The Effect of Esophageal Doppler Guided Goal-directed Hemodynamic Therapy in Severe Trauma Patients (GDT)

October 24, 2019 updated by: In-kyong Yi, Ajou University School of Medicine

The Effect of Esophageal Doppler Guided Goal-directed Hemodynamic Therapy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Goal directed fluid therapy becomes issue for enhanced recovery after surgery. In goal directed therapy, dynamic parameters, like stroke volume and cardiac output, is important. Esophageal Doppler is one of device which provides dymanic parameters.

In severe trauma cases, the effect of goal directed therapy is not known yet. So the aim of this study is comparing the results of goal directed therapy using esophageal Doppler and conventional fluid therapy.

Study Type

Observational

Enrollment (Actual)

46

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

    • Gyeonggi-do
      • Suwon, Gyeonggi-do, Korea, Republic of, 16499
        • Ajou University School of Medicine

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

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Severe trauma patients

: Injury severity score > 15

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Goal directed fluid therapy using dynamic parameters from esophageal Doppler

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lactate
Time Frame: Immediate postoperative (=initial ICU admission)

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute Physiology and Chronic Health Evaluation II (APACHE II) score
Time Frame: Immediate postoperative
ICU patient scoring system, score from 0 to 71, higher scores correspond to more severe disease and a higher risk of death
Immediate postoperative
Creatinine
Time Frame: Immediate postop
Kidney function
Immediate postop

Collaborators and Investigators

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

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)

November 6, 2017

Primary Completion (Actual)

August 31, 2019

Study Completion (Actual)

September 30, 2019

Study Registration Dates

First Submitted

November 5, 2017

First Submitted That Met QC Criteria

November 8, 2017

First Posted (Actual)

November 13, 2017

Study Record Updates

Last Update Posted (Actual)

October 28, 2019

Last Update Submitted That Met QC Criteria

October 24, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MED-OBS-17-314

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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