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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 is a NA study that has completed, run by University of Miami. The registered enrollment target is 96 participants.

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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

Interventions

  • DRUG arginine vasopressin
  • DRUG Standard catecholamine

Trial Details

FieldValue
Enrollment Target 96 participants
Start Date 2008-09
Est. Completion 2014-09
Phase NA

Sponsor

University of Miami

721 total trials

What the Registry Record Tells You About NCT00795366

The ClinicalTrials.gov registry entry for NCT00795366 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Miami, which has 721 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which arginine vasopressin is the first listed.

NCT00795366 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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