Goal-directed Therapy in Neurosurgery.

Effect of Goal-directed Fluid Management Guided by Non-invasive Device on Incidence of Postoperative Complications in Neurosurgery: Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Surgery--Complications
• Intervention / Treatment: Other: STANDARD; Other: Goal-Directed Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Brno, Czechia, 625 00
    • University Hospital Brno

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: STANDARD; In this arm standard monitoring of vital signs will be used during operation.	Other: STANDARD; Administration of fluids and vasoactive drugs guided by standard vital signs monitoring
Experimental: GDT; A non-invasive hemodynamic monitor STARLINK™SV will be used in addition to standard monitoring.	Other: Goal-Directed Therapy; Administration of fluids and vasoactive drugs guided by non-invasive haemodynamic monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serious Adverse Events 1	Assessment of number of patients with serious adverse event (SAE). SAE is defined as unsatisfactory brain tissue relaxation at the end of surgery assessed by neurosurgeon. Level 3 or 4 of brain tissue relaxation will be considered as unsatisfactory (level 1 - completely relaxed, level 2 - satisfactorily relaxed, level 3 - firm, level 4 - bulging).	During the Surgery
Serious Adverse Events 2	Assessment of number of patients with serious adverse event (SAE). SAE is defined as any intervention indicated for treatment of brain edema 24 hours after surgery.	24 hours postoperatively
Recruitment rate	Proportion of eligible patients who consent to participate in the study.	through study completion, an average of 6 months
Completeness of Case Report Forms	Proportion of enrolled patients with completed Case Report Form.	through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Number of patients with pre-defined postoperative complication.	through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: Brno University Hospital
• Investigators: Principal Investigator: Roman Gal, M.D., Ph.D., Masaryk University Brno and University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): October 31, 2021
• Study Completion (Actual): November 30, 2021

Study Registration Dates

• First Submitted: February 2, 2021
• First Submitted That Met QC Criteria: February 11, 2021
• First Posted (Actual): February 15, 2021

Study Record Updates

• Last Update Posted (Actual): May 4, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Complications; Pilot study; Neurosurgery; Goal-Directed Therapy
• Other Study ID Numbers: CT0012021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No