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

Last updated: October 6, 2020
Sponsor: Carilion Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT03831997
#2589
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of chronic subdural hematoma (based on imaging)

  • Need for surgical intervention (assessed by attending neurosurgeon based on fullneurological assessment)

  • The procedure of choice is burr hole drainage

  • Cessation of anti-coagulant therapy with accompanying normal lab values in appropriatetime frames respective to the drug

  • Tolerance of supine position

Exclusion

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 postoperativeadministration of IV fluids

  • Blood glucose levels > 135 mg/dL

Study Design

Total Participants: 35
Study Start date:
January 17, 2019
Estimated Completion Date:
June 01, 2022

Study 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.

Connect with a study center

  • Carilion Roanoke Memorial Hospital

    Roanoke, Virginia 24016
    United States

    Active - Recruiting

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