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Effects of goal-directed fluid management guided by a non-invasive device on the incidence of postoperative complications in neurosurgery: a multicenter, prospective, randomized, controlled study
EU CTIS ID: 2024-511153-21-00
What this study is testing
The primary objective of the clinical trial is to determine the effect of GDHT guided by the non-invasive Starling™ SV System on the incidence of postoperative complications in patients undergoing neurosurgical intervention.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years
- Elective brain surgery with an expected duration ≥ 2 h
- Category 1-3 according to the ASA Physical Status Classification
- Lateral or supine operative position
- Signed the relevant informed consent form
You likely can't join if
- 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
See the full eligibility criteria
- Age ≥ 18 years
- Elective brain surgery with an expected duration ≥ 2 h
- Category 1-3 according to the ASA Physical Status Classification
- Lateral or supine operative position
- Signed the relevant informed consent form
- 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
- Pregnancy and lactation
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.