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Effects of Intraoperative GDFT on the Postoperative Brain Edema

Primary Purpose

Fluid Therapy, Brain Edema, Brain Tumor

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
GDFT
traditional fluid therapy
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Fluid Therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Beijing Tiantan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

GDFT group

Routine group

Arm Description

The patients will receive fluid therapy under goal directed.

The patients will receive routine fluid therapy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 24, 2017
Last Updated
March 22, 2023
Sponsor
Beijing Tiantan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03323580
Brief Title
Effects of Intraoperative GDFT on the Postoperative Brain Edema
Official Title
Effects of Intraoperative Goal-directed Fluid Therapy (GDFT) on the Postoperative Brain Edema in Neurosurgical Patients With Malignant Supratentorial Gliomas
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 26, 2018 (Actual)
Primary Completion Date
September 21, 2022 (Actual)
Study Completion Date
October 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fluid Therapy, Brain Edema, Brain Tumor

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
480 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GDFT group
Arm Type
Experimental
Arm Description
The patients will receive fluid therapy under goal directed.
Arm Title
Routine group
Arm Type
Sham Comparator
Arm Description
The patients will receive routine fluid therapy.
Intervention Type
Other
Intervention Name(s)
GDFT
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
traditional fluid therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quantitative analysis of brain edema
Description
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.
Time Frame
Within 24 hours postoperatively
Secondary Outcome Measure Information:
Title
The incidence of delirium
Description
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.
Time Frame
During the first 3 postoperative days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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-2. Awake craniotomy.
Facility Information:
Facility Name
Beijing Tiantan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36401274
Citation
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.
Results Reference
derived

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Effects of Intraoperative GDFT on the Postoperative Brain Edema

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