Goal-directed Resuscitative Interventions During Pediatric Inter-facility Transport (The GRIPIT Trial)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Arkansas Children's Hospital Research Institute.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01293500
First received: October 22, 2010
Last updated: January 18, 2012
Last verified: January 2012
  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)

Resource links provided by NLM:


Further study details as provided by Arkansas Children's Hospital Research Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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)
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.
  Eligibility

Ages Eligible for Study:   1 Month to 17 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01293500

Contacts
Contact: Michael H Stroud, MD 501-364-1861 StroudMichaelH@uams.edu

Locations
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         
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
Investigators
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 April 15, 2014