Effect of non-invasive hemodynamic monitoring on fluid management in elective brain surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized trial compares standard fluid management based on vital signs with a goal-directed approach guided by a non-invasive hemodynamic monitor (STARLINK SV) in adults undergoing elective brain surgery. Participants are randomized to receive perioperative fluids and vasopressors guided by either traditional monitoring or the STARLINK SV device in addition to standard care. The primary outcome is the rate of adverse events related to perioperative management; secondary outcomes include safety and efficacy measures related to tissue perfusion and recovery. The study targets 140 participants, with equal allocation to each arm, across multiple centers. The trial addresses the limited evidence for goal-directed therapy in neurosurgery and aims to determine if this approach can improve postoperative safety.

Why it matters

Who can join: the full rules

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

Where it's running

• The University Hospital Brno
  Brno, Czechia Recruiting

Study contacts

• Study coordinator: Roman Gál, prof.
• Email: gal.roman@fnbrno.cz
• Phone: +420 532 233 850

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.