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

NCT03831997 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 35

Last updated 2020-10-08

No results posted yet for this 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.

Conditions

  • Chronic Subdural Hematoma

Interventions

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.

Sponsors & Collaborators

  • Carilion Clinic

    lead OTHER

Principal Investigators

  • Eric Marvin, DO · Carilion Clinic

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-17
Primary Completion
2022-01-01
Completion
2022-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03831997 on ClinicalTrials.gov