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Clinical Trials/NCT03339375
NCT03339375
Completed
Not Applicable

The Effect of Esophageal Doppler Guided Goal-directed Hemodynamic Therapy

Ajou University School of Medicine1 site in 1 country46 target enrollmentNovember 6, 2017
ConditionsTrauma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Trauma
Sponsor
Ajou University School of Medicine
Enrollment
46
Locations
1
Primary Endpoint
Lactate
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 6, 2017
End Date
September 30, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Ajou University School of Medicine
Responsible Party
Principal Investigator
Principal Investigator

In-kyong Yi

Clinical assistant professor

Ajou University School of Medicine

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Creatinine(Immediate postop)
  • Acute Physiology and Chronic Health Evaluation II (APACHE II) score(Immediate postoperative)

Study Sites (1)

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