Septic ShockECHO-VEVANCT07438301
Septic Shock Hemodynamic Respond to Volume Resuscitation Versus Vasopressor Administration
An observational study of Septic Shock, run by Mahidol University at 1 site in Thailand.
Trial summary
The goal of this observational study is to learn about the change of hemodynamic response from intravenous fluid versus medical (vasopressor) resuscitation by echocardiogram in septic shock patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- Echocardiogram
- How many people
- 180 participants
- Where
- 1 siteThailand
- Study dates
- 15 Mar 2026to 31 Jan 2028
- How long will I take part?
- 28 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult critically ill patients whom admitted to either medical or surgical intensive care units (MICU, SICU) at Siriraj Hospital
Who may be able to join
- Adult patients aged ≥18 years
- Diagnosis with Septic Shock (Sepsis-3 Definition of Septic Shock)
- Hypotension, SBP < 90 mmHg, or mean arterial BP < 65 mmHg
Who cannot join
- Patients who receive two or more vasopressors
- Patients who receive inotropic medications
- Patients who receive simultaneously fluid with vasopressor resuscitation
- Patients with insufficiently quality ultrasound images for determining echocardiography
- Patients or their legally authorized representatives (LAR), who decline participation in the study or are unable to provide informed consent before enrollment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site
Siriraj Hospital
Bangkok, 10700
Thitibud Treerasoradaj, MD, +66858494244, thitibud.tre@mahidol.ac.th
About this study
Official title: Echocardiographic Assessment the Different of Septic Shock Resuscitation: Comparison of Volume Expansion Versus Vasopressor Administration
The goal of this observational study is to learn about the change of hemodynamic response from intravenous fluid versus medical (vasopressor) resuscitation by echocardiogram in septic shock patient.
The main question it aims to answer is:
How hemodynamic response change from intravenous fluid versus medical (vasopressor) resuscitation by echocardiogram in septic shock patient?
Participants already receiving the appropriate resuscitation at that time by their medical staff as part of their regular medical care for septic shock. The echocardiogram will assess before and after resuscitation.
Read the detailed description
The goal of this observational study is to learn about the change of hemodynamic response from intravenous fluid versus medical (vasopressor) resuscitation by echocardiogram in septic shock patient.
The investigators enrolled septic shock patients, who required hemodynamic resuscitation. Then the investigators performed baseline echocardiogram to measured stroke volume, cardiac output and E/Ea before start resuscitation. In fluid resuscitation group, patient will received either fluid resuscitation about 200 mL to 500 mL before preformed echo after fluid resuscitation. In vasopressor group, patient will received norepinephrine titration dose about 0.05 mcg/kg/min, before performed echocardiogram. Then the investigators compare the different change between those resuscitation with fluid and with vasopressor titration, in term of stroke volume, cardiac output, cardiac index and E/Ea change.
- Conditions
- Septic Shock
- Being tested
- Echocardiogram
- Keywords
- sepsis, septic shock, hemodynamic, echocardiogram
- Medical subject headings
- Shock, Septic, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiogramDiagnostic test
Patient will be undergone echocardiogram for hemodynamic evaluation, before and after resuscitation by fluid and by vasopressor
| Study group | Role | What they receive |
|---|---|---|
| Fluid Resuscitation | Patient received fluid resuscitation Receives: Diagnostic Test: Echocardiogram | |
| Vasopressor Resuscitation | Patient received vasopressor titration Receives: Diagnostic Test: Echocardiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cardiac Index
Change of Cardiac Index from pre-to-post resuscitation
- Cardiac index before resuscitation
- Cardiac index 15minutes after resuscitation by IV fluid or Vasopressor (Post-resuscitation)
Measured: T0 = Cardiac index before resuscitation T1= Cardiac index 15minutes after resuscitation by IV fluid or Vasopressor (Post-resuscitation)
Secondary outcomes (2)
Change of other echocardiographic parameter from baseline to post-resuscitation.
