CTIS2024-511153-21-00
Active, not recruiting
Phase 1
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 - NCHGDT
Fakultni Nemocnice Brno0 sites140 target enrollmentFebruary 22, 2024
Conditionselective neurosurgery treating unspecified brain conditionsMedDRA version: 20.0Level: PTClassification code: 10067908Term: Neurosurgery Class: 100000004865Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Therapeutic area: Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- elective neurosurgery treating unspecified brain conditions
- Sponsor
- Fakultni Nemocnice Brno
- Enrollment
- 140
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion 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
Exclusion 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, Pregnancy and lactation
Outcomes
Primary Outcomes
Not specified
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