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NCT04136548 · ClinicalTrials.gov registry record · Phase 1
Analgesics in the Pre-hospital Setting: Implications on Hemorrhage Tolerance - Fentanyl
A Phase 1 study of Healthy, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 41
- Enrollment target
- 1
- Study location
NCT04136548: Completed Phase 1 study of Healthy, sponsored by University of Texas Southwestern Medical Center.
NCT04136548 is a Phase 1 study of Healthy that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 41 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04136548, a Phase 1 study of Healthy, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 41 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this project is to test how fentanyl, an analgesic currently employed in the pre-hospital setting by the US Army, alters the capacity to tolerate a hemorrhagic insult in humans.
Primary Outcome
Tolerance to a simulated hemorrhagic challenge will be assessed, for both the placebo and fentanyl limbs, by causing progressive central hypovolemia via lower-body negative pressure (LBNP). This progressive lower-body negative pressure challenge will be performed until the onset of syncopal symptoms (defined as: profound bradycardia, a precipitous drop in arterial blood pressure and accompanying narrowing of pulse pressure, a sustained systolic blood pressure less than 80 mmHg, and/or subjective
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Fentanyl
Study Locations (1)
Texas
- University of Texas Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2019-06-01 |
| Est. Completion | 2020-11-18 |
| Phase | Phase 1 |
What the finished NCT04136548 record still lists
NCT04136548 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04136548 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04136548 about?
NCT04136548 is a clinical study titled "Analgesics in the Pre-hospital Setting: Implications on Hemorrhage Tolerance - Fentanyl". The purpose of this project is to test how fentanyl, an analgesic currently employed in the pre-hospital setting by the US Army, alters the capacity to tolerate a hemorrhagic insult in humans.
What is the current status of trial NCT04136548?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2019-06-01. Estimated completion is 2020-11-18.
What conditions does trial NCT04136548 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT04136548?
The interventions under investigation include: Placebo (OTHER), Fentanyl (DRUG).
Who is sponsoring clinical trial NCT04136548?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04136548 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04136548's enrollment target sits among peer trials
41 536th of 1090 higher than 552 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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