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NCT01611935 · ClinicalTrials.gov registry record · Phase 2
AVERT Shock: Arginine Vasopressin During the Early Resuscitation of Traumatic Shock
A Phase 2 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 2
- Development phase
- 101
- Enrollment target
NCT01611935: Completed Phase 2 study, sponsored by University of Pennsylvania.
NCT01611935 is a Phase 2 study that has completed, run by University of Pennsylvania. The registered enrollment target is 101 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01611935, a Phase 2 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 101 participants
- Enrollment target
Study Summary
Trauma patients, who are transfused with multiple blood products to treat shock due to blood loss, frequently develop inappropriately low vasopressin levels. Vasopressin is a hormone necessary to maintain an adequate blood pressure and low levels have been associated with the need for increased transfusions, vasopressors and additional morbidity. Vasopressin is routinely used in the ICU to treat septic shock and other disease processes resulting in decreased vasopressin levels and low blood pressure. This study will investigate the potential benefit of early vasopressin supplementation during the resuscitation of trauma patients and the applicability of using copeptin as a vasopressin biomarker. Trauma patients who receive 6 or more units of blood product within 12 hours of arrival will be randomized to receive a vasopressin bolus plus infusion or a similar volume of a placebo (normal saline) for 48 hours. Serial blood samples will be taken for 5 days post-injury. Clinical and demographic data will be recorded prospectively.
Interventions
- DRUG Vasopressin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2013-05-01 |
| Est. Completion | 2016-09-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01611935
The ClinicalTrials.gov registry entry for NCT01611935 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 101 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Vasopressin is the first listed.
NCT01611935 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01611935 about?
NCT01611935 is a clinical study titled "AVERT Shock: Arginine Vasopressin During the Early Resuscitation of Traumatic Shock". Trauma patients, who are transfused with multiple blood products to treat shock due to blood loss, frequently develop inappropriately low vasopressin levels. Vasopressin is a hormone necessary to maintain an adequate blood pressure and low levels have been associated with the need for increased tran...
What is the current status of trial NCT01611935?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 101 participants. The study started on 2013-05-01. Estimated completion is 2016-09-06.
What interventions are being tested in trial NCT01611935?
The interventions under investigation include: Vasopressin (DRUG).
Who is sponsoring clinical trial NCT01611935?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
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