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NCT00795366 · ClinicalTrials.gov registry record · NA
Vasopressin Versus Catecholamines for Cerebral Perfusion Pressure Control in Brain Injured Trauma Patients
A NA study, sponsored by University of Miami.
- Completed
- Registry status
- NA
- Development phase
- 96
- Enrollment target
NCT00795366: Completed NA study, sponsored by University of Miami.
NCT00795366 is a NA study that has completed, run by University of Miami. The registered enrollment target is 96 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00795366, a NA study, has completed, sponsored by University of Miami.
- COMPLETED
- Registry status
- NA
- Development phase
- 96 participants
- Enrollment target
Study Summary
Traumatic brain injury (TBI) is among the leading causes of trauma death and disability in both civilian and military populations. The damage that occurs at the instant of trauma cannot be modified; the secondary injuries that occur afterward are the impediments to recovery and can be influenced by the physician. Cerebral ischemia is the most important secondary event that determines outcome following TBI. To minimize ischemic episodes once the patient has arrived at the hospital, most treatments are aimed at optimizing cerebral perfusion pressure (CPP). The cornerstones of these treatments include mannitol, to reduce intracranial pressure (ICP), and catecholamines, such as phenylephrine (PE), to increase mean arterial pressure (MAP), but these agents have undesired side effects. Nevertheless, once they lose potency, there are few alternatives. The main objective of this proposal to develop a new therapeutic option for CPP management in TBI patients using arginine vasopressin (AVP). AVP is the endogenous anti-diuretic hormone. It is FDA-approved for use in the diagnosis and treatment of diabetes insipidus, for the prevention and treatment of post-operative abdominal distention, and in abdominal radiography to dispel interfering gas shadows. It has been used off-label for several other conditions. There is minimal information on its therapeutic potential after TBI. The investigators have demonstrated that AVP during fluid resuscitation rapidly restored hemodynamics, CPP, and improves acute survival in a clinically-relevant model of TBI. The investigators observed similar short term benefits after chest and liver trauma. Nevertheless, AVP has actions that could mask any short term benefit. The investigators have already defined risks and benefits of AVP therapy, relative to PE, in four different clinically-relevant laboratory model. The investigators now plan to evaluate this new therapy relative to the current evidence-based guideline for CPP management in TBI patie
Primary Outcome
The number of hours that participants remained with intracranial pressure above 20 mmHg
Interventions
- DRUG arginine vasopressin
- DRUG Standard catecholamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2008-09 |
| Est. Completion | 2014-09 |
| Phase | NA |
What the finished NCT00795366 record still lists
NCT00795366 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which arginine vasopressin is the first listed.
NCT00795366 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00795366 about?
NCT00795366 is a clinical study titled "Vasopressin Versus Catecholamines for Cerebral Perfusion Pressure Control in Brain Injured Trauma Patients". Traumatic brain injury (TBI) is among the leading causes of trauma death and disability in both civilian and military populations. The damage that occurs at the instant of trauma cannot be modified; the secondary injuries that occur afterward are the impediments to recovery and can be influenced by ...
What is the current status of trial NCT00795366?
This trial is currently completed. It is a NA study. The enrollment target is 96 participants. The study started on 2008-09. Estimated completion is 2014-09.
What interventions are being tested in trial NCT00795366?
The interventions under investigation include: arginine vasopressin (DRUG), Standard catecholamine (DRUG).
Who is sponsoring clinical trial NCT00795366?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00795366's enrollment target sits among peer trials
96 925th of 2000 higher than 1,070 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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