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Hemodynamic Monitoring

FloTrac™ and EV1000™ peri-operatively for Difficult Weaning (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
No Placebo-Only Group

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
  • Difficult Weaning
  • Critical Illness
  • Trauma

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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
182 Previous Clinical Trials
62,821 Total Patients Enrolled
CAMC Health SystemLead Sponsor
45 Previous Clinical Trials
7,870 Total Patients Enrolled
Audis Bethea, PharmD, BCPSPrincipal InvestigatorCAMC Health System
4 Previous Clinical Trials
494 Total Patients Enrolled
~20 spots leftby Nov 2025