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

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ClinicalTrials.gov Identifier: NCT03339375
Recruitment Status : Recruiting
First Posted : November 13, 2017
Last Update Posted : November 13, 2017
Sponsor:
Information provided by (Responsible Party):
In-kyong Yi, Ajou University School of Medicine

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

Condition or disease Intervention/treatment
Trauma Device: esophageal Doppler

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 : Observational [Patient Registry]
Estimated Enrollment : 164 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 3 Days
Official Title: The Effect of Esophageal Doppler Guided Goal-directed Hemodynamic Therapy
Actual Study Start Date : November 6, 2017
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : September 30, 2018

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Severe trauma patients

: Injury severity score > 15

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03339375


Contacts
Contact: In Kyong Yi, MD +82-10-3012-6972 lyrin01@hotmail.com

Locations
Korea, Republic of
Ajou university school of medicine Recruiting
Suwon, Gyeonggi-do, Korea, Republic of, 16499
Contact: In Kyong Yi, MD    +82-10-3012-6972    lyrin01@hotmail.com   
Contact: Yoon Jung Chae, MD    +82-31-219-5689      
Sponsors and Collaborators
Ajou University School of Medicine
Investigators
Principal Investigator: In Kyong Yi, MD Ajou University School of Medicine

Responsible Party: In-kyong Yi, Clinical assistant professor, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT03339375     History of Changes
Other Study ID Numbers: MED-OBS-17-314
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No