Effects of Intraoperative GDFT on the Postoperative Brain Edema

NCT03323580 | Completed

• 1 other identifier: 2017-10-24
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

Fluid Therapy; Brain Edema; Brain Tumor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The incidence of delirium

  During the first 3 postoperative days

Study Arms (2)

GDFT group

EXPERIMENTAL

The patients will receive fluid therapy under goal directed.

Other: GDFT

Routine group

SHAM COMPARATOR

The patients will receive routine fluid therapy.

Other: traditional fluid therapy

Interventions

GDFT OTHER

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.

GDFT group

traditional fluid therapy OTHER

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.

Routine group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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-2.
• Awake craniotomy.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100050, China

Location

Related Publications (1)

• Liu X, Zhang X, Fan Y, Li S, Peng Y. Effect of intraoperative goal-directed fluid therapy on the postoperative brain edema in patients undergoing high-grade glioma resections: a study protocol of randomized control trial. Trials. 2022 Nov 19;23(1):950. doi: 10.1186/s13063-022-06859-9.

  PMID: 36401274 DERIVED

MeSH Terms

Conditions

Brain Edema; Brain Neoplasms

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.,M.D.

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: October 27, 2017
• Study Start: November 26, 2018
• Primary Completion: September 21, 2022
• Study Completion: October 31, 2022
• Last Updated: March 24, 2023

Record last verified: 2023-03

Locations

CN (1)