Non-invasive Goal-directed thErapy oN cIrcUlatory Shock
- Conditions
- Hemodynamics Instability
- Registration Number
- NCT05336357
- Lead Sponsor
- University of Sao Paulo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria<br><br> - Age > 18 years;<br><br> - Patients admitted to Emergency Units, Intensive Care Units, and Wards within 3 hours<br> of the diagnosis of Septic Shock:<br><br> - Systolic Blood Pressure (SBP) < 90 mmHg and/or Mean Arterial Pressure (MAP) < 65<br> mmHg (with or without norepinephrine at a dose less than 0.5 mcg/kg/min) + Clinical<br> signs of infection and at least one of the following:<br><br> - Lactate > 2 mEq/L;<br><br> - Oliguria (urine output < 0.5 mL/kg/h for at least 6 hours);<br><br> - Neurological changes (mental confusion, decreased level of consciousness,<br> psychomotor agitation, temporal-spatial disorientation);<br><br> - Capillary refill time > 3 s (after digital compression for 10 seconds);<br><br> - Poor skin perfusion.<br><br> - Signed Informed Consent Form.<br><br>Exclusion Criteria<br><br> - Hospital admission time greater than 24 hours<br><br> - Significant edema in the fingers<br><br> - Severe peripheral vasoconstriction<br><br> - Use of Norepinephrine at a dose greater than or equal to 0.5 mcg/kg/min<br><br> - Presence of significant Aortic Insufficiency<br><br> - Patients undergoing Renal Replacement Therapy<br><br> - Patients with ST-segment elevation Myocardial Infarction<br><br> - Patients requiring Invasive Mechanical Ventilation<br><br> - Patients already participating in another study
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to Resuscitation after 6 hours of treatment
- Secondary Outcome Measures
Name Time Method Number of Participants with Myocardial Injury;Number of Participants with Acute Myocardial Infarction;Patients with Acute Kidney Injury;Assessment of health costs;Length of hospital stay;Amount of fluid administered;Quality of life assessment;Rate of mortality