NCT03339375

Brief Summary

Prospective randomized clinical trial Compare the goal-directed fluid therapy using esophageal Doppler and classic fluid therapy

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

November 6, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 13, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

October 28, 2019

Status Verified

October 1, 2019

Enrollment Period

1.8 years

First QC Date

November 5, 2017

Last Update Submit

October 24, 2019

Conditions

Trauma

Outcome Measures

Primary Outcomes (1)

  • Lactate

    Unit is mmol/L Inclusion criteria is initial lactate \> 2mmol/L. Whole hospital use same device and unit to measure lactate. In this study, POCT lactate won't be used. After surgical resuscitation, lactate level is independent predictor of survival, because it represents tissue oxygenation.

    Immediate postoperative (=initial ICU admission)

Secondary Outcomes (2)

  • Acute Physiology and Chronic Health Evaluation II (APACHE II) score

    Immediate postoperative

  • Creatinine

    Immediate postop

Study Arms (2)

control

Monitoring arterial pressure, central venous pressure and pulse pressure variation

esophagela Doppler

Monitoring arterial pressure, central venous pressure Insertion of esophageal Doppler probe to patient Monitoring stroke volume, cardiac output, corrected flow time from esophageal Doppler Use stroke volume optimization goal directed therapy protocol

Device: esophageal Doppler

Interventions

esophageal DopplerDEVICE

Goal directed fluid therapy using dynamic parameters from esophageal Doppler

esophagela Doppler

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Severe trauma patients : Injury severity score \> 15

You may qualify if:

  • Severe trauma patients who undergo general anesthesia
  • Initial serum lactate level \> 2mmol/L

You may not qualify if:

  • Severe traumatic brain injury
  • THoracic surgery
  • Age \< 19 years old
  • Impending arrest or post CPR state
  • Severe facial trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou university school of medicine

Suwon, Gyeonggi-do, 16499, South Korea

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • In Kyong Yi, MD

    Ajou University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
3 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical assistant professor

Study Record Dates

First Submitted

November 5, 2017

First Posted

November 13, 2017

Study Start

November 6, 2017

Primary Completion

August 31, 2019

Study Completion

September 30, 2019

Last Updated

October 28, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)