Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence

Chronic Subdural Hematoma Clinical Trial

Official title: The Effect of Dextrose 5% in 0.225% Sodium Chloride (D5 1/4NS) on Postoperative Chronic Subdural Hematoma Size and Recurrence Rate

Status Recruiting

Clinical Trial Summary

This study aims to reduce the recurrence rate of chronic subdural hematomas (CSDH) by manipulating the post-operative intravenous fluid use. The hypothesis relies on the relationship between osmolality and volume changes related to osmolality. We will be administering dextrose 5% in 1/4 normal saline (D5 1/4NS) post-operatively to induce brain expansion which can take up the residual CSDH space, to help reduce recurrence rate.

Clinical Trial Description

Chronic subdural hematoma (CSDH) is a neurological disease characterized by a collection of fluid, blood, and blood degradation matter between the arachnoid and dura mater in a well-developed membrane cavity. The presentation of this disease begins with minor head trauma and takes 4-7 weeks to become symptomatic.

One of the significant problems exists with CSDH is the rate of recurrence, which currently stands at a 7-30% rate worldwide. The recurrence of a CSDH is typically defined as the presence of residual or recurrent CSDH after the first resolution, leading to additional surgical intervention either within 3 months (early recurrence) or after 3 months (late recurrence). Additional surgical intervention (recurrence rate) is the outcome variable that our study will be looking at. Factors leading to persistent recurrence include age, use of anticoagulant therapy, volume of hematoma cavity, degree of midline shift on CT, presence of residual air post-operatively, and volume of residual hematoma fluid. The variability in surgeons' operative and post-operative care, which tries to address the multiple factors that lead to recurrence, illustrates the difficulty in trying to reduce postoperative recurrence. In fact, there is no postoperative standard of care. These variations in operative and postoperative care have yet to significantly decrease the recurrent rate of CSDH.

Given the health status and fragility of the patient population that is most commonly affected by CSDHs, and the inherent morbidity related to operating on this population, we hypothesize that D5 1/4NS can help mitigate the issue of residual/recurrence CSDH leading to subsequent surgeries. The fluid dynamics of D5 1/4NS have been studied and we can assume that it will facilitate brain re-expansion. ;

Related Conditions & MeSH terms

• Chronic Subdural Hematoma
• Hematoma
• Hematoma, Subdural, Chronic
• Recurrence

• NCT number: NCT03831997
• Study type: Observational
• Source: Carilion Clinic
• Contact: Eric A Marvin, DO
• Phone: 5405889711
• Email: eamarvin@carilionclinic.org
• Status: Recruiting
• Start date: January 17, 2019
• Completion date: June 1, 2022