Fluid resuscitation optimization in surgical trauma patients (FROST)
NCT ID NCT02742974
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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48 people
The number who actually took part.
- Started
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Oct 2015
- Finished
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Nov 2017
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Charleston Area Medical Center, General Hospital
Charleston, West Virginia, 25301, United States
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