Septic Shock Hemodynamic Respond to Volume Resuscitation Versus Vasopressor Administration (ECHO-VEVA)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Septic Shock
• Intervention / Treatment: Diagnostic test: Echocardiogram

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 Type: Observational
• Enrollment (Estimated): 180

Contacts and Locations

• Study Contact: Name: Surat Tongyoo, MD; Phone Number: +66824198534; Email: surat.ton@mahidol.ac.th

Study Locations

• Thailand
  • Bangkok, Thailand, 10700
    • Siriraj Hospital
    • Contact: Thitibud Treerasoradaj, MD; Phone Number: +66858494244; Email: thitibud.tre@mahidol.ac.th

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult critically ill patients whom admitted to either medical or surgical intensive care units (MICU, SICU) at Siriraj Hospital

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Fluid Resuscitation; Patient received fluid resuscitation	Diagnostic test: Echocardiogram; Patient will be undergone echocardiogram for hemodynamic evaluation, before and after resuscitation by fluid and by vasopressor
Vasopressor Resuscitation; Patient received vasopressor titration	Diagnostic test: Echocardiogram; Patient will be undergone echocardiogram for hemodynamic evaluation, before and after resuscitation by fluid and by vasopressor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	T0 = Cardiac index before resuscitation T1= Cardiac index 15minutes after resuscitation by IV fluid or Vasopressor (Post-resuscitation)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	T0 = Echocardiographic parameters before resuscitation T1= Echocardiographic parameters 15minutes after resuscitation by IV fluid or Vasopressor (Post-resuscitation)
28-day Mortality	death outcome	28 days

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Surat Tongyoo, MD, Siriraj Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2028

Study Registration Dates

• First Submitted: May 25, 2025
• First Submitted That Met QC Criteria: February 22, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 22, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: septic shock; sepsis; echocardiogram; hemodynamic
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Pathological Conditions, Signs and Symptoms; Sepsis; Shock, Septic; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Diagnostic Techniques, Cardiovascular; Heart Function Tests; Cardiac Imaging Techniques; Ultrasonography; Echocardiography
• Other Study ID Numbers: SI 061/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No