Fluid Resuscitation Optimization in Surgical Trauma Patients (FROST) (FROST)

September 4, 2026 updated by: CAMC Health System
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Numerous factors are known to contribute to post-traumatic morbidity and mortality. Acute blood loss, hypovolemia, and systemic inflammatory response syndrome can often develop following severe traumatic injury and are, frequently, further exacerbated by the presence of pre-existing health conditions. The culmination of these insults and/or pre-existing conditions can precipitate an imbalance in oxygen delivery and consumption leading to tissue ischemia and resultant organ dysfunction.

Tissue ischemia precipitates a disruption in the balance of oxygen delivery and consumption often yielding a conversion from aerobic to anaerobic processes in order to maintain metabolic functionality. The conversion to anaerobic processes leads to the production of lactic acid and a resulting consumption of the body's basic buffers. Clinically, the consumption of the body's basic buffers is frequently referred to as the development of a base deficit. Both the production of lactic acid and the development of a base deficit have been positively linked to the increased morbidity and mortality in multiple critically ill patient populations, including those with traumatic injuries.

Multiple studies have linked the rate at which base deficit corrects or lactic acid clears to the likelihood of survival. Accordingly, hemodynamic monitoring can provide vital information concerning cardiovascular function including vascular volume, vascular capacitance, and cardiac performance. Obtaining this information enables clinicians to tailor interventions to target specific components of the cardiovascular system in order to most effectively reverse the cause of tissue hypoxia, elevation in lactic acid, and base deficit, while simultaneously decreasing the likelihood of causing harm through unnecessary or unwarranted changes in management.

Advancements in hemodynamic monitoring technology now allow clinicians to obtain data by using minimally invasive techniques. Devices utilizing this technology can be connected to vascular access routinely utilized in the intensive care setting such as arterial lines. These devices provide parameters such as systolic pressure variation (SPV), pulse pressure variation (PPV) and stroke volume variation (SVV) to predict fluid responsiveness of critically ill, mechanically ventilated patients. Studies evaluating these parameters have shown them to have a 84-94% positive predictive value for fluid responsiveness. In addition, higher variability in studied parameters were indicative of patients who were more likely to be responsive to fluid challenges.

Modern clinical management in critically ill patients with cardiovascular dysfunction hinges on reversal of the underlying cause of cardiovascular dysfunction. Recent management strategies have used a multi-faceted approach in which multiple processes of potential dysfunction can be monitored and managed simultaneously. Management is goal directed with clearly defined endpoints for the management of vascular volume, cardiac performance as well as maintenance of vascular capacitance. Hemodynamic monitoring technology is essential in providing data that will allow clinical interventions to be tailored to patient-specific physiology and provide goals for titration of therapy.

In recent years, data has emerged using goal directed therapy in the surgical patient population with favorable outcomes suggesting a decrease in post-operative organ dysfunction, ICU and hospital length of stay, however, there is limited data in the trauma patient population. This study endeavors to determine if the implementation of intra-operative monitoring will decrease the incidence of post-operative complications such as acute lung injury, infections, thromboembolism, cerebral vascular accident, acute kidney injury, myocardial infarction; in addition to the traditional outcome measures of mortality and length of stay.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • West Virginia
      • Charleston, West Virginia, United States, 25301
        • Charleston Area Medical Center, General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: FloTrac™ and EV1000™ pre and post-operatively
Cardiovascular interventions guided by minimally invasive hemodynamic monitoring via FloTrac™ and EV1000™ in the pre and post-operative period in the control arm.
Device: Device: FloTrac™ and EV1000™
Minimally invasive hemodynamic monitoring utilizing the FloTrac sensor and EV1000 platform to continuously assess cardiovascular parameters for clinical management.
Experimental: FloTrac™ and EV1000™ peri-operatively
Cardiovascular interventions guided by minimally invasive hemodynamic monitoring via FloTrac™ and EV1000™ in the perioperative period for the intervention arm
Device: Device: FloTrac™ and EV1000™
Minimally invasive hemodynamic monitoring utilizing the FloTrac sensor and EV1000 platform to continuously assess cardiovascular parameters for clinical management.
Other: Volume Challenge
Protocol-directed fluid administration for optimization of stroke volume variation and cardiac performance. Volume challenge options included crystalloids (normal saline, hypertonic saline, lactated Ringer's), blood products, and albumin
Drug: Vasopressor Therapy
Protocol-directed vasopressor administration based on hemodynamic monitoring data. Agents included norepinephrine, phenylephrine, epinephrine, dopamine, and vasopressin.
Drug: Inotropic Therapy
Protocol-directed inotropic support based on hemodynamic monitoring data. Agents included dobutamine and dopamine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: Post-operative complications during patient hospital stay up to 6 months
The aim of this study is to determine if the incidence of post-operative complications will decreased with the implementation of intra-operative, minimally invasive hemodynamic monitoring via FloTrac™ and EV1000™ in trauma patients.
Post-operative complications during patient hospital stay up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SOFA scores
Time Frame: Within 24 hours pre and post-surgery
Sepsis-related Organ Failure (SOFA) score between study cohorts. These scores will be recorded in whole numbers.
Within 24 hours pre and post-surgery
Changes in pre and post-operative lactic acid and base deficit
Time Frame: Within 24 hours pre and post-surgery
To compare changes in pre and post-operative lactic acid and based deficit between cohorts based on duration of surgical interventions. Both lactic acid and base deficit values will be recorded in mmoL/L.
Within 24 hours pre and post-surgery
Changes in pre and post-operative APACHE II score
Time Frame: Within 24 hours pre and post-surgery
To compare changes in pre and post-operative APACHE II scores between cohorts based on duration of surgical interventions. This score will be recorded in whole numbers.
Within 24 hours pre and post-surgery
Impact of Intervention on ICU/Hospital mortality rate
Time Frame: During patient hospital stay up to 6 months

To evaluate the impact of continuing intra-operative minimally invasive hemodynamic monitoring via FloTrac™ and EV1000™ :

-ICU and hospital mortality rate
During patient hospital stay up to 6 months
ICU Length of Stay
Time Frame: Through ICU discharge, an average of 30 days
Duration of stay in the ICU following surgery
Through ICU discharge, an average of 30 days
Duration of Post-operative Vasopressor Requirement
Time Frame: From completion of surgery until vasopressor discontinuation or hospital discharge (up to 6 months)
Need for vasopressor therapy following surgery
From completion of surgery until vasopressor discontinuation or hospital discharge (up to 6 months)
Hospital length of stay
Time Frame: During hospitalization up to 6 months
Duration of hospitalization following surgery
During hospitalization up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CAMC Health System

Collaborators

Edwards Lifesciences

Investigators

  • Principal Investigator: Audis Bethea, PharmD, BCPS, CAMC Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

February 10, 2016

First Submitted That Met QC Criteria

April 14, 2016

First Posted (Estimated)

April 19, 2016

Study Record Updates

Last Update Posted (Actual)

September 9, 2026

Last Update Submitted That Met QC Criteria

September 4, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-159

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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