Trial · NCT02508649
Outcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Vasopressor- and Mechanical Ventilator-free Days (PVFDs) | Up to Day 30 | The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed. The primary comparison to determine statistical and clinical significance was between all subjects in all selepressin arms (pooled together and treated as a single arm) and all subjects in the placebo arm, to control Type 1 error. | days | LEAST_SQUARES_MEAN |
| SECONDARY | All-cause Mortality | At Day 90 | The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed. The primary comparison to determine statistical and clinical significance was between all subjects in all selepressin arms (pooled together and treated as a single arm) and all subjects in the placebo arm, to control Type 1 error. | percentage of subjects | NUMBER |
| SECONDARY | Renal Replacement Therapy (RRT)-Free Days | Up to Day 30 | The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed. The primary comparison to determine statistical and clinical significance was between all subjects in all selepressin arms (pooled together and treated as a single arm) and all subjects in the placebo arm, to control Type 1 error. | days | LEAST_SQUARES_MEAN |
| SECONDARY | Intensive Care Unit (ICU)-Free Days | Up to Day 30 | The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed. The primary comparison to determine statistical and clinical significance was between all subjects in all selepressin arms (pooled together and treated as a single arm) and all subjects in the placebo arm, to control Type 1 error. | days | LEAST_SQUARES_MEAN |
| SECONDARY | Vasopressor-free Days up to Day 30 | Up to Day 30 | The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed. | days | MEDIAN |
| SECONDARY | Mechanical Ventilator-free Days up to Day 30 | Up to Day 30 | The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed. | days | MEDIAN |
| SECONDARY | Duration of Septic Shock (i.e. Vasopressor Use) up to Day 30 | Up to Day 30 | The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed. | days | MEDIAN |
| SECONDARY | Duration of Mechanical Ventilation up to Day 30 | Up to Day 30 | The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed. | days | MEDIAN |
| SECONDARY | The Percentage of Subjects With RRT up to Day 30 (Counting Subjects Who Died as on RRT and Excluding Subjects on RRT for Chronic Renal Failure at the Time of Randomization) | Up to Day 30 | The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of RRT up to Day 90 (Excluding Subjects on RRT for Chronic Failure at the Time of Randomization) | Up to Day 90 | The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed. | days | MEAN |
| SECONDARY | Overall and Individual Organ (Cardiovascular, Respiratory, Renal, Hepatic, Coagulation) Scores Using a Modified Version of the SOFA up to Day 7 or Until ICU Discharge | Days 1, 3, and 7 or discharge from ICU | The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed. The primary comparison to determine statistical and clinical significance was between all subjects in all selepressin arms (pooled together and treated as a single arm) and all subjects in the placebo arm, to control Type 1 error. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Subjects With New Organ Dysfunction and New Organ Failure (Based on the SOFA Score) up to Day 7 and Day 30 | Up to Day 7 and Day 30 | The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed. The primary comparison to determine statistical and clinical significance was between all subjects in all selepressin arms (pooled together and treated as a single arm) and all subjects in the placebo arm, to control Type 1 error. | percentage of subjects | NUMBER |
| SECONDARY | ICU Length of Stay up to Day 30 | Up to Day 30 | The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed. | days | MEDIAN |
| SECONDARY | All-cause Mortality (Defined as the Percentage of Subjects That Have Died, Regardless of Cause) at Day 30 and Day 180 | At Day 30 and Day 180 | The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Daily Fluid Balance Until ICU Discharge (for a Maximum of 7 Days) | Baseline and Days 1-7 | The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed. | mL/h | MEAN |
| SECONDARY | Cumulative Fluid Balance Until ICU Discharge (for a Maximum of 7 Days) | Baseline and Days 1-7 | The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed. | mL | MEAN |
| SECONDARY | Daily Urine Output Until ICU Discharge (for a Maximum of 7 Days) | Baseline and Days 1-7 | The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed. | mL/h | MEAN |
| SECONDARY | Cumulative Urine Output Until ICU Discharge (for a Maximum of 7 Days) | Baseline and Days 1-7 | The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed. | mL | MEAN |
| SECONDARY | Utility, Based on the EuroQol Group's 5-dimension 5-level (EQ-5D-5L) Questionnaire, up to Day 180 | Baseline and Days 30, 60, 90 and 180 | The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed. | score on a scale | MEAN |
| SECONDARY | Utility, Based on the EuroQol Group's 5-dimension 5-level (EQ-5D-5L) Questionnaire, up to Day 180 | Days 30, 60, 90 and 180 | The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed. | Quality-adjusted life-year | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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