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NCT01293500 · ClinicalTrials.gov registry record · NA
Goal-directed Resuscitative Interventions During Pediatric Inter-facility Transport (The GRIPIT Trial)
A NA study, sponsored by Arkansas Children's Hospital Research Institute.
- Terminated
- Registry status
- NA
- Development phase
- 230
- Enrollment target
NCT01293500 is a NA study that was terminated before completion, run by Arkansas Children's Hospital Research Institute. The registered enrollment target is 230 participants.
The verdict
NCT01293500, a NA study, was terminated before completion, sponsored by Arkansas Children's Hospital Research Institute.
- TERMINATED
- Registry status
- NA
- Development phase
- 230 participants
- Enrollment target
Study 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.
Interventions
- PROCEDURE Goal-directed Therapeutic Protocol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 230 participants |
| Start Date | 2010-10 |
| Est. Completion | 2014-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01293500
The ClinicalTrials.gov registry entry for NCT01293500 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 230 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Arkansas Children's Hospital Research Institute, which has 97 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Goal-directed Therapeutic Protocol is the first listed.
NCT01293500 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01293500 about?
NCT01293500 is a clinical study titled "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 Inflam...
What is the current status of trial NCT01293500?
This trial is currently terminated. It is a NA study. The enrollment target is 230 participants. The study started on 2010-10. Estimated completion is 2014-11.
What interventions are being tested in trial NCT01293500?
The interventions under investigation include: Goal-directed Therapeutic Protocol (PROCEDURE).
Who is sponsoring clinical trial NCT01293500?
This trial is sponsored by Arkansas Children's Hospital Research Institute, which has 97 total clinical trials registered on ClinicalTrials.gov.
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