TraumaGDTNCT03339375
The Effect of Esophageal Doppler Guided Goal-directed Hemodynamic Therapy in Severe Trauma Patients
An observational study of Trauma, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
Prospective randomized clinical trial Compare the goal-directed fluid therapy using esophageal Doppler and classic fluid therapy Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Trauma
- What is being tested?
- esophageal Doppler
- Type of treatment
- Medical device
- How many people
- 46 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Nov 2017to 30 Sep 2019
- How long will I take part?
- 3 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Severe trauma patients : Injury severity score > 15
Who may be able to join
- Severe trauma patients who undergo general anesthesia
- Initial serum lactate level > 2mmol/L
Who cannot join
- Severe traumatic brain injury
- THoracic surgery
- Age < 19 years old
- Impending arrest or post CPR state
- Severe facial trauma
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Ajou university school of medicine
Suwon, Gyeonggi-do, 16499
About this study
Official title: The Effect of Esophageal Doppler Guided Goal-directed Hemodynamic Therapy
Prospective randomized clinical trial Compare the goal-directed fluid therapy using esophageal Doppler and classic fluid therapy
Read the 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.
- Conditions
- Trauma
- Being tested
- esophageal Doppler
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esophageal DopplerDevice
Goal directed fluid therapy using dynamic parameters from esophageal Doppler
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: esophageal Doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lactate
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.
Measured: Immediate postoperative (=initial ICU admission)
Secondary outcomes (2)
Acute Physiology and Chronic Health Evaluation II (APACHE II) score
ICU patient scoring system, score from 0 to 71, higher scores correspond to more severe disease and a higher risk of death
Measured: Immediate postoperative
Creatinine
Kidney function
Measured: Immediate postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start6 Nov 2017
- Primary completion31 Aug 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In-kyong Yi, Ajou University School of Medicine
- Investigators
- In Kyong Yi, MD, Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03339375
- Sponsor's protocol ID
- MED-OBS-17-314
- Acronym
- GDT
- Status last verified
- Oct 2019
- First submitted
- 5 Nov 2017
- Last updated
- 28 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Esophageal Doppler Guided Goal-directed Hemodynamic Therapy
- ClinicalTrials.gov ID
- NCT03339375
- Acronym / sponsor ID
- GDT / MED-OBS-17-314
- Conditions
- Trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 13 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | – | –Monitoring arterial pressure, central venous pressure and pulse pressure variation |
| esophagela Doppler | – | Device: esophageal DopplerMonitoring 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 |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Severe trauma patients : Injury severity score > 15
Key inclusion criteria (2 listed)
- Severe trauma patients who undergo general anesthesia
- Initial serum lactate level > 2mmol/L
Key exclusion criteria (5 listed)
- Severe traumatic brain injury
- THoracic surgery
- Age < 19 years old
- Impending arrest or post CPR state
- Severe facial trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| esophageal DopplerGoal directed fluid therapy using dynamic parameters from esophageal Doppler | Device | esophagela Doppler |
Primary outcome
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.
2 secondary outcomes
Acute Physiology and Chronic Health Evaluation II (APACHE II) score
Time frame: Immediate postoperative
Creatinine
Time frame: Immediate postop
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
In Kyong Yi, MD principal investigator
Ajou University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma, run by Ajou University School of Medicine at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lactate (time frame: Immediate postoperative (=initial ICU admission)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2019.