Use of dexamethasone in treatment of cerebral edema associated with brain tumors.
J H GALICICH, L A FRENCH, J C MELBY
https://pubmed.ncbi.nlm.nih.gov/13703072Actively Recruiting
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2025-07-09
50
Participants Needed
4
Research Sites
52 weeks
Total Duration
Glioblastoma (GBM) is a common and aggressive brain tumor in adults with a poor outlook despite intensive treatment. Steroids like dexamethasone (DEX) are commonly used throughout GBM care to reduce brain swelling and manage symptoms, but they may cause serious side effects that could negatively impact patient survival. This trial aims to evaluate if selected GBM patients can be safely managed with a restrictive use of DEX, limiting steroid exposure from referral to the neurosurgical center until discharge. Participants will follow a restrictive DEX regimen, where steroids are stopped immediately after study inclusion unless specific failure criteria occur. These criteria include worsening neurological status or increased brain swelling requiring surgical intervention. If these signs appear, DEX treatment will be started. The study observes patients from referral through their hospital discharge, with optional single-dose DEX during surgery if necessary. Throughout the study, patients receive clinical monitoring to track neurological function and brain imaging to assess tumor and edema volumes. Outcomes include the rate of failure of the restrictive regimen within 30 days after surgery, neurological or systemic complications, steroid dosage, and timing of additional treatments. The study also evaluates brain swelling and tumor size changes before and after surgery, along with the need for reoperations. Participants are followed closely to understand the safety and effects of limiting steroid use in GBM care.
CONDITIONS
Restrictive Use of Dexamethasone in Glioblastoma
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From referral to neurosurgical center until discharge
Participants follow a restrictive dexamethasone (DEX) regimen from referral to the neurosurgical center until discharge. Steroids are stopped immediately after study inclusion unless a failure criterion occurs, at which point DEX treatment is initiated.
Clinical follow-up visits until discharge
Total: 4 locations
1
Kantonsspital St. Gallen
Sankt Gallen, St.Gallen, Switzerland, 9007
Not Yet Recruiting
2
Universitätsspital Basel
Basel, Switzerland, 4031
Not Yet Recruiting
3
Department of Neurosurgery
Bern, Switzerland, 3010
Actively Recruiting
4
Universitätsspital Zürich
Zurich, Switzerland, 8091
Not Yet Recruiting
J
Johannes Goldberg, MD
N
Nicole Söll, CDM
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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J H GALICICH, L A FRENCH, J C MELBY
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