Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05336357

Non-invasive Goal-directed thErapy oN cIrcUlatory Shock

Led by University of Sao Paulo · Updated on 2024-08-26

380

Participants Needed

1

Research Sites

140 weeks

Total Duration

On this page

Sponsors

U

University of Sao Paulo

Lead Sponsor

I

Instituto Dante Pazzanese de Cardiologia

Collaborating Sponsor

AI-Summary

What this Trial Is About

Circulatory shock occurs when the oxygen supply to the tissues decreases, leading to cellular damage and affecting about one-third of patients admitted to Intensive Care Units (ICUs). Cardiac Output (CO) is defined as the volume of blood ejected by the left ventricle per minute and is a crucial hemodynamic parameter for monitoring patients with signs of circulatory shock. However, this parameter is underutilized in patients treated in Emergency Units because its measurement typically involves invasive methods, which are not commonly available in this setting. Any method capable of measuring CO without the need for pulmonary artery catheter insertion is referred to as minimally invasive CO monitoring. Evaluating these parameters allows for a quicker determination of the etiology of circulatory shock, enabling the early initiation of goal-directed therapy. Goal-directed therapy has been proven effective in reducing morbidity and mortality, ICU length of stay, and mechanical ventilation duration in ICU patients who respond to fluid resuscitation. Currently, there are no data on the impact of a hemodynamic optimization strategy in patients during the early hours of shock. The objective is to assess whether goal-directed hemodynamic therapy, through non-invasive hemodynamic monitoring, reduces the time required for hemodynamic resuscitation in patients with septic shock. A multicenter, randomized, open-label study will be conducted in Emergency Units, Intensive Care Units, and Hospital Wards. Patients over 18 years old admitted with signs of septic shock (defined as systolic blood pressure less than 90 mmHg and/or mean arterial pressure less than 65 mmHg, along with at least one of the following criteria: lactate greater than 2 mEq/L, oliguria, neurological alteration, or capillary refill time greater than 3 seconds) will be included Participants will be randomized in a 1:1 ratio into two groups. In the Goal-Directed Therapy Group, patients will be monitored using the HemoSphere HPI™ (Edwards Life Sciences, Irvine, CA, USA), where parameters such as cardiac index (CI), stroke volume (SV), systolic blood pressure (SBP), mean arterial pressure (MAP), and HPI will guide medical management. In the Conventional Therapy Group, patients will be evaluated with the standard hemodynamic monitoring equipment typically found in emergency units..

CONDITIONS

Official Title

Non-invasive Goal-directed thErapy oN cIrcUlatory Shock

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age greater than 18 years
  • Patients admitted to Emergency Units, Intensive Care Units, and Wards within 3 hours of septic shock diagnosis
  • Systolic Blood Pressure less than 90 mmHg and/or Mean Arterial Pressure less than 65 mmHg (with or without norepinephrine less than 0.5 mcg/kg/min)
  • Clinical signs of infection and at least one of the following: lactate greater than 2 mEq/L, oliguria (urine output less than 0.5 mL/kg/h for at least 6 hours), neurological changes (mental confusion, decreased consciousness, agitation, disorientation), capillary refill time greater than 3 seconds, or poor skin perfusion
  • Signed Informed Consent Form
Not Eligible

You will not qualify if you...

  • Hospital admission time greater than 24 hours
  • Significant edema in the fingers
  • Severe peripheral vasoconstriction
  • Use of norepinephrine at a dose greater than or equal to 0.5 mcg/kg/min
  • Presence of significant aortic insufficiency
  • Patients undergoing renal replacement therapy
  • Patients with ST-segment elevation myocardial infarction
  • Patients requiring invasive mechanical ventilation
  • Patients already participating in another study

AI-Screening

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Trial Site Locations

Total: 1 location

1

Instituto do Coração

São Paulo, Brazil, 05403-000

Actively Recruiting

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Research Team

L

Ludhmila A Hajjar, MD, PhD

CONTACT

A

ARO F InCor, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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