Effects of Intraoperative GDFT on the Postoperative Brain Edema

Capital Medical University

Status: Completed

Conditions: Fluid Therapy; Brain Edema; Brain Tumor

Treatments: Other: traditional fluid therapy; Other: GDFT

Study type: Interventional

Funder types: Other

Identifiers

NCT03323580

2017-10-24

Details and patient eligibility

About

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.

Enrollment: 480 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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480 participants in 2 patient groups

GDFT group

Experimental group

Description:

The patients will receive fluid therapy under goal directed.

Treatment:

Other: GDFT

Routine group

Sham Comparator group

Description:

The patients will receive routine fluid therapy.

Treatment:

Other: traditional fluid therapy