Goal-directed Therapy in Neurosurgery.

NCT ID: NCT04754295

Last Updated: 2022-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2021-11-30

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.

Conditions

Surgery--Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

STANDARD

In this arm standard monitoring of vital signs will be used during operation.

Group Type: EXPERIMENTAL

STANDARD

Intervention Type: OTHER

Administration of fluids and vasoactive drugs guided by standard vital signs monitoring

GDT

A non-invasive hemodynamic monitor STARLINK™SV will be used in addition to standard monitoring.

Group Type: EXPERIMENTAL

Goal-Directed Therapy

Intervention Type: OTHER

Administration of fluids and vasoactive drugs guided by non-invasive haemodynamic monitoring

Interventions

Goal-Directed Therapy

Administration of fluids and vasoactive drugs guided by non-invasive haemodynamic monitoring

Intervention Type: OTHER

STANDARD

Administration of fluids and vasoactive drugs guided by standard vital signs monitoring

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brno University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ondrej Hrdy

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roman Gal, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Masaryk University Brno and University Hospital

Locations

University Hospital Brno

Brno, , Czechia

Countries

Czechia

References

Hrdy O, Duba M, Dolezelova A, Roskova I, Hlavaty M, Traj R, Bonisch V, Smrcka M, Gal R. Effects of goal-directed fluid management guided by a non-invasive device on the incidence of postoperative complications in neurosurgery: a pilot and feasibility randomized controlled trial. Perioper Med (Lond). 2023 Jul 5;12(1):32. doi: 10.1186/s13741-023-00321-3.

Reference Type: DERIVED

PMID: 37408018 (View on PubMed)

Other Identifiers

CT0012021

Identifier Type: -

Identifier Source: org_study_id