Effects of Intraoperative GDFT on the Postoperative Brain Edema

Brain Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03323580
• Other study ID #: 2017-10-24
• Status: Completed
• Phase: N/A
• Start date: November 26, 2018
• Est. completion date: October 31, 2022

Study information

• Verified date: March 2023
• Source: Beijing Tiantan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: October 31, 2022
• Est. primary completion date: September 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Edema
• Brain Tumor
• Edema
• Fluid Therapy

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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