Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
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| ClinicalTrials.gov Identifier: NCT03831997 |
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Recruitment Status :
Recruiting
First Posted : February 6, 2019
Last Update Posted : October 8, 2020
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| Condition or disease | Intervention/treatment |
|---|---|
| Chronic Subdural Hematoma | Drug: Dextrose 5% W/ Sodium Chloride 0.225% |
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.
| Study Type : | Observational |
| Estimated Enrollment : | 35 participants |
| Observational Model: | Other |
| Time Perspective: | Cross-Sectional |
| Official Title: | The Effect of Dextrose 5% in 0.225% Sodium Chloride (D5 1/4NS) on Postoperative Chronic Subdural Hematoma Size and Recurrence Rate |
| Actual Study Start Date : | January 17, 2019 |
| Estimated Primary Completion Date : | January 1, 2022 |
| Estimated Study Completion Date : | June 1, 2022 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Historical Controls
The retrospective arm will consist of our control group, it will be derived from a retrospective medical chart review of all patients with CSDH at the facility.
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Prospective Arm
The prospective arm of the study will be looking at the effects of Dextrose 5% W/ Sodium Chloride 0.225% on the recurrence rate defined by the need for secondary surgical intervention for residual/recurrent CSDH) of CSDH in a 3-month post-operative window.
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Drug: Dextrose 5% W/ Sodium Chloride 0.225%
D5 1/4NS is comprised of 5% dextrose in a 0.225% sodium chloride (NaCl) solution. D5 1/4NS is initially slightly hypertonic to plasma, with an osmolarity of 321 mOSm/L. As the glucose component is rapidly metabolized, 0.225% NaCl solution remains and is hypotonic to plasma at an osmolarity of 77 mOsm/L. Because of the hypotonicity of the 1/4NS, it shifts into the intracellular compartments, followed by free water, and allows for volume expansion.
Other Name: D5 1/4NS |
- Recurrence Rate [ Time Frame: Within 120 days (+/- 7 days) of their initial burr-hole surgery. ]We will see how many patients who are treated with D5 1/4NS have a recurrent episode of CSDH after their post-operative treatment.
- Rate of Volume Change of Residual CSDH Space [ Time Frame: 24 (+/- 6 hours) hours post-operative. ]We will see how fast the brain volume expands after the administration of both NS and D5 1/4NS.
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03831997
| Contact: Eric A Marvin, DO | 5405889711 | eamarvin@carilionclinic.org | |
| Contact: Ayesha Kar, BS | 9082080082 | akar@carilionclinic.org |
| United States, Virginia | |
| Carilion Roanoke Memorial Hospital | Recruiting |
| Roanoke, Virginia, United States, 24016 | |
| Contact: Eric Marvin, DO 540-588-9711 eamarvin@carilionclinic.org | |
| Contact: Ayesha Kar 9082080082 akar@carilionclinic.org | |
| Principal Investigator: Eric Marvin, DO | |
| Sub-Investigator: Ayesha Kar, BS | |
| Principal Investigator: | Eric Marvin, DO | Carilion Clinic |
| Responsible Party: | Eric A. Marvin, Principle Investigator, Carilion Clinic |
| ClinicalTrials.gov Identifier: | NCT03831997 |
| Other Study ID Numbers: |
#2589 |
| First Posted: | February 6, 2019 Key Record Dates |
| Last Update Posted: | October 8, 2020 |
| Last Verified: | October 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | Yes |
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Hematoma, Subdural Hematoma, Subdural, Chronic Recurrence Hematoma Disease Attributes Pathologic Processes Hemorrhage Intracranial Hemorrhage, Traumatic Intracranial Hemorrhages |
Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Vascular Diseases Cardiovascular Diseases Wounds and Injuries |