Clinical trial NCT04754295: Goal-directed Therapy in Neurosurgery.
Official title: Effect of Goal-directed Fluid Management Guided by Non-invasive Device on Incidence of Postoperative Complications in Neurosurgery: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery--Complications
Keywords: Neurosurgery
Goal-Directed Therapy
Complications
Pilot study
Lead sponsor: Brno University Hospital
Sponsor class: OTHER
First posted: 2021-02-15
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess feasibility of future large randomised controled study aimed on assessment of effect of goal-directed therapy on incidence of complications in neurosurgery compared to standard care.

Detailed description: Patients undergoing neurosurgical operations are at risk of inadequate intravascular volume for several reasons. The appropriate fluid management in neurosurgery is a challenge. Goal-directed therapy has been shown to improve the outcome of patients undergoing major surgery. Current knowledge regarding effect of fluid management on patient-orientated outcomes in neurosurgery is limited.

This study is designed as a pilot study with two parallel groups. Patients scheduled to planned brain surgery at the University Hospital Brno will be screened whether they meet the inclusion criteria. After obtaining informed consent, the patient will be randomized to one of the study arms.

In one arm (STANDARD) standard monitoring of vital signs will be introduced. During the operation, perioperative fluid therapy and administration of vasoactive agents will depend entirely at the discretion of the attending anaesthetist. Postoperative therapy will be fully controlled and will depend on the decision of the attending physician. In the second arm (GDT), a non-invasive hemodynamic monitor STARLINK™SV will be introduced in addition to standard monitoring. In this arm, basal infusion with crystalloid balanced solution will be initiated. Additional boluses of fluids will be administered based on haemodynamic monitoring. The primary outcome of the study is a proportion of patients with serious adverse event (SAE). Incidence of SAEs will be compared between study groups. SAE will be defined as unsatisfactory brain tissue relaxation at the end of operation and any intervention for brain oedema postoperatively.

The secondary outcome is to compare proportion of patients with postoperative complications in both groups and length of ICU and hospital stay.

This study will enroll 34 patients in total, 17 in each group. After completion of enrolment of patients the statistical analysis will be performed.

Eligibility criteria: Inclusion Criteria:

* age at least 18 years
* anticipated duration of surgery at least 2 hours
* signed written consent form
* American Society of Anesthesiologists (ASA) classification \< 4.

Exclusion Criteria:

* unavailability of hemodynamic monitor
* emergency operation
* ASA ≥4
* sitting operating position and awake craniotomy
* awake craniotomy
* serious cardiorespiratory disorder
* cardiac arrythmia
* obesity with BMI above 35 kg/m2

Primary outcomes:
measure: Serious Adverse Events 1
timeFrame: During the Surgery
measure: Serious Adverse Events 2
timeFrame: 24 hours postoperatively
measure: Recruitment rate
timeFrame: through study completion, an average of 6 months
measure: Completeness of Case Report Forms
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: Complications
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: University Hospital Brno
Study officials:
affiliation: Masaryk University Brno and University Hospital
name: Roman Gal, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: