CompletedNot Applicable

Effects of Intraoperative GDFT on the Postoperative Brain Edema

China480 participantsStarted 2018-11-26

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

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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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Quantitative analysis of brain edema

Timeframe: Within 24 hours postoperatively

Trial details

NCT IDNCT03323580

SponsorBeijing Tiantan Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-21

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