NCT05336357 Non-invasive Goal-directed thErapy oN cIrcUlatory Shock
| NCT ID | NCT05336357 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Sao Paulo |
| Condition | Hemodynamics Instability |
| Study Type | INTERVENTIONAL |
| Enrollment | 380 participants |
| Start Date | 2024-02-20 |
| Primary Completion | 2026-02-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 380 participants in total. It began in 2024-02-20 with a primary completion date of 2026-02-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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..
Eligibility Criteria
Inclusion Criteria * Age \> 18 years; * Patients admitted to Emergency Units, Intensive Care Units, and Wards within 3 hours of the diagnosis of Septic Shock: * Systolic Blood Pressure (SBP) \< 90 mmHg and/or Mean Arterial Pressure (MAP) \< 65 mmHg (with or without norepinephrine at a dose less than 0.5 mcg/kg/min) + Clinical signs of infection and at least one of the following: * Lactate \> 2 mEq/L; * Oliguria (urine output \< 0.5 mL/kg/h for at least 6 hours); * Neurological changes (mental confusion, decreased level of consciousness, psychomotor agitation, temporal-spatial disorientation); * Capillary refill time \> 3 s (after digital compression for 10 seconds); * Poor skin perfusion. * Signed Informed Consent Form. Exclusion Criteria * 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
Contact & Investigator
Ludhmila A Hajjar, MD, PhD
PRINCIPAL INVESTIGATOR
University of Sao Paulo
Frequently Asked Questions
Who can join the NCT05336357 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hemodynamics Instability. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05336357 currently recruiting?
Yes, NCT05336357 is actively recruiting participants. Contact the research team at ludhmila@usp.br for enrollment information.
Where is the NCT05336357 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT05336357 clinical trial?
NCT05336357 is sponsored by University of Sao Paulo. The principal investigator is Ludhmila A Hajjar, MD, PhD at University of Sao Paulo. The trial plans to enroll 380 participants.