Fluid resuscitation optimization in surgical trauma patients (FROST)

NCT ID NCT02742974

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 09, 2026 · Last updated Sep 09, 2026

Summary

The aim of this study is to determine if the incidence of post-operative complications can be decreased by the implementation of intra-operative, minimally invasive hemodynamic monitoring (MIHM) via FloTrac™ and EV1000™ in trauma patients.

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

48 people

The number who actually took part.

Started

Oct 2015

Finished

Nov 2017

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

18 years and older

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: 1. 18 years of age or older 2. Injury Severity Score \> 15 (indicator of anticipated trauma mortality) 3. Admission to Surgical-Trauma ICU (STICU) 4. Anticipated surgery within 72 hours of admission 5. American Society of Anesthesiology patient classification status (ASA) 2-5 6. Lactic acid \> 2.5 within 24 hours of surgical procedure or Base deficit ≥ - 5 mmol/L, or persistent requirement for vasopressor support within 24 hours of surgical procedure 7. Patient requires mechanical ventilation prior to consenting surgery 8. Vascular devices that include a minimum of an arterial line 9. Minimally invasive hemodynamic monitoring initiated prior to first surgical procedure unless patient is taken emergently, e.g. OR from trauma bay 10. Patients requiring emergent initial operative procedures will be eligible for consenting if above criteria are met prior to their second surgical procedure 11. Anticipated operative procedure precipitating evaluation and/or consenting for study must be \> 30 minutes in duration * Procedures \< 30 minutes would not result in significant metabolic stress necessitating a continuation of MIHM Exclusion Criteria: 1. Pregnancy 2. Exclusions due to limitations with respect to accuracy of MIHM: * Patients not intubated prior to surgical procedure * Patients requiring an open thoracotomy * Patients with known history of surgical intervention for peripheral vascular disease * Patients with pre-existing atrial arrhythmias * Patients who are on cardiopulmonary bypass 3. Isolated acute cerebral injury and/or traumatic cerebral injury * Hemodynamic management in this patient population does not always follow typical/standard endpoints due to nuances of managing intracranial pressures 4. Cardiac arrest prior to enrollment 5. Patients with pre-existing, dialysis dependent, renal failure upon admission * Hemodynamic management in this patient population does not always follow typical/standard endpoints due to nuances of managing renal failure 6. Patients with pre-existing cirrhosis * Hepatic failure results in abnormal clearance of lactic acid 7. Patients with no survival injuries, e.g. gunshot wound to the head

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Conditions

The condition(s) this trial relates to.

Critical Illness injury

As listed by the trial registrant

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

Contacts and locations

Locations

  • Charleston Area Medical Center, General Hospital

    Charleston, West Virginia, 25301, United States

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