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Completed

NCT Number: NCT03323580

Effects of Intraoperative GDFT on the Postoperative Brain Edema

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.

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Key information

Conditions

Fluid Therapy Brain Diseases Brain Edema Brain Neoplasms Brain Tumor Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100050, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  1. The incidence of delirium

    Time frame: During the first 3 postoperative days

    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.

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Oct 27, 2017
Registry last updated
Mar 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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