
| OG000 | Early Neuromuscular Blockade (NMB) | Patients will receive cisatracurium besylate for the first 48 hours of the trial. cisatracurium besylate: 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. | | OG001 | Control: No Routine Early NMB | Use of non-study NMB will be discouraged. Patients randomized to the control arm will receive no protocol specified neuromuscular blockade. |
|
| Secondary | 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). | The overall number of participants analyzed reflects the number of patients that had sufficient data to allow for calculation of the outcome measure. | Posted | | Mean | Standard Deviation | days | | 28 days after randomization | | | | ID | Title | Description |
|---|
| OG000 | Early Neuromuscular Blockade (NMB) | Patients will receive cisatracurium besylate for the first 48 hours of the trial. cisatracurium besylate: 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. | | OG001 | Control: No Routine Early NMB | Use of non-study NMB will be discouraged. Patients randomized to the control arm will receive no protocol specified neuromuscular blockade. |
| |
| Secondary | 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. | | Posted | | Mean | Standard Deviation | days | | 28 days after randomization | | | | ID | Title | Description |
|---|
| OG000 | Early Neuromuscular Blockade (NMB) | Patients will receive cisatracurium besylate for the first 48 hours of the trial. cisatracurium besylate: 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. | | OG001 | Control: No Routine Early NMB | Use of non-study NMB will be discouraged. Patients randomized to the control arm will receive no protocol specified neuromuscular blockade. |
| |
| Secondary | 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. | 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. | Posted | | Mean | Standard Deviation | score on a scale | | 3 months after randomization | | | | ID | Title | Description |
|---|
| OG000 | Early Neuromuscular Blockade (NMB) | Patients will receive cisatracurium besylate for the first 48 hours of the trial. cisatracurium besylate: 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. | | OG001 | Control: No Routine Early NMB | Use of non-study NMB will be discouraged. |
| |
| Secondary | 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 | 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. | Posted | | Median | Inter-Quartile Range | score on a scale | | 3 months after randomization | | | | ID | Title | Description |
|---|
| OG000 | Early Neuromuscular Blockade (NMB) | Patients will receive cisatracurium besylate for the first 48 hours of the trial. cisatracurium besylate: 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. | | OG001 | Control: No Routine Early NMB | Use of non-study NMB will be discouraged. |
| |
| Secondary | 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. | 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. | Posted | | Number | | participants | | 6 months after randomization | | | | ID | Title | Description |
|---|
| OG000 | Early Neuromuscular Blockade (NMB) | Patients will receive cisatracurium besylate for the first 48 hours of the trial. cisatracurium besylate: 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. | | OG001 | Control: No Routine Early NMB | Use of non-study NMB will be discouraged. |
| |
| Secondary | 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. | 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. | Posted | | Mean | Standard Deviation | score on a scale | | 3 months after randomization | | | | ID | Title | Description |
|---|
| OG000 | Early Neuromuscular Blockade (NMB) | Patients will receive cisatracurium besylate for the first 48 hours of the trial. cisatracurium besylate: 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. | | OG001 | Control: No Routine Early NMB | Use of non-study NMB will be discouraged. |
| |
| Secondary | 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. | 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. | Posted | | Mean | Standard Deviation | score on a scale | | 6 months after randomization | | | | ID | Title | Description |
|---|
| OG000 | Early Neuromuscular Blockade (NMB) | Patients will receive cisatracurium besylate for the first 48 hours of the trial. cisatracurium besylate: 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. | | OG001 | Control: No Routine Early NMB | Use of non-study NMB will be discouraged. |
| |
| Secondary | 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. | 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. | Posted | | Mean | Standard Deviation | score on a scale | | 12 months after randomization | | | | ID | Title | Description |
|---|
| OG000 | Early Neuromuscular Blockade (NMB) | Patients will receive cisastracurium besylate for the first 48 hours of the trial. cisastracurium besylate: Patients randomized to the early neuromuscular blockade arm will receive a cisastracurium 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. | | OG001 | Control: No Routine Early NMB | Use of non-study NMB will be discouraged. |
| |
| Secondary | 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 | 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. | Posted | | Median | Inter-Quartile Range | score on a scale | | 6 months after randomization | | | | ID | Title | Description |
|---|
| OG000 | Early Neuromuscular Blockade (NMB) | Patients will receive cisatracurium besylate for the first 48 hours of the trial. cisatracurium besylate: 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. | | OG001 | Control: No Routine Early NMB | Use of non-study NMB will be discouraged. |
| |
| Secondary | 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 | 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. | Posted | | Median | Inter-Quartile Range | score on a scale | | 12 months after randomization | | | | ID | Title | Description |
|---|
| OG000 | Early Neuromuscular Blockade (NMB) | Patients will receive cisatracurium besylate for the first 48 hours of the trial. cisatracurium besylate: 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. | | OG001 | Control: No Routine Early NMB | Use of non-study NMB will be discouraged. |
| |
| Secondary | 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. | 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. | Posted | | Mean | Standard Deviation | score on a scale | | 6 months after randomization | | | | ID | Title | Description |
|---|
| OG000 | Early Neuromuscular Blockade (NMB) | Patients will receive cisatracurium besylate for the first 48 hours of the trial. cisatracurium besylate: 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. | | OG001 | Control: No Routine Early NMB | Use of non-study NMB will be discouraged. |
| |
| Secondary | 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. | 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. | Posted | | Mean | Standard Deviation | score on a scale | | 12 months after randomization | | | | ID | Title | Description |
|---|
| OG000 | Early Neuromuscular Blockade (NMB) | Patients will receive cisatracurium besylate for the first 48 hours of the trial. cisatracurium besylate: 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. | | OG001 | Control: No Routine Early NMB | Use of non-study NMB will be discouraged. |
| |
| Secondary | 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. | 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. | Posted | | Number | | participants | | 12 months after randomization | | | | ID | Title | Description |
|---|
| OG000 | Early Neuromuscular Blockade (NMB) | Patients will receive cisatracurium besylate for the first 48 hours of the trial. cisatracurium besylate: 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. | | OG001 | Control: No Routine Early NMB | Use of non-study NMB will be discouraged. |
| |