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

Trauma Clinical Trial

— GDT  

Official title:

The Effect of Esophageal Doppler Guided Goal-directed Hemodynamic Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03339375
• Other study ID #: MED-OBS-17-314
• Status: Completed
• Start date: November 6, 2017
• Est. completion date: September 30, 2019

Study information

• Verified date: October 2019
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: September 30, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Trauma
• Wounds and Injuries

Intervention

Device:
• esophageal Doppler
Goal directed fluid therapy using dynamic parameters from esophageal Doppler

Locations

Country	Name	City	State
Korea, Republic of	Ajou university school of medicine	Suwon	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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