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

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.

Study Overview

• Status: Terminated
• Conditions: SIRS (Systemic Inflammatory Response Syndrome(
• Intervention / Treatment: Procedure: Goal-directed Therapeutic Protocol

• Study Type: Interventional
• Enrollment (Actual): 230
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little rock, Arkansas, United States, 72202
      • Arkansas Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in cerebral and somatic oxygenation	Utilizing NIRS Technology	During Inter-facility Transport (Average)

Collaborators and Investigators

• Sponsor: Arkansas Children's Hospital Research Institute
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Michael H Stroud, MD, Arkansas Children's Hospital Research Institute

Publications and helpful links

General Publications

• Stroud MH, Sanders RC Jr, Moss MM, Sullivan JE, Prodhan P, Melguizo-Castro M, Nick T. Goal-Directed Resuscitative Interventions During Pediatric Interfacility Transport. Crit Care Med. 2015 Aug;43(8):1692-8. doi: 10.1097/CCM.0000000000001021.

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: October 22, 2010
• First Submitted That Met QC Criteria: February 9, 2011
• First Posted (Estimate): February 10, 2011

Study Record Updates

• Last Update Posted (Estimate): May 5, 2016
• Last Update Submitted That Met QC Criteria: May 3, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: pediatric; shock; sepsis; SIRS; NIRS monitoring; inter-facility transport; specialized transport
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Shock; Systemic Inflammatory Response Syndrome
• Other Study ID Numbers: 1R21HD060171-01A2 (U.S. NIH Grant/Contract)