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

Not Applicable

Terminated

• Conditions: SIRS (Systemic Inflammatory Response Syndrome(

• Registration Number: NCT01293500
• Lead Sponsor: Arkansas Children's Hospital Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-22
• Study First Submitted QC: 2011-02-09
• Study First Posted: 2011-02-10
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-03
• Last Update Posted: 2016-05-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 230

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Incidence of Multiple Organ Dysfunction	ICU Admission to ICU Discharge	Computed utilizing PELOD scores.
Required ICU Interventions	ICU Admission to ICU Discharge	Utilizing TISS-28 Scores
Hospital Length of Stay	Hospital Admission to Hospital Discharge	Subjects will be followed from hospital admission to hospital discharge.

Secondary Outcome Measures

Name	Time	Method
Changes in cerebral and somatic oxygenation	During Inter-facility Transport (Average)	Utilizing NIRS Technology

Trial Locations

Locations (1)

Arkansas Children's Hospital; 🇺🇸 Little rock, Arkansas, United States