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Hemodynamic Monitoring

FloTrac™ and EV1000™ peri-operatively for Critical Illness (FROST Trial)

N/A
Waitlist Available
Led By Audis Bethea, PharmD, BCPS
Research Sponsored by CAMC Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during patient hospital stay up to 6 months
Awards & highlights

FROST Trial 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.

Eligible Conditions
  • Critical Illness
  • Trauma

FROST Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during patient hospital stay up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and during patient hospital stay up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complications
Secondary outcome measures
APACHE II
Changes in pre and post-operative APACHE II score
Changes in pre and post-operative lactic acid and base deficit
+3 more

FROST Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: FloTrac™ and EV1000™ peri-operativelyExperimental Treatment1 Intervention
Cardiovascular management guided by minimally invasive hemodynamic monitoring via FloTrac™ and EV1000™ will be utilized in the perioperative period for the intervention arm
Group II: FloTrac™ and EV1000™ pre and post-operativelyActive Control1 Intervention
Cardiovascular management guided by minimally invasive hemodynamic monitoring via FloTrac™ and EV1000™ will be utilized in the pre and post-operative period in the control arm.

Find a Location

Who is running the clinical trial?

Edwards LifesciencesIndustry Sponsor
180 Previous Clinical Trials
61,378 Total Patients Enrolled
CAMC Health SystemLead Sponsor
45 Previous Clinical Trials
7,870 Total Patients Enrolled
1 Trials studying Critical Illness
5 Patients Enrolled for Critical Illness
Audis Bethea, PharmD, BCPSPrincipal InvestigatorCAMC Health System
4 Previous Clinical Trials
494 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
BmjJournal
Intraoperative Intravascular Volume Optimisation and Length of Hospital Stay After Repair of Proximal Femoral Fracture: Randomised Controlled Trial
Sinclair, S., S. James, and M. Singer. 1997. “Intraoperative Intravascular Volume Optimisation and Length of Hospital Stay After Repair of Proximal Femoral Fracture: Randomised Controlled Trial”. Bmj. BMJ. doi:10.1136/bmj.315.7113.909.
clinicaltrials.govStudy
Fluid Resuscitation Optimization in Surgical Trauma Patients (FROST)
2015. "Fluid Resuscitation Optimization in Surgical Trauma Patients (FROST)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02742974.
All > Trauma
~21 spots leftby Apr 2025
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