Re-bleeding in Giant Meningioma and Intraoperative Hydroxyethyl Starch (HES) Fluid Therapy
Sponsored by Chiang Mai University
About this trial
Last updated 2 months ago
Study ID
ANE-2568-0034
Status
Completed
Type
Observational
Placebo
No
Accepting
18+ Years
All Sexes
Trial Timing
Ended 3 months ago
What is this trial about?
Project Summary: Retrospective Cohort Study
1. Core ObjectiveThe primary goal is to determine if the volume of Hydroxyethyl Starch (HES) 130/0.4 (specifically Voluven® or Volulyte®) administered during the removal of giant meningiomas (tumors \> 5 cm) increases the risk of postoperative complications.
2. Research Question
Does the volume of intraoperative HES solution influence the rate of re-bleeding (requiring a second surgery within 48 hours) or the development of Acute Kidney Injury (AKI) within 7 days after the initial craniotomy?Outcomes:
3. Outcomes Primary: Incidence of re-bleeding at the tumor bed requiring re-operation within 48 hours Secondary: New-onset postoperative AKI within 7 days (defined by KDIGO criteria)
What are the participation requirements?
Inclusion Criteria
* Inclusion CriteriaTo be included in the study, participants must meet all of the following requirements:Age: Patients must be at least 18 years old.
Diagnosis: Patients must be diagnosed with a meningioma. Tumor Size: The tumor must be classified as "giant," defined as having a diameter of 5 cm or larger as seen on a CT scan.
Surgery Type: Patients must have undergone a craniotomy to remove the tumor. Timeframe: The surgery must have occurred between the years 2016 and 2024
Exclusion Criteria
* Exclusion CriteriaPatients will be excluded from the study if they meet any of the following conditions:
Recurrent Cases: Patients with a recurrent meningioma (rather than a first-time surgery).
Emergency Cases: Patients requiring an emergency craniotomy. Pregnancy: Any patient who is pregnant. Major Complications: Patients who experienced cardiac arrest during the surgery.