Goal-directed Resuscitative Interventions During Pediatric Inter-facility Transport (The GRIPIT Trial)
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
SIRS (Systemic Inflammatory Response Syndrome( |
Procedure: Goal-directed Therapeutic Protocol |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Goal-directed Resuscitative Interventions During Pediatric Inter-facility Transport (The GRIPIT Trial) |
- Incidence of Multiple Organ Dysfunction [ Time Frame: ICU Admission to ICU Discharge ] [ Designated as safety issue: No ]Computed utilizing PELOD scores.
- Required ICU Interventions [ Time Frame: ICU Admission to ICU Discharge ] [ Designated as safety issue: No ]Utilizing TISS-28 Scores
- Hospital Length of Stay [ Time Frame: Hospital Admission to Hospital Discharge ] [ Designated as safety issue: No ]Subjects will be followed from hospital admission to hospital discharge.
- Changes in cerebral and somatic oxygenation [ Time Frame: During Inter-facility Transport (Average) ] [ Designated as safety issue: No ]Utilizing NIRS Technology
| Estimated Enrollment: | 200 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
-
Procedure: Goal-directed Therapeutic Protocol
Eligibility| Ages Eligible for Study: | 1 Month to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01293500
| Contact: Michael H Stroud, MD | 501-364-1861 | StroudMichaelH@uams.edu |
| United States, Arkansas | |
| Arkansas Children's Hospital | Recruiting |
| Little rock, Arkansas, United States, 72202 | |
| Contact: Michael H Stroud, MD 501-364-1861 StroudMichaelH@uams.edu | |
| Principal Investigator: Michael H Stroud, MD | |
| Principal Investigator: | Michael H Stroud, MD | Arkansas Children's Hospital Research Institute |
More Information
No publications provided
| Responsible Party: | Arkansas Children's Hospital Research Institute |
| ClinicalTrials.gov Identifier: | NCT01293500 History of Changes |
| Other Study ID Numbers: | 1R21HD060171-01A2 |
| Study First Received: | October 22, 2010 |
| Last Updated: | January 18, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Arkansas Children's Hospital Research Institute:
|
SIRS shock sepsis pediatric |
inter-facility transport specialized transport NIRS monitoring |
Additional relevant MeSH terms:
|
Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Shock |
ClinicalTrials.gov processed this record on March 01, 2015