Status:
RECRUITING
Non-invasive Goal-directed thErapy oN cIrcUlatory Shock
Lead Sponsor:
University of Sao Paulo
Collaborating Sponsors:
Instituto Dante Pazzanese de Cardiologia
Conditions:
Hemodynamics Instability
Eligibility:
All Genders
18+ years
Phase:
NA
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 (...
Detailed Description
Introduction: Sepsis is a severe condition where the body responds inadequately to an infection. Septic shock is a subset of sepsis characterized by significantly increased mortality due to severe cir...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2026
Estimated Enrollment :
380 Patients enrolled
Trial Details
Trial ID
NCT05336357
Start Date
February 20 2024
End Date
October 30 2026
Last Update
August 26 2024
Active Locations (1)
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1
Instituto do Coração
São Paulo, Brazil, 05403-000