drugset / Trial / NCT01411852

Field Trial of Hypotensive Versus Standard Resuscitation for Hemorrhagic Shock After Trauma

NCT01411852

RandomizedParallel-groupSingle-blindTreatment

Summary

Primary Aim: To determine the feasibility and safety of hypotensive resuscitation for the early treatment of patients with traumatic shock compared to standard fluid resuscitation. Primary Hypotheses: The null hypothesis regarding feasibility is that hypotensive resuscitation will result in the same volume of early crystalloid (normal saline) fluid administration compared to standard crystalloid resuscitation. The null hypothesis regarding safety is that hypotensive resuscitation will result in the same percent of patients surviving to 24 hours after 911 call received at dispatch compared to standard fluid resuscitation. Early resuscitation is defined as all fluid given until 2 hours after arrival in the Emergency Department or until hemorrhage control is achieved in the hospital, whichever occurs earlier.

Timeline

Start
2012-03
Primary completion
2013-04
Completion
2013-04

Drugs

EvaluationDrugModalityDoseRoute
Subject sodium chloride Unknown 250 ml Intravenous
Subject sodium chloride Unknown 2000 ml Intravenous

Indications