Goal-directed Resuscitative Interventions During Pediatric Inter-facility Transport (The GRIPIT Trial) (GRIPIT)
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|ClinicalTrials.gov Identifier: NCT01293500|
Recruitment Status : Terminated
First Posted : February 10, 2011
Last Update Posted : May 5, 2016
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 or disease||Intervention/treatment||Phase|
|SIRS (Systemic Inflammatory Response Syndrome(||Procedure: Goal-directed Therapeutic Protocol||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||230 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Goal-directed Resuscitative Interventions During Pediatric Inter-facility Transport (The GRIPIT Trial)|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||November 2014|
- Procedure: Goal-directed Therapeutic Protocol
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.
- Incidence of Multiple Organ Dysfunction [ Time Frame: ICU Admission to ICU Discharge ]Computed utilizing PELOD scores.
- Required ICU Interventions [ Time Frame: ICU Admission to ICU Discharge ]Utilizing TISS-28 Scores
- Hospital Length of Stay [ Time Frame: Hospital Admission to Hospital Discharge ]Subjects will be followed from hospital admission to hospital discharge.
- Changes in cerebral and somatic oxygenation [ Time Frame: During Inter-facility Transport (Average) ]Utilizing NIRS Technology
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01293500
|United States, Arkansas|
|Arkansas Children's Hospital|
|Little rock, Arkansas, United States, 72202|
|Principal Investigator:||Michael H Stroud, MD||Arkansas Children's Hospital Research Institute|