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

Primary Purpose

SIRS (Systemic Inflammatory Response Syndrome(

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Goal-directed Therapeutic Protocol
Sponsored by
Arkansas Children's Hospital Research Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for SIRS (Systemic Inflammatory Response Syndrome( focused on measuring SIRS, shock, sepsis, pediatric, inter-facility transport, specialized transport, NIRS monitoring

Eligibility Criteria

1 Month - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arkansas Children's Hospital

Outcomes

Primary Outcome Measures

Incidence of Multiple Organ Dysfunction
Computed utilizing PELOD scores.
Required ICU Interventions
Utilizing TISS-28 Scores
Hospital Length of Stay
Subjects will be followed from hospital admission to hospital discharge.

Secondary Outcome Measures

Changes in cerebral and somatic oxygenation
Utilizing NIRS Technology

Full Information

First Posted
October 22, 2010
Last Updated
May 3, 2016
Sponsor
Arkansas Children's Hospital Research Institute
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT01293500
Brief Title
Goal-directed Resuscitative Interventions During Pediatric Inter-facility Transport (The GRIPIT Trial)
Acronym
GRIPIT
Official Title
Goal-directed Resuscitative Interventions During Pediatric Inter-facility Transport (The GRIPIT Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Terminated
Study Start Date
October 2010 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arkansas Children's Hospital Research Institute
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SIRS (Systemic Inflammatory Response Syndrome(
Keywords
SIRS, shock, sepsis, pediatric, inter-facility transport, specialized transport, NIRS monitoring

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
230 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Goal-directed Therapeutic Protocol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of Multiple Organ Dysfunction
Description
Computed utilizing PELOD scores.
Time Frame
ICU Admission to ICU Discharge
Title
Required ICU Interventions
Description
Utilizing TISS-28 Scores
Time Frame
ICU Admission to ICU Discharge
Title
Hospital Length of Stay
Description
Subjects will be followed from hospital admission to hospital discharge.
Time Frame
Hospital Admission to Hospital Discharge
Secondary Outcome Measure Information:
Title
Changes in cerebral and somatic oxygenation
Description
Utilizing NIRS Technology
Time Frame
During Inter-facility Transport (Average)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael H Stroud, MD
Organizational Affiliation
Arkansas Children's Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arkansas Children's Hospital
City
Little rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25860203
Citation
Stroud MH, Sanders RC Jr, Moss MM, Sullivan JE, Prodhan P, Melguizo-Castro M, Nick T. Goal-Directed Resuscitative Interventions During Pediatric Interfacility Transport. Crit Care Med. 2015 Aug;43(8):1692-8. doi: 10.1097/CCM.0000000000001021.
Results Reference
derived

Learn more about this trial

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

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