Change in other echocardiographic parameter; IVC variation, Left ventricular ejection fraction, Left ventricular diastolic function in form of E/A ratio and E/E' ratio; from baseline to post-resuscitation;
Fluid resuscitation vs Vasopressor Resuscitation and its correlation with clinical parameters below
Measured: T0 = Echocardiographic parameters before resuscitation T1= Echocardiographic parameters 15minutes after resuscitation by IV fluid or Vasopressor (Post-resuscitation)
28-day Mortality
death outcome
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start15 Mar 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Surat Tongyoo, MD, Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07438301
- Sponsor's protocol ID
- SI 061/2024
- Acronym
- ECHO-VEVA
- Status last verified
- Feb 2026
- First submitted
- 25 May 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiographic Assessment the Different of Septic Shock Resuscitation: Comparison of Volume Expansion Versus Vasopressor Administration
- ClinicalTrials.gov ID
- NCT07438301
- Acronym / sponsor ID
- ECHO-VEVA / SI 061/2024
- Conditions
- Septic Shock
- Keywords
- sepsis, septic shock, hemodynamic, echocardiogram
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 27 Feb 2026 (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.
The goal of this observational study is to learn about the change of hemodynamic response from intravenous fluid versus medical (vasopressor) resuscitation by echocardiogram in septic shock patient.
The main question it aims to answer is:
How hemodynamic response change from intravenous fluid versus medical (vasopressor) resuscitation by echocardiogram in septic shock patient?
Participants already receiving the appropriate resuscitation at that time by their medical staff as part of their regular medical care for septic shock. The echocardiogram will assess before and after resuscitation.
Detailed description
The goal of this observational study is to learn about the change of hemodynamic response from intravenous fluid versus medical (vasopressor) resuscitation by echocardiogram in septic shock patient.
The investigators enrolled septic shock patients, who required hemodynamic resuscitation. Then the investigators performed baseline echocardiogram to measured stroke volume, cardiac output and E/Ea before start resuscitation. In fluid resuscitation group, patient will received either fluid resuscitation about 200 mL to 500 mL before preformed echo after fluid resuscitation. In vasopressor group, patient will received norepinephrine titration dose about 0.05 mcg/kg/min, before performed echocardiogram. Then the investigators compare the different change between those resuscitation with fluid and with vasopressor titration, in term of stroke volume, cardiac output, cardiac index and E/Ea change.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluid Resuscitation | – | Diagnostic Test: EchocardiogramPatient received fluid resuscitation |
| Vasopressor Resuscitation | – | Diagnostic Test: EchocardiogramPatient received vasopressor titration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult critically ill patients whom admitted to either medical or surgical intensive care units (MICU, SICU) at Siriraj Hospital
Key inclusion criteria (3 listed)
- Adult patients aged ≥18 years
- Diagnosis with Septic Shock (Sepsis-3 Definition of Septic Shock)
- Hypotension, SBP < 90 mmHg, or mean arterial BP < 65 mmHg
Key exclusion criteria (5 listed)
- Patients who receive two or more vasopressors
- Patients who receive inotropic medications
- Patients who receive simultaneously fluid with vasopressor resuscitation
- Patients with insufficiently quality ultrasound images for determining echocardiography
- Patients or their legally authorized representatives (LAR), who decline participation in the study or are unable to provide informed consent before enrollment
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 |
|---|---|---|
| EchocardiogramPatient will be undergone echocardiogram for hemodynamic evaluation, before and after resuscitation by fluid and by vasopressor | Diagnostic test | Fluid Resuscitation, Vasopressor Resuscitation |
Primary outcome
Change in Cardiac Index
Time frame: T0 = Cardiac index before resuscitation T1= Cardiac index 15minutes after resuscitation by IV fluid or Vasopressor (Post-resuscitation)
Change of Cardiac Index from pre-to-post resuscitation * Cardiac index before resuscitation * Cardiac index 15minutes after resuscitation by IV fluid or Vasopressor (Post-resuscitation)
2 secondary outcomes
Change of other echocardiographic parameter from baseline to post-resuscitation.
Time frame: T0 = Echocardiographic parameters before resuscitation T1= Echocardiographic parameters 15minutes after resuscitation by IV fluid or Vasopressor (Post-resuscitation)
28-day Mortality
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Septic Shock
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Thymosin Alpha 1 and IgM Levels in Sepsis
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Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
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ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
Sepsis, Septic Shock Hyperdynamic
RecruitingObservational study
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Sepsis
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.
Surat Tongyoo, MD principal investigator
Siriraj Hospital
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 Septic Shock, run by Mahidol University at 1 site in Thailand.
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 3 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: opening soon, as of the sponsor's last update on 27 Feb 2026. 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 Thailand. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Surat Tongyoo, MD (+66824198534, surat.ton@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cardiac Index (time frame: T0 = Cardiac index before resuscitation T1= Cardiac index 15minutes after resuscitation by IV fluid or Vasopressor (Post-resuscitation)). 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 27 Feb 2026.