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Recruiting NCT07101991

Effects of GDHT (Goal Directed Hemodynamic Therapy) Using a Non-invasive Hemodynamic Monitoring in Elective Neurosurgery

Conditions: Surgery Complications

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 140
Sponsor: Brno University Hospital

Location: The University Hospital Brno Brno

Summary

This study aims to assess the safety and efficacy of GDHT using the non-invasive Starling™ SV System in elective neurosurgery. The tested group of patients (n=70) will be compared with a control group (n=70), where hemodynamic management will be guided by standard vital signs monitoring.

Eligibility Criteria

Inclusion Criteria: Subjects will be eligible for the trial if they meet all of the following criteria: * Age ≥ 18 years * Elective brain surgery with an expected duration ≥ 2 h * Category 1-3 according to the ASA (American Society of Anesthesiologists) Physical Status Classification * Lateral or supine operative position * Signed the relevant informed consent form Exclusion Criteria: Subjects will not be eligible for the trial if they meet any of the following criteria: * Category 4 according to the ASA Physical Status Classification * Surgery for traumatic brain injury or acute hemorrhagic stroke * Awake brain surgery * Osmotherapy before surgery (with the exception of prophylactic administration of osmotic agents according to institutional standards) * Unavailability of hemodynamic monitoring data * Cardiac arrhythmia with irregular cardiac rhythm * Known hypersensitivity to the active substance or to any of the excipients of IMP (Investigational Medicinal Product) * Pregnancy and lactation

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07101991). StuddyBuddy aggregates publicly available trial information.