Septic Shock Hemodynamic Respond to Volume Resuscitation Versus Vasopressor Administration

NCT07438301 | Not Yet Recruiting DMC

• 1 other identifier: SI 061/2024
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Septic Shock

Keywords

sepsis; septic shock; hemodynamic; echocardiogram

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change of other echocardiographic parameter from baseline to post-resuscitation.

  T0 = Echocardiographic parameters before resuscitation T1= Echocardiographic parameters 15minutes after resuscitation by IV fluid or Vasopressor (Post-resuscitation)

• 28-day Mortality

  28 days

Study Arms (2)

Fluid Resuscitation

Patient received fluid resuscitation

Diagnostic Test: Echocardiogram

Vasopressor Resuscitation

Patient received vasopressor titration

Diagnostic Test: Echocardiogram

Interventions

Echocardiogram DIAGNOSTIC_TEST

Patient will be undergone echocardiogram for hemodynamic evaluation, before and after resuscitation by fluid and by vasopressor

Fluid Resuscitation; Vasopressor Resuscitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Siriraj Hospital

Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Shock, Septic; Sepsis

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Surat Tongyoo, MD

  Siriraj Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Surat Tongyoo, MD

CONTACT

+66824198534; surat.ton@mahidol.ac.th

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2025
• First Posted: February 27, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

TH (1)