Trial · NCT01739933
The MENDS2 Study, Maximizing the Efficacy of Sedation and Reducing Neurological Dysfunction and Mortality in Septic Patients With Acute Respiratory Failure
NCT01739933, Phase 3, Completed, Vanderbilt University Medical Center; results first posted 2021-06-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The MENDS2 Study, Maximizing the Efficacy of Sedation and Reducing Neurological Dysfunction and Mortality in Septic Patients With Acute Respiratory Failure. Trials, record NCT01739933. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01739933
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The MENDS2 Study, Maximizing the Efficacy of Sedation and Reducing Neurological Dysfunction and Mortality in Septic Patients With Acute Respiratory Failure
- NCT number
- NCT01739933
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 438 participants, actual
- Lead sponsor
- Vanderbilt University Medical Center
- Conditions
- Sepsis, Delirium, Impaired Cognition
- Interventions
- Dexmedetomidine, Propofol
- First posted
- 2012-12-04
- Last updated
- 2021-06-07
- Results first posted
- 2021-06-07
- Limitations and caveats
- Sample size readjusted to 420 with approval from NIH and DSMB
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Delirium/Coma Free Days (DCFDs) | 14 days | The analysis of DCFDs will be conducted using Intention-to-Treat (ITT) population, defined as all patients who were randomized and received study drug. We chose a 14 day evaluation period for delirium, because it represents the best balance of gaining valuable clinical information, while maximizing resource utilization, given the average study drug infusion to be 7 days and maximum duration to be 14 days. Thus our follow-up period will cover 7 additional days of delirium monitoring after the study drug is stopped in the majority of our patients. |
| Secondary | Ventilator-free Days (VFDs) | 28 Days | Ventilator-free days (VFDs), i.e., days alive and free of mechanical ventilation (MV) at 28 days. This endpoint has been used by the National Heart, Lung, and Blood Institute (NHLBI) ARDSNet in numerous critical care trials examining ICU populations. |
| Secondary | Death at 90 Days | 1 through 90 days | That sedation of mechanically ventilated severely septic patients with an alpha2 agonist (dexmedetomidine) rather than a GABAergic agent (propofol) will improve 90-day survival of ICU patients. |
| Secondary | Cognitive Function Utilizing the Telephone Interview for Cognitive Status Total (TICS-T) | 6 months after randomization | The Telephone Interview for Cognitive Status is a standardized test of cognitive functioning that monitors changes in cognitive functioning over time. The TICS-T consists 11 items including wordlist memory, orientation, attention, repetition, conceptual knowledge and nonverbal praxis. Age-adjusted total scores on the TICS-T range from 0 to 100 with a mean of 50+/-10; lower scores indicate worse cognition, and a score of 35 or less indicates cognitive impairment. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Delirium/Coma Free Days (DCFDs) | 14 days | days | MEDIAN | |
| SECONDARY | Ventilator-free Days (VFDs) | 28 Days | days | MEDIAN | |
| SECONDARY | Death at 90 Days | 1 through 90 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Cognitive Function Utilizing the Telephone Interview for Cognitive Status Total (TICS-T) | 6 months after randomization | score on a scale | MEDIAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Delirium/Coma Free Days (DCFDs) | Dexmedetomidine | 8 | Inter-Quartile Range 1 to 12.8 | days | |
| Delirium/Coma Free Days (DCFDs) | Propofol | 7.5 | Inter-Quartile Range 1.8 to 11.2 | days | |
| Ventilator-free Days (VFDs) | Dexmedetomidine | 20.9 | Inter-Quartile Range 0 to 26.1 | days | |
| Ventilator-free Days (VFDs) | Propofol | 19.9 | Inter-Quartile Range 4.2 to 24.9 | days | |
| Death at 90 Days | Dexmedetomidine | 81 | Participants | ||
| Death at 90 Days | Propofol | 82 | Participants | ||
| Cognitive Function Utilizing the Telephone Interview for Cognitive Status Total (TICS-T) | Dexmedetomidine | 39 | Inter-Quartile Range 28 to 48 | score on a scale | |
| Cognitive Function Utilizing the Telephone Interview for Cognitive Status Total (TICS-T) | Propofol | 38 | Inter-Quartile Range 30 to 46 | score on a scale |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dexmedetomidine | 214 | |
| Overall Study | STARTED | Propofol | 208 | |
| Overall Study | Discharged From Hospital and Eligible for Follow-up | Dexmedetomidine | 140 | |
| Overall Study | Discharged From Hospital and Eligible for Follow-up | Propofol | 147 | |
| Overall Study | COMPLETED | Dexmedetomidine | 108 | |
| Overall Study | COMPLETED | Propofol | 101 | |
| Overall Study | NOT COMPLETED | Dexmedetomidine | 106 | |
| Overall Study | NOT COMPLETED | Propofol | 107 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dexmedetomidine | 89 | 214 |
| Total, all-cause mortality | Propofol | 86 | 208 |
| Total, other adverse events | Dexmedetomidine | 0 | 214 |
| Total, other adverse events | Propofol | 0 | 208 |
| Total, serious adverse events | Dexmedetomidine | 0 | 214 |
| Total, serious adverse events | Propofol | 0 | 208 |
Source ClinicalTrials.gov
Papers2
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 |
|---|---|---|---|---|---|
| R01HL111111 | Altering Sedation Paradigms to Improve Brain Injury and Survival in Severe Sepsis | PANDHARIPANDE, PRATIK | VANDERBILT UNIVERSITY MEDICAL CENTER | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2012 to 2017 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dexmedetomidine vs Propofol: Death at 90 Days | Trial comparisons |
| Dexmedetomidine vs Propofol: deaths from any cause | Trial comparisons |
| Dexmedetomidine vs Propofol: 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/NCT01739933
GET https://conductscience.org/api/trials/v1/NCT01739933/registered