Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 3/23/2019 |
| Start Date: | January 17, 2019 |
| End Date: | January 1, 2021 |
| Contact: | Eric A Marvin, DO |
| Email: | eamarvin@carilionclinic.org |
| Phone: | 5405889711 |
The Effect of Dextrose 5% in 0.225% Sodium Chloride (D5 1/4NS) on Postoperative Chronic Subdural Hematoma Size and Recurrence Rate
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.
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.
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.
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.
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
We found this trial at
1
site
Roanoke, Virginia 24033
Principal Investigator: Eric Marvin, DO
Phone: 540-588-9711
Click here to add this to my saved trials
