Goal-directed Therapy in Neurosurgery.

NCT04754295 | Completed DMC

• 1 other identifier: CT0012021
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery--Complications

Keywords

Neurosurgery; Goal-Directed Therapy; Complications; Pilot study

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Complications

  through study completion, an average of 6 months

Study Arms (2)

STANDARD

EXPERIMENTAL

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

Other: STANDARD

GDT

EXPERIMENTAL

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

Other: Goal-Directed Therapy

Interventions

Goal-Directed Therapy OTHER

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

GDT

STANDARD OTHER

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

STANDARD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brno University Hospital: lead

Study Sites (1)

University Hospital Brno

Brno, 625 00, Czechia

Location

Related Publications (1)

• 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.

  PMID: 37408018 DERIVED

MeSH Terms

Interventions

Early Goal-Directed Therapy

Intervention Hierarchy (Ancestors)

Critical Care; Patient Care; Therapeutics

Study Officials

• Roman Gal, M.D., Ph.D.

  Masaryk University Brno and University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 15, 2021
• Study Start: March 1, 2021
• Primary Completion: October 31, 2021
• Study Completion: November 30, 2021
• Last Updated: May 4, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)