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

Phase 1

Conditions: elective neurosurgery treating unspecified brain conditions
MedDRA version: 20.0Level: PTClassification code: 10067908Term: Neurosurgery Class: 100000004865
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Therapeutic area: Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]

Registration Number: CTIS2024-511153-21-00

Lead Sponsor: Fakultni Nemocnice Brno

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 140

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: To investigate additional safety information, Comparison of hemodynamic characteristics and their changes over time between study groups, Comparison of laboratory values of selected blood parameters and their changes over time between study groups, Comparison of fluid balance and fluid therapy between study groups;Primary end point(s): Incidence of adverse events and reactions according to following Adverse Events of Special Interest (AESI) in both study groups.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Duration of surgery, LOS, ICU LOS, 28-day mortality, descriptive analysis of the incidence of any adverse events and reactions;Secondary end point(s):MAP, HR, SVV, number of episodes of hypotension, number of vasopressor administrations;Secondary end point(s):Hemoglobin, plasma lactate level;Secondary end point(s):Volume of blood loss, urinary output, number of administered units of packed RBC, number of subjects receiving transfusion, crystalloid and colloid solutions consumption, boluses of crystalloids