NCT05336357: GENIUS

Non-invasive Goal-directed thErapy oN cIrcUlatory Shock

Recruiting now NA Last updated 26 August 2024

What this trial tests

NA trial testing Goal-Directed Therapy in Hemodynamics Instability in 380 participants. Currently enrolling.

Timeline

20 February 2024

Primary endpoint
22 February 2026

30 October 2026

Quick facts

Lead sponsor	University of Sao Paulo
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	380
Start date	20 February 2024
Primary completion	22 February 2026
Estimated completion	30 October 2026
Sites	1 location across Brazil

Drugs / interventions tested

• Goal-Directed Therapy

Conditions studied

• Hemodynamics Instability — all drugs for Hemodynamics Instability →

Sponsor

University of Sao Paulo

Who can join

18 and older, any sex, with Hemodynamics Instability. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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..

Publications & conference data

No peer-reviewed publications indexed yet for this trial.