To evaluate the clinical outcome of patients following blunt traumatic injury with hypovolemic shock, who receive lactated Ringers (LR) vs. hypertonic saline with dextran (HSD) resuscitation. Also, to focus specifically on neurologic outcome in the subset of patients with brain injury and on the effect of HSD resuscitation on the responsiveness of inflammatory cells.

Condition	Intervention
Acute Respiratory Distress Syndrome Head Injuries, Closed Shock Shock, Traumatic	Drug: Hypertonic saline-dextran solution  Drug: Ringer''''s solution

Further Study Details: 

BACKGROUND: Trauma is the leading cause of death among Americans between the ages of 1 and 35 years. The majority of these deaths result from hypovolemic shock and severe brain injury. Patients in hypovolemic shock develop a state of systemic tissue ischemia with a subsequent reperfusion injury at the time of fluid resuscitation. Conventional resuscitation of these patients involves the intravenous administration of a large volume of isotonic or slightly hypotonic (lactated ringers) solutions beginning in the prehospital environment. Previous studies have suggested that an alternative resuscitation fluid, hypertonic saline with dextran (HSD) may reduce mortality in these patients; but these have not been conclusive. Furthermore, HSD may have specific advantages in the brain-injured patient, as it may aid in the rapid restoration of cerebral perfusion, prevent extravascular fluid sequestration, and thus, limit secondary brain injury. In addition, recent studies have demonstrated that hypertonicity significantly alters the activation of inflammatory cells, which may result in a reduction in subsequent organ injury following whole body ischemia/reperfusion and ultimately decrease nosocomial infection rates. Blunt trauma victims with low blood pressures will be identified by pre-hospital providers (paramedics and flight nurses) and randomized either to receive 250 cc HSD or 250 cc of isotonic solution (lactated ringers). Lactated ringers is the current standard of care the ambulances and helicopters will be supplied with the IV bags from the pharmacy. All bags of study solution will be prepared by the Harborview Medical Center pharmacy.

DESIGN NARRATIVE: The randomized clinical trial seeks to evaluate the clinical outcome and inflammatory cell function of patients in shock following blunt traumatic injury who are randomized to receive 7.5% hypertonic saline/6% dextran (HSD) followed by lactated Ringer''''s versus lactated Ringer''''s alone. The investigators hypothesize that HSD resuscitation will inhibit the initial excessive systemic activation of the inflammatory response, which will translate into a reduction in the incidence of organ dysfunction induced by this response. Furthermore, they seek to evaluate the impact of HSD resuscitation on recovery following traumatic brain injury, as previous studies suggest that this subgroup has the greatest survival advantage from this intervention. The specific aims for this study include: Aim 1: To determine the impact of pre-hospital administration of hypertonic saline/dextran on the development of organ failure following blunt traumatic injury with hypovolemic shock. Aim 2: To determine the impact of prehospital administration of hypertonic saline/dextran on the neurologic outcome following brain injury" for patients in hypovolemic shock. Aim 3a: To determine the effect of prehospital administration of hypertonic saline/dextran on the activation of circulating neutrophils and monocytes. Aim 3b: To determine the effect of prehospital administration of hypertonic saline/dextran on the activation of T lymphocytes. The study builds upon previous research which has demonstrated the safety and practicality of this resuscitation strategy in the prehospital environment. A more detailed understanding of the immuno-inflammatory effects of hypertonicity for all patients and the long-term neurologic outcome for patients with brain injury is critical to determining the role of this resuscitation approach in these critically injured patients.

This will be a randomized study. There is a 50-50 chance, similar to flipping a coin, that a blunt trauma victim will receive HSD or the standard lactated ringers. Neither the victim nor the physician or paramedic will know whether the HSD or the lactated ringers was given. Randomization is necessary to assure that research findings do not occur from bias or chance

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

The patient must be at least 18 years old. Must have sustained a blunt trauma in the pre-hospital setting. Have hypovolemic shock defined as a systolic blood pressure less than 90mmHg Have an altered mental status (be confused or unconscious) The participant must be transported directly to Harborview Medical Center either by ambulance or helicopter.

Please refer to this study by ClinicalTrials.gov identifier  NCT00113685

Washington
      University of Washington, Seattle,  Washington,  98104-2499,  United States; Recruiting

Study chairs or principal investigators

Eileen Bulger,  University of Washington   

Study ID Numbers:  178
Record last reviewed:  June 2005
Last Updated:  June 30, 2005
Record first received:  June 9, 2005
ClinicalTrials.gov Identifier:  NCT00113685
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-07-05