SIRS (Systemic Inflammatory Response Syndrome( Clinical Trial
— GRIPITOfficial title:
Goal-directed Resuscitative Interventions During Pediatric Inter-facility Transport (The GRIPIT Trial)
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.
| Status | Terminated |
| Enrollment | 230 |
| Est. completion date | November 2014 |
| Est. primary completion date | November 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 1 Month to 17 Years |
| Eligibility |
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 |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Arkansas Children's Hospital | Little rock | Arkansas |
| Lead Sponsor | Collaborator |
|---|---|
| Arkansas Children's Hospital Research Institute | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of Multiple Organ Dysfunction | Computed utilizing PELOD scores. | ICU Admission to ICU Discharge | No |
| Primary | Required ICU Interventions | Utilizing TISS-28 Scores | ICU Admission to ICU Discharge | No |
| Primary | Hospital Length of Stay | Subjects will be followed from hospital admission to hospital discharge. | Hospital Admission to Hospital Discharge | No |
| Secondary | Changes in cerebral and somatic oxygenation | Utilizing NIRS Technology | During Inter-facility Transport (Average) | No |