Non-invasive therapy for circulatory shock management
The Effect of Non-invasive Hemodynamic Goal-directed Therapy on the Incidence of Acute Kidney Injury in Circulatory Shock: a Randomized Clinical Trial
This study tests a new way to monitor heart function in patients with septic shock to see if it helps doctors start treatment faster and improve recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 380 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Sao Paulo Academic / other |
| Locations | 1 site (São Paulo) |
| Trial ID | NCT05336357 on ClinicalTrials.gov |
What this trial studies
This study focuses on patients experiencing circulatory shock, particularly those with septic shock, which is characterized by severe hemodynamic instability. It aims to utilize minimally invasive methods to monitor cardiac output, allowing for quicker diagnosis and initiation of goal-directed therapy. By measuring hemodynamic parameters without invasive techniques, the study seeks to improve patient outcomes in emergency and intensive care settings. The goal is to reduce morbidity and mortality associated with septic shock through timely and effective treatment.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old who are admitted to emergency or intensive care units within 3 hours of septic shock diagnosis.
Not a fit: Patients who have been hospitalized for more than 24 hours or those with severe peripheral vasoconstriction may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates and recovery times for patients suffering from circulatory shock.
How similar studies have performed: Other studies have shown promise in using minimally invasive monitoring techniques for hemodynamic assessment, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
São Paulo
- Instituto do Coração — São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Ludhmila A Hajjar, MD, PhD — University of Sao Paulo
- Study coordinator: Ludhmila A Hajjar, MD, PhD
- Email: ludhmila@usp.br
- Phone: +55 11 26615795
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.