Low Dose Vasopressin in Traumatic Shock

The University of Texas System (UT)

Status and phase

Terminated

Early Phase 1

Conditions

Shock, Traumatic

Injuries

Treatments

Drug: normal saline control

Drug: vasopressin

Study type

Interventional

Funder types

Other

Identifiers

NCT00420407

056-1502-090

Details and patient eligibility

About

Hypothesis: We hypothesize that resuscitation regimens which minimize the total volume of resuscitation fluid, while restoring organ perfusion, will lead to lower morbidity and mortality in critically ill patients following trauma.

Enrollment

81 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

To be eligible for enrollment in the study, a patient must meet all of the follow criteria at assessment:

Patient is a male or female patient presumed to be at least 18 years of age;
Patient has a systolic blood pressure < 90 mmHg;
Patient has clinical evidence of acute traumatic injury;
Infusion of study drug must start within one hour following SBP (systolic blood pressure) < 90 mmHg

Exclusion criteria

A patient meeting any one of the following criteria at hospital assessment is not eligible for enrollment:

Patient is admitted to one of the study hospitals' Emergency Department greater than six hours after injury;
Patient has received greater than 4 liters fluid since time of injury;
Patient is enrolled in another shock trial;
Patient is asystolic or requires CPR (cardiopulmonary resucitation) prior to randomization;
Female patient is pregnant by report or suspicion;
Patient has known "Do Not Resuscitate" orders or visible/identifiable method of objection to participation (e.g., exclusion bracelet);