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Clinical Trials/NCT03323580
NCT03323580
Completed
Not Applicable

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

Beijing Tiantan Hospital1 site in 1 country480 target enrollmentNovember 26, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fluid Therapy
Sponsor
Beijing Tiantan Hospital
Enrollment
480
Locations
1
Primary Endpoint
Quantitative analysis of brain edema
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 26, 2018
End Date
October 31, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Beijing Tiantan Hospital
Responsible Party
Principal Investigator
Principal Investigator

Yuming Peng

Ph.D.,M.D.

Beijing Tiantan Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Quantitative analysis of brain edema

Time Frame: 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 Outcomes

  • The incidence of delirium(During the first 3 postoperative days)

Study Sites (1)

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