Systemic Inflammatory Response SyndromeGRIPITNCT01293500
Goal-directed Resuscitative Interventions During Pediatric Inter-facility Transport (The GRIPIT Trial)
A study testing Goal-directed Therapeutic Protocol in people with Systemic Inflammatory Response Syndrome, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 17 years
- Conditions the study is for
- Systemic Inflammatory Response Syndrome
- What is being tested?
- Goal-directed Therapeutic Protocol
- Type of treatment
- Surgery or procedure
- How many people
- 230 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
About this study
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.
- Conditions
- Systemic Inflammatory Response Syndrome
- Being tested
- Goal-directed Therapeutic Protocol
- Keywords
- SIRS, shock, sepsis, pediatric, inter-facility transport, specialized transport, NIRS monitoring
- Medical subject headings
- Systemic Inflammatory Response Syndrome, Shock, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal-directed Therapeutic ProtocolProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Multiple Organ Dysfunction
Computed utilizing PELOD scores.
Measured: ICU Admission to ICU Discharge
Required ICU Interventions
Utilizing TISS-28 Scores
Measured: ICU Admission to ICU Discharge
Hospital Length of Stay
Subjects will be followed from hospital admission to hospital discharge.
Measured: Hospital Admission to Hospital Discharge
Secondary outcomes (1)
Changes in cerebral and somatic oxygenation
Utilizing NIRS Technology
Measured: During Inter-facility Transport (Average)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2011 (estimated)
- Study startOct 2010
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic Inflammatory Response SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Michael H Stroud, MD, Principal investigator, Arkansas Children's Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01293500
- Sponsor's protocol ID
- 1R21HD060171-01A2
- Acronym
- GRIPIT
- Status last verified
- May 2016
- First submitted
- 22 Oct 2010
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25860203
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Goal-directed Resuscitative Interventions During Pediatric Inter-facility Transport (The GRIPIT Trial)
- ClinicalTrials.gov ID
- NCT01293500
- Acronym / sponsor ID
- GRIPIT / 1R21HD060171-01A2
- Conditions
- Systemic Inflammatory Response Syndrome
- Keywords
- SIRS, shock, sepsis, pediatric, inter-facility transport, specialized transport, NIRS monitoring
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Oct 2010
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 10 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 1 month to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Goal-directed Therapeutic ProtocolA 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. | Procedure or surgery | – |
Primary outcome
Incidence of Multiple Organ Dysfunction
Time frame: ICU Admission to ICU Discharge
Computed utilizing PELOD scores.
Required ICU Interventions
Time frame: ICU Admission to ICU Discharge
Utilizing TISS-28 Scores
Hospital Length of Stay
Time frame: Hospital Admission to Hospital Discharge
Subjects will be followed from hospital admission to hospital discharge.
1 secondary outcome
Changes in cerebral and somatic oxygenation
Time frame: During Inter-facility Transport (Average)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Derived from this study: PubMed 25860203Stroud 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael H Stroud, MD principal investigator
Arkansas Children's Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goal-directed Therapeutic Protocol in people with Systemic Inflammatory Response Syndrome, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Multiple Organ Dysfunction (time frame: ICU Admission to ICU Discharge). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01293500, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.