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Fluid Resuscitation Optimization in Surgical Trauma Patients (FROST)

NCT02742974 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2016-04-19

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

FloTrac™ and EV1000™

Interventions to improve cardiovascular performance will be made in all patients whose cardiovascular function is sub-optimal in accordance with routine clinical management during trauma resuscitation. Patients who meet inclusion criteria will be assigned to the intervention or control arm of the study based on the process outlined in the protocol. Patients assigned to the intervention arm will have intra-operative hemodynamic monitoring performed by the anesthesia staff and cardiovascular interventions will be based off of the algorithm described in the protocol. Members of anesthesia or the surgical team can initiate interventions as indicated during routine ICU care or intra-operatively.

Sponsors & Collaborators

  • Edwards Lifesciences

    collaborator INDUSTRY

  • CAMC Health System

    lead OTHER

Principal Investigators

  • Audis Bethea, PharmD, BCPS · CAMC Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2018-12-31
Completion
2019-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02742974 on ClinicalTrials.gov