- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03339375
The Effect of Esophageal Doppler Guided Goal-directed Hemodynamic Therapy in Severe Trauma Patients (GDT)
The Effect of Esophageal Doppler Guided Goal-directed Hemodynamic Therapy
Study Overview
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Gyeonggi-do
-
Suwon, Gyeonggi-do, Korea, Republic of, 16499
- Ajou University School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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