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

NCT01293500 | Terminated DMC

• 1 other identifier: 1R21HD060171-01A2
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Inflammatory Response Syndrome

Keywords

SIRS; shock; sepsis; pediatric; inter-facility transport; specialized transport; NIRS monitoring

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Changes in cerebral and somatic oxygenation

  During Inter-facility Transport (Average)

Interventions

Goal-directed Therapeutic Protocol PROCEDURE

A 10 month period of data collection for transport patients with SIRS (Systemic Inflammatory Response Syndrome) will be followed by training and institution of a goal-directed resuscitation protocol. A second 10 month data collection period will then commence. Groups will be compared with respect to outcome measures at the end of the study. All subjects will be monitored with NIRS cerebral and somatic oximetry.

Eligibility Criteria

• Age: 1 Month - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Arkansas Children's Hospital Research Institute: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

Related Publications (1)

• 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.

  PMID: 25860203 DERIVED

MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome; Shock; Sepsis

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections

Study Officials

• Michael H Stroud, MD

  Arkansas Children's Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2010
• First Posted: February 10, 2011
• Study Start: October 1, 2010
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: October 2, 2025

Record last verified: 2016-05

Locations

US (1)