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New protocol aims to start lifesaving care for kids with sepsis en route to hospital

NCT ID NCT01293500

Disease control Sponsor: Arkansas Children's Hospital Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a standardized, goal-directed treatment plan given during ambulance transport could improve outcomes for children with Systemic Inflammatory Response Syndrome (SIRS), a severe inflammatory condition. Researchers planned to compare outcomes before and after implementing the protocol in 230 children. The trial was terminated early, so its findings are limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Goal-directed therapeutic protocol (a standardized care plan) and NIRS monitoring
What this could lead to
If successful, this approach could improve survival and reduce hospital stays for critically ill children with SIRS by starting treatment earlier during transport.
What could go wrong
The trial was terminated, so results are limited. It was also a small, single-center study comparing time periods, not a randomized test, making it hard to draw firm conclusions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

230 people

The number who actually took part.

Start date

Oct 2010

Finished

Nov 2014

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 month to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Sepsis Shock Systemic Inflammatory Response Syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Systemic inflammatory response syndrome

Contacts and locations

Locations

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.