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Septic Shock Hemodynamic Respond to Volume Resuscitation Versus Vasopressor Administration

ConditionSeptic Shock
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMahidol University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Echocardiogram

    Diagnostic test

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

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Fluid Resuscitation1 intervention
Group B: Vasopressor Resuscitation1 intervention

Trial outcomes

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)

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

Secondary outcomes

1

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

Time frame
T0 = Echocardiographic parameters before resuscitation T1= Echocardiographic parameters 15minutes after resuscitation by IV fluid or Vasopressor (Post-resuscitation)
2

28-day Mortality

death outcome

Time frame
28 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mahidol University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: