Effects of Intraoperative GDFT on the Postoperative Brain Edema

Effects of Intraoperative Goal-directed Fluid Therapy (GDFT) on the Postoperative Brain Edema in Neurosurgical Patients With Malignant Supratentorial Gliomas

Whether a fluid protocol aiming for protecting vital organ perfusion or fluid restriction is favorable to post-craniotomy outcomes such as brain edema remains uncertain. To our knowledge, there has been no extensive and quantitative analysis of brain edema following SVV-based GDFT in neurosurgical patients with malignant supratentorial glioma. So the study aims to observe the effect of the stroke volume variation-based GDFT on the postoperative brain edema and decrease the incidence of postoperative complications in neurosurgical patients with malignant supratentorial gliomas.

Study Overview

• Status: Completed
• Conditions: Brain Tumor; Fluid Therapy; Brain Edema
• Intervention / Treatment: Other: GDFT; Other: traditional fluid therapy

• Study Type: Interventional
• Enrollment (Actual): 480
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Beijing Tiantan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Preoperative brain image indicating high-grade glioma (HGG), verified by postoperative histology of the World Health Organization (WHO) as grade III or IV tumors.
2. Age 18-65 years, and American Society of Anaesthesiologists (ASA) physical status I to III.
3. Signed informed consent.

Exclusion Criteria:

1. Renal insufficiency or the creatinine clearance is < 30 mL/kg.
2. Heart disease, New York Heart Association Functional Classification (NYHA) class II or higher heart failure, or if their cardiac ejection fraction is < 20%.
3. Chronic obstructive pulmonary disease.
4. Extensive peripheral arterial occlusive disease.
5. Coagulopathy.
6. Surgery in the prone position.
7. Recurrent carcinoma or tumor in the brain ventricular.
8. Body Mass Index <18.5 kg·m-2 or >30.0 kg·m-2.
9. Awake craniotomy.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GDFT group; The patients will receive fluid therapy under goal directed.	Other: GDFT; Target parameter will be titrated with fluid bolus, and thus individual amount varied depending on the parameter value at that time. Maintenance of oxygenation, hemoglobin, blood glucose, core temperature and hemodynamics, such as mean arterial pressure and heart rate, will be applied according to the same standard for each patient.
Sham Comparator: Routine group; The patients will receive routine fluid therapy.	Other: traditional fluid therapy; Fluid therapy will be done without goal directed. Maintenance of oxygenation, hemoglobin, blood glucose, core temperature and hemodynamics, such as mean arterial pressure and heart rate, will be applied according to the same standard for each patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative analysis of brain edema	Postoperative brain edema is defined as edema surrounding the surgical resection cavity, which will be evaluated through CT images.Image evaluators will manually delineate region of interest (ROI) and operative cavity on each slice. The area will be calculated automatically by PACS system. The total volume will be acquired by multiplying area and slice thickness. The volume of edema will be calculated by the totoal volume of edema plus cavity minus the volume of cavity.	Within 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of delirium	Delirium was assessed twice daily (between 8-10 am and between 6-8 pm) with the Confusion Assessment Method for Intensive Care Unit (CAM-ICU) for critical care patients, or the 3-minute Diagnostic interview for Confusion Assessment Method (3D-CAM) for ward assessments, combined with the Richmond Agitation Sedation Scale (RASS). Delirium assessments were only conducted in patients with RASS sedation score exceeding -4.	During the first 3 postoperative days

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital

Publications and helpful links

General Publications

• Liu X, Zhang X, Fan Y, Li S, Peng Y. Effect of intraoperative goal-directed fluid therapy on the postoperative brain edema in patients undergoing high-grade glioma resections: a study protocol of randomized control trial. Trials. 2022 Nov 19;23(1):950. doi: 10.1186/s13063-022-06859-9.

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2018
• Primary Completion (Actual): September 21, 2022
• Study Completion (Actual): October 31, 2022

Study Registration Dates

• First Submitted: October 24, 2017
• First Submitted That Met QC Criteria: October 24, 2017
• First Posted (Actual): October 27, 2017

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 22, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Edema; Brain Edema
• Other Study ID Numbers: 2017-10-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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