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

October 6, 2020 updated by: Eric A. Marvin, Carilion Clinic

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Roanoke, Virginia, United States, 24016
        • Recruiting
        • Carilion Roanoke Memorial Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Eric Marvin, DO
        • Sub-Investigator:
          • Ayesha Kar, BS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.
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 Names:
  • D5 1/4NS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 120 days (+/- 7 days) of their initial burr-hole surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 (+/- 6 hours) hours post-operative.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carilion Clinic

Investigators

  • Principal Investigator: Eric Marvin, DO, Carilion Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2019

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

February 4, 2019

First Submitted That Met QC Criteria

February 4, 2019

First Posted (Actual)

February 6, 2019

Study Record Updates

Last Update Posted (Actual)

October 8, 2020

Last Update Submitted That Met QC Criteria

October 6, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #2589

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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