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Less fluid, better recovery? new trial tests approach in injured kids

NCT ID NCT04201704

Disease control Sponsor: Columbia University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 looks at whether giving less intravenous (IV) fluid to critically ill children with traumatic injuries leads to fewer complications. Currently, there is no standard for how much fluid these children should receive. The trial will enroll 250 children aged 6 months to 15 years in pediatric intensive care units (PICUs) and compare a restricted fluid strategy to usual care. The goal is to see if less fluid reduces problems like fluid buildup in the lungs, bleeding, infections, and other serious complications.

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

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2018

Expected to finish

Sep 2027

An estimate. End dates often move.

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

6 months to 15 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: * Trauma patients older than 6 months and younger than 15 years admitted to the pediatric intensive care unit (PICU) * Patients admitted to the PICU directly from the Emergency Department (ED) * Patients admitted to the PICU from the operating room (OR) * Patients transferred to PICU from outside facility ED (need to have been in ED 12 hours or less) Exclusion Criteria: * Patients transferred to PICU from outside PICU or inpatient floor * Patients transferred to PICU from outside facility ED if \>12 hours * Patients expected to be discharged from the PICU within 24 hours * Patient with congenital heart disease as defined by a congenital cardiac defect requiring surgery or medication * Patient with diagnosis of chronic cardiac condition (e.g. hypertension, cardiac arrhythmia) * Patients with chronic kidney disease as defined by an abnormality of kidney structure or function, present for more than 3 months, with implications to health * Post-operative transplant, cardiac, and neurosurgical patients * Patients with traumatic brain injury * Patients with any disease that may affect baseline blood pressure and heart rate (endocrine disorders, certain genetic disorders, mitochondrial diseases) * Hypotension requiring vasopressor therapy * If massive transfusion protocol initiated

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Conditions

The condition(s) this trial relates to.

Critical Illness injury Multiple Trauma Postoperative Complications

As listed by the trial registrant

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

Critical illness Fluid therapy General surgery Pediatrics Wounds and injuries

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Columbia University Irving Medical Center NewYork-Presbyterian Morgan Stanley Children's Hospital

    RECRUITING

    New York, New York, 10032, United States

  • John R. Oishei Children's Hospital of Buffalo

    NOT_YET_RECRUITING

    Buffalo, New York, 14203, United States

  • Le Bonheur Children's Hospital

    RECRUITING

    Memphis, Tennessee, 38103, United States

  • University of Rochester, Golisano Children's Hospital

    RECRUITING

    Rochester, New York, 14642, United States

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