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Clinical Trials/NCT01293500
NCT01293500
Terminated
N/A

Goal-directed Resuscitative Interventions During Pediatric Inter-facility Transport (The GRIPIT Trial)

Arkansas Children's Hospital Research Institute1 site in 1 country230 target enrollmentOctober 1, 2010

Overview

Phase
N/A
Intervention
Not specified
Conditions
Not specified
Sponsor
Arkansas Children's Hospital Research Institute
Enrollment
230
Locations
1
Primary Endpoint
Incidence of Multiple Organ Dysfunction
Status
Terminated
Last Updated
7 months ago

Overview

Brief Summary

Recent advances in critical care medicine have dramatically improved morbidity and mortality of critical illness. Goal-directed therapy protocols have been instrumental in this change. Goal-directed therapy standardizes the rapid delivery of definitive care in illnesses such as SIRS (Systemic Inflammatory Response Syndrome) and head trauma. Although this treatment approach has been shown to improve clinical outcomes, it has not been widely adopted outside academic medical centers. Further improvement in outcomes of critical illness is likely if goal-directed therapy is utilized early in the course of care. To facilitate this early adoption, goal-directed therapeutic protocols should be developed and implemented by specialized pediatric transport teams. The investigators hypothesize that the institution of goal-directed therapy during pediatric interfacility transport will improve the outcomes of critically ill children.

The GRIPIT Trial (Goal-directed Resuscitative Interventions during Pediatric Inter-facility Transport) will compare outcomes of pediatric SIRS patients before and after the implementation of a goal-directed therapeutic protocol during transport. This will be the first test of goal-directed therapy in the transport environment. Data will be collected on pediatric SIRS patients transported by the Angel One Transport Team at Arkansas Children's Hospital before and after protocol implementation. Outcome measures will include length of hospital stay, length of intensive care unit (ICU) stay, incidence of multiple organ dysfunction syndrome (MODS), and required therapeutic interventions during ICU stay (TISS-28 scores). In addition, NIRS (Near-Infrared Spectroscopy) monitoring will be used as a cerebral and somatic oxygenation trend monitor, to determine its effectiveness as a resuscitation guide for pediatric SIRS during transport. NIRS trends are useful as a surrogate marker for systemic venous saturations, known to decrease with severe SIRS.

Registry
clinicaltrials.gov
Start Date
October 1, 2010
End Date
November 1, 2014
Last Updated
7 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Pediatric patients transported to Arkansas Children's Hospital by the Angel One Transport Team
  • Age Group: 1 month - 17 years
  • Systemic Inflammatory Response Syndrome (Age-specific SIRS criteria)

Exclusion Criteria

  • Known or suspected congenital heart disease
  • Known or suspected cardiomyopathy or myocarditis
  • Diabetic Ketoacidosis (DKA) as SIRS-inducing illness
  • Traumatic Brain Injury (TBI) as SIRS-inducing illness
  • Burn Injury as SIRS-inducing illness
  • Patients with known or suspected active hemorrhage

Outcomes

Primary Outcomes

Incidence of Multiple Organ Dysfunction

Time Frame: ICU Admission to ICU Discharge

Computed utilizing PELOD scores.

Required ICU Interventions

Time Frame: ICU Admission to ICU Discharge

Utilizing TISS-28 Scores

Hospital Length of Stay

Time Frame: Hospital Admission to Hospital Discharge

Subjects will be followed from hospital admission to hospital discharge.

Secondary Outcomes

  • Changes in cerebral and somatic oxygenation(During Inter-facility Transport (Average))

Study Sites (1)

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