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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
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute

Study Description
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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.


Condition or disease Intervention/treatment Phase
SIRS (Systemic Inflammatory Response Syndrome( Procedure: Goal-directed Therapeutic Protocol Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

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U.S. FDA Resources

Arms and Interventions
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Intervention Details:
    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.

Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Multiple Organ Dysfunction [ Time Frame: ICU Admission to ICU Discharge ]
    Computed utilizing PELOD scores.

  2. Required ICU Interventions [ Time Frame: ICU Admission to ICU Discharge ]
    Utilizing TISS-28 Scores

  3. Hospital Length of Stay [ Time Frame: Hospital Admission to Hospital Discharge ]
    Subjects will be followed from hospital admission to hospital discharge.


Secondary Outcome Measures :
  1. Changes in cerebral and somatic oxygenation [ Time Frame: During Inter-facility Transport (Average) ]
    Utilizing NIRS Technology


Eligibility Criteria
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Ages Eligible for Study:   1 Month to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
United States, Arkansas
Arkansas Children's Hospital
Little rock, Arkansas, United States, 72202
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Michael H Stroud, MD Arkansas Children's Hospital Research Institute
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01293500     History of Changes
Other Study ID Numbers: 1R21HD060171-01A2 ( U.S. NIH Grant/Contract )
First Posted: February 10, 2011    Key Record Dates
Last Update Posted: May 5, 2016
Last Verified: May 2016

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