Hypertonic Saline With Dextran for Treating Hypovolemic Shock and Severe Brain Injury

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00113685
First received: June 9, 2005
Last updated: January 26, 2010
Last verified: April 2007
  Purpose

The purpose of this study is to evaluate the clinical outcome of patients following blunt traumatic injury with hypovolemic shock, who receive either lactated ringer's solution or hypertonic saline with dextran (HSD) resuscitation; also, to focus specifically on neurologic outcome in patients with brain injury and on the effect of HSD resuscitation on inflammatory cell responsiveness.


Condition Intervention
Respiratory Distress Syndrome, Adult
Head Injuries, Closed
Shock
Shock, Traumatic
Drug: Hypertonic Saline-Dextran Solution
Drug: Lactated Ringer's Solution

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effect of Hypertonic Resuscitation for Blunt Trauma

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Adult respiratory distress syndrome symptoms (measured 28 days post-injury)

Secondary Outcome Measures:
  • Multiple organ failure syndrome
  • 28 day mortality
  • Nosocomial infections
  • Duration of hospital and ICU stay
  • Duration of mechanical ventilation
  • Neurologic outcome for patients with traumatic brain injury based on the Glasgow Outcome Score and Disability Rating Score (measured at 6 and 12 months post-injury)

Estimated Enrollment: 209
Study Start Date: April 2003
Estimated Study Completion Date: March 2007
Detailed Description:

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, a type of shock in which the heart is unable to supply enough blood to the body, and the resulting 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 pre-hospital environment. Previous studies have suggested that an alternative resuscitation fluid, HSD, may reduce mortality in these patients; but these studies 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 to receive either 250 cc of HSD or 250 cc of isotonic solution (lactated ringer's solution). Lactated ringer's solution is the current standard of care with which the ambulances and helicopters will be supplied. All bags of study solution will be prepared by the Harborview Medical Center pharmacy.

DESIGN NARRATIVE:

This 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 either 7.5% hypertonic saline/6% dextran (HSD) followed by lactated ringer's solution or lactated ringer's solution alone. It is hypothesized 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 typically induced by this response. Furthermore, the study will 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 HSD intervention. The specific aims for this study include the following: Aim 1: To determine the impact of pre-hospital administration of HSD on the development of organ failure following blunt traumatic injury with hypovolemic shock. Aim 2: To determine the impact of pre-hospital administration of HSD on the neurologic outcome following brain injury for patients in hypovolemic shock. Aim 3a: To determine the effect of pre-hospital administration of HSD on the activation of circulating neutrophils and monocytes. Aim 3b: To determine the effect of pre-hospital administration of HSD on the activation of T lymphocytes. The study builds upon previous research that has demonstrated the safety and practicality of this resuscitation strategy in the pre-hospital 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 for determining the role of this resuscitation approach in such critically injured patients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Recent blunt trauma
  • Of adult size if age is unknown
  • Pre-hospital systolic bloood pressure 90 mm Hg or less
  • Altered mental status
  • Transported directly to Harborview Medical Center from the injury event

Exclusion Criteria:

  • Ongoing CPR
  • Transferred from outside hospitals
  • Pregnant or suspected pregnancy
  • Presence of injuries from penetrating trauma
  • Receiving more than 2000 cc of crystaloid prior to study fluid administration
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00113685

Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98104-2499
Sponsors and Collaborators
Investigators
Study Chair: Eileen Bulger University of Washington
  More Information

Additional Information:
No publications provided by National Heart, Lung, and Blood Institute (NHLBI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00113685     History of Changes
Other Study ID Numbers: 178, R01 HL73233
Study First Received: June 9, 2005
Last Updated: January 26, 2010
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Craniocerebral Trauma
Shock
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Shock, Traumatic
Head Injuries, Closed
Wounds and Injuries
Trauma, Nervous System
Nervous System Diseases
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Wounds, Nonpenetrating
Dextrans
Pharmaceutical Solutions
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Plasma Substitutes
Blood Substitutes

ClinicalTrials.gov processed this record on August 20, 2014