Clinical trial NCT03831997: Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Official title: The Effect of Dextrose 5% in 0.225% Sodium Chloride (D5 1/4NS) on Postoperative Chronic Subdural Hematoma Size and Recurrence Rate
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Subdural Hematoma
Lead sponsor: Carilion Clinic
Sponsor class: OTHER
First posted: 2019-02-06
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will be recruiting patients (male, female; 18-60 years old) from our center, Carilion Roanoke Memorial Hospital, that have been diagnosed with CSDH necessitating burr-hole evacuation who fit our inclusion and exclusion criteria.

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of chronic subdural hematoma (based on imaging)
* Need for surgical intervention (assessed by attending neurosurgeon based on full neurological assessment)
* The procedure of choice is burr hole drainage
* Cessation of anti-coagulant therapy with accompanying normal lab values in appropriate time frames respective to the drug
* Tolerance of supine position

Exclusion Criteria:

* \<60 years old
* Presence of acute hemorrhage, stroke, or parenchymal damage
* Neurological deficits not accountable to mass effect
* Hyponatremia or inherent electrolyte imbalances
* Pregnancy or non-consentable patients
* Previous neurological surgery up to 1 year before being considered for the study
* Rapid re-expansion of brain observed intraoperatively by attending neurosurgeon
* Congestive heart failure or other medical conditions precluding normal postoperative administration of IV fluids
* Blood glucose levels \> 135 mg/dL

Primary outcomes:
measure: Recurrence Rate
timeFrame: Within 120 days (+/- 7 days) of their initial burr-hole surgery.
Secondary outcomes:
measure: Rate of Volume Change of Residual CSDH Space
timeFrame: 24 (+/- 6 hours) hours post-operative.
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Carilion Roanoke Memorial Hospital
state: Virginia
Study officials:
affiliation: Carilion Clinic
name: Eric Marvin, DO
role: PRINCIPAL_INVESTIGATOR
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