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

October 22, 2010
January 18, 2012
October 2010
September 2012   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01293500 on ClinicalTrials.gov Archive Site
Changes in cerebral and somatic oxygenation [ Time Frame: During Inter-facility Transport (Average) ] [ Designated as safety issue: No ]
Utilizing NIRS Technology
Same as current
Not Provided
Not Provided
 
Goal-directed Resuscitative Interventions During Pediatric Inter-facility Transport (The GRIPIT Trial)
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 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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
SIRS (Systemic Inflammatory Response Syndrome(
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
September 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
1 Month to 17 Years
No
Contact: Michael H Stroud, MD 501-364-1861 StroudMichaelH@uams.edu
United States
 
NCT01293500
1R21HD060171-01A2
Yes
Arkansas Children's Hospital Research Institute
Arkansas Children's Hospital Research Institute
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Michael H Stroud, MD Arkansas Children's Hospital Research Institute
Arkansas Children's Hospital Research Institute
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP