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Completed

NCT Number: NCT03339375

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

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

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Key information

Conditions

Trauma Wounds and Injuries

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ajou university school of medicine

Suwon, Gyeonggi-do, 16499, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Esophageal Doppler

Device

Goal directed fluid therapy using dynamic parameters from esophageal Doppler

Primary outcomes

  1. 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

  1. 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

  2. Creatinine

    Time frame: Immediate postop

    Kidney function

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Registry information

Official study title

The Effect of Esophageal Doppler Guided Goal-directed Hemodynamic Therapy

Acronym: GDT

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 13, 2017
Registry last updated
Oct 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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