Comparison of invasive and non-invasive measurements of haemodynamic parameters in patients with advanced heart failure.
Mateusz Sokolski, Agnieszka Rydlewska, Bartosz Krakowiak...
https://pubmed.ncbi.nlm.nih.gov/21941196/Actively Recruiting
Led by University of Sao Paulo · Updated on 2024-08-26
380
Participants Needed
1
Research Sites
35 weeks
Total Duration
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
Non-invasive Goal-directed thErapy oN cIrcUlatory Shock
L
Ludhmila A Hajjar, MD, PhD
A
ARO F InCor, MD
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University of Sao Paulo
Lead Sponsor
Instituto Dante Pazzanese de Cardiologia
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 hours
Participants receive either goal-directed therapy with continuous non-invasive hemodynamic monitoring or conventional therapy according to standard emergency care for septic shock during the first 24 hours after randomization.
Continuous monitoring during treatment period
Duration - Up to 6 months
Participants are monitored for health outcomes including kidney injury, myocardial events, length of hospital stay, quality of life, health costs, and mortality over varying time frames up to 6 months after treatment.
Visits at hospital admission, 30 days, and additional assessments up to 6 months
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/31996854/University of Sao Paulo
Lead Sponsor
Instituto Dante Pazzanese de Cardiologia
Collaborating Sponsor