Effects of Intraoperative GDFT on the Postoperative Brain Edema

Not Applicable

Completed

• Conditions: Brain Edema; Fluid Therapy; Brain Tumor
• Interventions: Other: GDFT; Other: traditional fluid therapy

• Registration Number: NCT03323580
• Lead Sponsor: Beijing Tiantan Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-24
• Study First Submitted QC: 2017-10-24
• Study First Posted: 2017-10-27
• Study Start: 2018-11-26
• Primary Completion: 2022-09-21
• Study Completion: 2022-10-31
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-22
• Last Update Posted: 2023-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 480

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GDFT group	GDFT	The patients will receive fluid therapy under goal directed.
Routine group	traditional fluid therapy	The patients will receive routine fluid therapy.

Primary Outcome Measures

Name	Time	Method
Quantitative analysis of brain edema	Within 24 hours postoperatively	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.

Secondary Outcome Measures

Name	Time	Method
The incidence of delirium	During the first 3 postoperative days	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.

Trial Locations

Locations (1)

Beijing Tiantan Hospital; 🇨🇳 Beijing, Beijing, China