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

Chronic Subdural Hematoma Clinical Trial

Official title:

The Effect of Dextrose 5% in 0.225% Sodium Chloride (D5 1/4NS) on Postoperative Chronic Subdural Hematoma Size and Recurrence Rate

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03831997
• Other study ID #: #2589
• Status: Recruiting
• Start date: January 17, 2019
• Est. completion date: June 1, 2022

Study information

• Verified date: October 2020
• Source: Carilion Clinic
• Contact: Eric A Marvin, DO
• Phone: 5405889711
• Email: eamarvin[@]carilionclinic.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: June 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Subdural Hematoma
• Hematoma
• Hematoma, Subdural, Chronic
• Recurrence

Intervention

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.

Locations

Country	Name	City	State
United States	Carilion Roanoke Memorial Hospital	Roanoke	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Carilion Clinic

Country where clinical trial is conducted

United States, 

References & Publications (20)

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Balser D, Farooq S, Mehmood T, Reyes M, Samadani U. Actual and projected incidence rates for chronic subdural hematomas in United States Veterans Administration and civilian populations. J Neurosurg. 2015 Nov;123(5):1209-15. doi: 10.3171/2014.9.JNS141550. Epub 2015 Mar 20. — View Citation

De Bonis P, Trevisi G, de Waure C, Sferrazza A, Volpe M, Pompucci A, Anile C, Mangiola A. Antiplatelet/anticoagulant agents and chronic subdural hematoma in the elderly. PLoS One. 2013 Jul 12;8(7):e68732. doi: 10.1371/journal.pone.0068732. Print 2013. — View Citation

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. — View Citation

Edlmann E, Giorgi-Coll S, Whitfield PC, Carpenter KLH, Hutchinson PJ. Pathophysiology of chronic subdural haematoma: inflammation, angiogenesis and implications for pharmacotherapy. J Neuroinflammation. 2017 May 30;14(1):108. doi: 10.1186/s12974-017-0881-y. Review. — View Citation

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Janowski M, Kunert P. Intravenous fluid administration may improve post-operative course of patients with chronic subdural hematoma: a retrospective study. PLoS One. 2012;7(4):e35634. doi: 10.1371/journal.pone.0035634. Epub 2012 Apr 20. — View Citation

Kirk T, Jones K, Miller S, Corbett J. Measurement of intraocular and intracranial pressure: is there a relationship? Ann Neurol. 2011 Aug;70(2):323-6. doi: 10.1002/ana.22414. Epub 2011 Jun 27. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Motiei-Langroudi R, Stippler M, Shi S, Adeeb N, Gupta R, Griessenauer CJ, Papavassiliou E, Kasper EM, Arle J, Alterman RL, Ogilvy CS, Thomas AJ. Factors predicting reoperation of chronic subdural hematoma following primary surgical evacuation. J Neurosurg. 2018 Nov 1;129(5):1143-1150. doi: 10.3171/2017.6.JNS17130. — View Citation

Oh HJ, Lee KS, Shim JJ, Yoon SM, Yun IG, Bae HG. Postoperative course and recurrence of chronic subdural hematoma. J Korean Neurosurg Soc. 2010 Dec;48(6):518-23. doi: 10.3340/jkns.2010.48.6.518. Epub 2010 Dec 31. — View Citation

Prud'homme M, Mathieu F, Marcotte N, Cottin S. A Pilot Placebo Controlled Randomized Trial of Dexamethasone for Chronic Subdural Hematoma. Can J Neurol Sci. 2016 Mar;43(2):284-90. doi: 10.1017/cjn.2015.393. Epub 2016 Feb 8. — View Citation

Rohde V, Graf G, Hassler W. Complications of burr-hole craniostomy and closed-system drainage for chronic subdural hematomas: a retrospective analysis of 376 patients. Neurosurg Rev. 2002 Mar;25(1-2):89-94. — View Citation

Thotakura AK, Marabathina NR. Nonsurgical Treatment of Chronic Subdural Hematoma with Steroids. World Neurosurg. 2015 Dec;84(6):1968-72. doi: 10.1016/j.wneu.2015.08.044. Epub 2015 Sep 2. — View Citation

Yadav YR, Parihar V, Namdev H, Bajaj J. Chronic subdural hematoma. Asian J Neurosurg. 2016 Oct-Dec;11(4):330-342. Review. — View Citation

Zhang Y, Chen S, Xiao Y, Tang W. Effects of Dexamethasone in the Treatment of Recurrent Chronic Subdural Hematoma. World Neurosurg. 2017 Sep;105:115-121. doi: 10.1016/j.wneu.2017.05.135. Epub 2017 May 31. — View Citation

Zornow MH, Prough DS. Fluid management in patients with traumatic brain injury. New Horiz. 1995 Aug;3(3):488-98. Review. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of Volume Change of Residual CSDH Space	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.