NCT03323580

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 480 (actual)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fluid Therapy
• Brain Edema
• Brain Tumor

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2018-11-26
• Primary completion: 2022-09-21
• Completion: 2022-10-31
• First posted: 2017-10-27
• Last updated: 2023-03-24

Locations

1 site across 1 country: China