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The MENDS2 Study, Maximizing the Efficacy of Sedation and Reducing Neurological Dysfunction and Mortality in Septic Patients With Acute Respiratory Failure
NCT01739933 · View on ClinicalTrials.gov ↗
Study Summary
Ventilated ICU patients frequently have sepsis and the majority have delirium, a form of brain dysfunction that is an independent predictor of increased risk of dying, length of stay, costs, and prolonged cognitive impairment in survivors. Universally prescribed sedative medications-the GABA-ergic benzodiazepines-worsen this brain organ dysfunction. The available alternative sedation regimens, the shorter acting GABA-ergic propofol, and the alpha2 agonist, dexmedetomidine, have both been shown to be superior to benzodiazepines, and yet are different with regard to their effects on innate immunity, bacterial clearance, apoptosis, cognition and delirium. The MENDS2 study will compare propofol and dexmedetomidine, and determine the best sedative medication to reduce delirium and improve survival and long-term brain function in our most vulnerable patients- the ventilated septic patient.
Conditions Studied
Interventions
- DRUG Dexmedetomidine
- DRUG Propofol
Study Locations (11)
Texas
- Texas Health Harris Fort Worth — Fort Worth
- Baylor College of Medicine — Houston
- Houston Methodist Hospital — Houston
- University of Texas Health Science Center at San Antonio — San Antonio
Massachusetts
- Tufts Medical Center — Boston
- Baystate Medical Center — Springfield
California
- University of California, San Francisco — San Francisco
Louisiana
- Baton Rouge General Medical Center and Our Lady of The Lakes Regional Medical Center — Baton Rouge
North Carolina
- Mission Hospital — Asheville
Tennessee
- Vanderbilt University Medical Center — Nashville
Wisconsin
- University of Wisconsin — Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 438 participants |
| Start Date | 2013-05-15 |
| Est. Completion | 2019-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01739933
The ClinicalTrials.gov registry entry for NCT01739933 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 438 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 695 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Sepsis appearing as the primary indexed condition, and to 2 interventions — of which Dexmedetomidine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01739933 reports 11 study locations spanning 7 distinct geographic areas — top geographies include Texas, Massachusetts, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01739933 about?
NCT01739933 is a clinical study titled "The MENDS2 Study, Maximizing the Efficacy of Sedation and Reducing Neurological Dysfunction and Mortality in Septic Patients With Acute Respiratory Failure". Ventilated ICU patients frequently have sepsis and the majority have delirium, a form of brain dysfunction that is an independent predictor of increased risk of dying, length of stay, costs, and prolonged cognitive impairment in survivors. Universally prescribed sedative medications-the GABA-ergic b...
What is the current status of trial NCT01739933?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 438 participants. The study started on 2013-05-15. Estimated completion is 2019-07.
What conditions does trial NCT01739933 study?
This clinical trial studies the following conditions: Sepsis, Delirium, Impaired Cognition. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01739933?
The interventions under investigation include: Dexmedetomidine (DRUG), Propofol (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01739933?
This trial is sponsored by Vanderbilt University Medical Center, which has 695 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01739933 being conducted?
This trial has 11 study locations across California, Louisiana, Massachusetts, North Carolina, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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