Recruiting

D5 1/4NS

Sponsor:

Carilion Clinic

Code:

NCT03831997

Conditions

Chronic Subdural Hematoma

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Dextrose 5% W/ Sodium Chloride 0.225%

Study Details

Brief 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.

Conditions

Chronic Subdural Hematoma

Study ID

NCT03831997

Start date

Jan 17, 2019

Status verified date

Oct, 2020

Completion date

Jun 1, 2022

Anticipated

Primary completion date

Jan 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

35 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Recurrence Rate [ Time Frame: Within 120 days (+/- 7 days) of their initial burr-hole surgery. ]

Central Contacts and Locations

Central contacts

Eric A Marvin, DO

5405889711eamarvin@carilionclinic.org

Ayesha Kar, BS

9082080082akar@carilionclinic.org

Locations

Carilion Roanoke Memorial Hospital

Recruiting

Roanoke, Virginia, United States, 24016

Contacts

Eric Marvin, DO

540-588-9711eamarvin@carilionclinic.org

Ayesha Kar

9082080082akar@carilionclinic.org

Principal Investigator:

Eric Marvin, DO

More Information

Sponsor

Carilion Clinic

Last update posted

Oct 8, 2020

Last verified

Oct, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Carilion Clinic on 2020-10-08.