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ID05336357

Non-invasive Goal-Directed Therapy to Improve Recovery in Adults with Septic Shock Using Hemodynamic Monitoring

Led by University of Sao Paulo · Updated on 2024-08-26

380

Participants Needed

1

Research Sites

35 weeks

Total Duration

AI-Summary

What this Trial Is About

Circulatory shock is a condition where the bodys tissues receive less oxygen, causing cell damage and affecting many patients admitted to Intensive Care Units. This trial focuses on patients with septic shock, a severe form of sepsis with low blood pressure and other critical signs. Researchers are evaluating whether using a non-invasive method to monitor heart function and guide treatment can speed up recovery compared to standard care in emergency and hospital settings. The study is multicenter, randomized, and open-label, involving adult patients over 18 years old. Participants will be divided into two groups. The Goal-Directed Therapy Group will be monitored using the ClearSight System, which continuously measures heart parameters such as cardiac index, stroke volume, and blood pressure for the first 24 hours. Treatment will be adjusted based on these values, including fluid infusions, vasoactive drugs, or inotropic medications as needed. The Conventional Therapy Group will receive usual care with standard monitoring tools, clinical examination, and laboratory tests, following guidelines for fluid resuscitation and medication use. During the study, participants will receive assessments including vital signs, clinical exams, and laboratory tests. Researchers will track how long it takes to achieve hemodynamic resuscitation within 6 hours, as well as other outcomes like kidney injury, heart complications, fluid amounts given, hospital stay length, quality of life, and mortality rates. Follow-up will extend up to 6 months for some outcomes, ensuring comprehensive monitoring of patient progress and safety throughout the trial.

CONDITIONS

Brief Title

Non-invasive Goal-directed thErapy oN cIrcUlatory Shock

Research Team

L

Ludhmila A Hajjar, MD, PhD

A

ARO F InCor, MD

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