Clinical trial NCT01293500: Goal-directed Resuscitative Interventions During Pediatric Inter-facility Transport (The GRIPIT Trial)
Official title: Goal-directed Resuscitative Interventions During Pediatric Inter-facility Transport (The GRIPIT Trial)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: SIRS (Systemic Inflammatory Response Syndrome(
Keywords: SIRS
shock
sepsis
pediatric
inter-facility transport
specialized transport
NIRS monitoring
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2011-02-10
Enrollment: 230
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Incidence of Multiple Organ Dysfunction
timeFrame: ICU Admission to ICU Discharge
measure: Required ICU Interventions
timeFrame: ICU Admission to ICU Discharge
measure: Hospital Length of Stay
timeFrame: Hospital Admission to Hospital Discharge
Secondary outcomes:
measure: Changes in cerebral and somatic oxygenation
timeFrame: During Inter-facility Transport (Average)
Other outcomes:
Locations:
city: Little rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
Study officials:
affiliation: Arkansas Children's Hospital Research Institute
name: Michael H Stroud, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.