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

NCT03831997 | Unknown DMC FDA Drug

• 1 other identifier: #2589
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Recurrence Rate

  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 Outcomes (1)

• Rate of Volume Change of Residual CSDH Space

  24 (+/- 6 hours) hours post-operative.

Study Arms (2)

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%

Interventions

Dextrose 5% W/ Sodium Chloride 0.225% DRUG

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.

Also known as: D5 1/4NS

Prospective Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Sponsors & Collaborators

• Carilion Clinic: lead

Study Sites (1)

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, 24016, United States

RECRUITING

Related Publications (20)

• Alvis-Miranda HR, Castellar-Leones SM, Moscote-Salazar LR. Intravenous Fluid Therapy in Traumatic Brain Injury and Decompressive Craniectomy. Bull Emerg Trauma. 2014 Jan;2(1):3-14.

  PMID: 27162857 BACKGROUND

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  PMID: 23874740 BACKGROUND

• Dickerson RN, Maish GO 3rd, Weinberg JA, Croce MA, Minard G, Brown RO. Safety and efficacy of intravenous hypotonic 0.225% sodium chloride infusion for the treatment of hypernatremia in critically ill patients. Nutr Clin Pract. 2013 Jun;28(3):400-8. doi: 10.1177/0884533613483840. Epub 2013 Apr 22.

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• Komotar RJ, Starke RM, Connolly ES. The role of drain placement following chronic subdural hematoma evacuation. Neurosurgery. 2010 Feb;66(2):N15-6. doi: 10.1227/01.neu.0000367840.82764.3a. No abstract available.

  PMID: 20087120 BACKGROUND

• Matsumoto H, Hanayama H, Okada T, Sakurai Y, Minami H, Masuda A, Tominaga S, Miyaji K, Yamaura I, Yoshida Y. Which surgical procedure is effective for refractory chronic subdural hematoma? Analysis of our surgical procedures and literature review. J Clin Neurosci. 2018 Mar;49:40-47. doi: 10.1016/j.jocn.2017.11.009. Epub 2017 Dec 20.

  PMID: 29274740 BACKGROUND

• Montano N, Stifano V, Skrap B, Mazzucchi E. Management of residual subdural hematoma after burr-hole evacuation. The role of fluid therapy and review of the literature. J Clin Neurosci. 2017 Dec;46:26-29. doi: 10.1016/j.jocn.2017.08.041. Epub 2017 Sep 5.

  PMID: 28887078 BACKGROUND

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MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Interventions

Glucose

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Eric Marvin, DO

  Carilion Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric A Marvin, DO

CONTACT

5405889711; eamarvin@carilionclinic.org

Ayesha Kar, BS

CONTACT

9082080082; akar@carilionclinic.org

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: February 6, 2019
• Study Start: January 17, 2019
• Primary Completion: January 1, 2022
• Study Completion: June 1, 2022
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)