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临床试验/NCT03831997
NCT03831997Unknown不适用

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

Carilion Clinic1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2019年1月17日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
35
试验地点
1
主要终点
Recurrence Rate

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • <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

研究组 & 干预措施

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.

干预措施: Dextrose 5% W/ Sodium Chloride 0.225% (Drug)

结局指标

主要结局

Recurrence Rate

时间窗: 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.

次要结局

  • Rate of Volume Change of Residual CSDH Space(24 (+/- 6 hours) hours post-operative.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eric A. Marvin

Principle Investigator

Carilion Clinic

研究点 (1)

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