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Not yet recruiting NCT07438301

Septic Shock Hemodynamic Respond to Volume Resuscitation Versus Vasopressor Administration

— Observational Septic Shock

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Echocardiogram.
Who it may be relevant to
Registry conditions: Septic Shock. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Thailand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Echocardiographic Assessment the Different of Septic Shock Resuscitation: Comparison of Volume Expansion Versus Vasopressor Administration

Overview

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.

Interventions

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

Primary outcome measures

  • Change in Cardiac Index [Time frame: T0 = Cardiac index before resuscitation T1= Cardiac index 15minutes after resuscitation by IV fluid or Vasopressor (Post-resuscitation)]
Secondary outcome measures (2)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Thailand · 1 center
  • Siriraj Hospital — Bangkok

Identifiers

NCT: NCT07438301 · SI 061/2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