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Status:

COMPLETED

Critical Care Excellence in Sepsis and Trauma

Lead Sponsor:

Medical University of South Carolina

Collaborating Sponsors:

National Institute on Minority Health and Health Disparities (NIMHD)

Conditions:

Sepsis

Trauma

Eligibility:

All Genders

18+ years

Brief Summary

The care of patients with sepsis and trauma requires the delivery of appropriate definitive care in the early stages of the illness. Hospitals with limited resources, those in rural and underserved ar...

Detailed Description

The impetus for CREST derives from the observation that rural patients are unlikely to acquire on-site access to appropriate specialist care for high stakes, high acuity, crisis-mode conditions such a...

Eligibility Criteria

Inclusion

  • Sepsis study patients are adult patients presenting to the rural hospital's EDs that meet the screening criteria for sepsis and two of four SIRS criteria.
  • The screening criteria for possible sepsis are:
  • known or suspected infection AND EITHER
  • systolic blood pressure \< 90mmHg after fluid challenge of 30mL/kg over 30 minutes OR
  • lactate \> 4mmol/L
  • The screening criteria for possible SIRS are:
  • abnormal core body temperature (\<36.5 C or \> 38 C)
  • heart rate \> 90 bpm
  • respiratory insufficiency (respiratory rate \> 20 breaths/min or PaCO2 \< 32 mmHg or mechanical ventilation)
  • abnormal white blood count (\>12,000/cumm or \< 4000/cumm)
  • Trauma study patients are adult patients presenting to the rural hospital's EDs with blunt or penetrating injury and one or more of the following criteria:
  • Respiratory insufficiency and/or intubation
  • Glasgow coma scale \< 8 with mechanism attributed to trauma
  • Systolic blood pressure of \<90mmHg
  • Paralysis
  • Penetrating injury to the head/neck/torso
  • Crush to torso/upper thighs
  • Major amputations
  • Loss of consciousness \> 5 minutes
  • Maxillo-facial trauma
  • Significant subcutaneous air
  • Evidence of pelvic instability
  • Two or more long bone deformities
  • Major lacerations involving fascia
  • Ejection from vehicle
  • Pedestrian struck \> 15 mph
  • Motorcycle Crash \> 25 mph
  • Motor Vehicle Collision \> 35 mph
  • Documented falls \> 20 feet or 2 stories

Exclusion

  • The exclusion criteria for septic patients are:
  • Age \< 18 years
  • The exclusion criteria for trauma patients are:
  • Age \< 18 years
  • Burn injury of greater than 10% total body surface area
  • Traumatic asphyxiation
  • Lightning strike/electrical shock
  • Patients undergoing cardiopulmonary resuscitation (CPR) on arrival

Key Trial Info

Start Date :

September 1 2009

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

March 1 2012

Estimated Enrollment :

26 Patients enrolled

Trial Details

Trial ID

NCT01426711

Start Date

September 1 2009

End Date

March 1 2012

Last Update

April 30 2018

Active Locations (5)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 2 (5 locations)

1

Bamberg County Hospital

Bamberg, South Carolina, United States, 29003

2

Barnwell County Hospital

Barnwell, South Carolina, United States, 29812

3

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

4

Williamsburg Regional Medical Center

Kingstree, South Carolina, United States, 29556