NCT04754295

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Brno University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Goal-Directed Therapy	Administration of fluids and vasoactive drugs guided by non-invasive haemodynamic monitoring
OTHER	STANDARD	Administration of fluids and vasoactive drugs guided by standard vital signs monitoring

Timeline

• Start date: 2021-03-01
• Primary completion: 2021-10-31
• Completion: 2021-11-30
• First posted: 2021-02-15
• Last updated: 2022-05-04

Locations

1 site across 1 country: Czechia