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

Status unconfirmed

Conditions studied: Chronic Subdural Hematoma

In brief

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.

Key facts

Study ID

NCT03831997

Run by

Carilion Clinic

People needed

35

Starts

2019-01-17

Expected to finish

2022-06-01

Last updated by the study team

2020-10-08

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• <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

Where it is running

• Carilion Roanoke Memorial Hospital — Roanoke, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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