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

Completed

• Conditions: Trauma
• Interventions: Device: esophageal Doppler

• Registration Number: NCT03339375
• Lead Sponsor: Ajou University School of Medicine

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-11-05
• Study Start: 2017-11-06
• Study First Submitted QC: 2017-11-08
• Study First Posted: 2017-11-13
• Primary Completion: 2019-08-31
• Study Completion: 2019-09-30
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-24
• Last Update Posted: 2019-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
esophagela Doppler	esophageal 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

Primary Outcome Measures

Name	Time	Method
Lactate	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ajou university school of medicine; 🇰🇷 Suwon, Gyeonggi-do, Korea, Republic of