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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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-511153-21-00
Acronym
NCHGDT
Enrollment
140
Registered
2024-06-11
Start date
2025-11-27
Completion date
Unknown
Last updated
2025-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

elective neurosurgery treating unspecified brain conditions

Brief summary

Incidence of adverse events and reactions according to following Adverse Events of Special Interest (AESI) in both study groups.

Detailed description

Duration of surgery, LOS, ICU LOS, 28-day mortality, descriptive analysis of the incidence of any adverse events and reactions, MAP, HR, SVV, number of episodes of hypotension, number of vasopressor administrations, Hemoglobin, plasma lactate level, 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

Interventions

DRUGIsolyte infuzní roztok
DRUGinfuzní roztok

Sponsors

Fakultni Nemocnice Brno
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Incidence of adverse events and reactions according to following Adverse Events of Special Interest (AESI) in both study groups.

Secondary

MeasureTime frame
Duration of surgery, LOS, ICU LOS, 28-day mortality, descriptive analysis of the incidence of any adverse events and reactions, MAP, HR, SVV, number of episodes of hypotension, number of vasopressor administrations, Hemoglobin, plasma lactate level, 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

Countries

Czechia

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026