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 14, 2018
|Condition or disease||Intervention/treatment|
|Trauma||Device: esophageal Doppler|
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|
|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, 2019|
|Estimated Study Completion Date :||September 30, 2019|
Monitoring arterial pressure, central venous pressure and pulse pressure variation
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
- 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.
- 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
- Creatinine [ Time Frame: Immediate postop ]Kidney function
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
|Contact: In Kyong Yi, MDemail@example.com|
|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 firstname.lastname@example.org|
|Contact: Yoon Jung Chae, MD +82-31-219-5689|
|Principal Investigator:||In Kyong Yi, MD||Ajou University School of Medicine|