Erilaisten laskimonsisäisten nesteiden vaikutus leikkauksen jälkeiseen krooniseen subduraaliseen hematooman kokoon ja uusiutumiseen
5 % dekstroosin 0,225 % natriumkloridissa (D5 1/4NS) vaikutus leikkauksen jälkeisen kroonisen subduraalisen hematooman kokoon ja uusiutumistiheyteen
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.
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Eric A Marvin, DO
- Puhelinnumero: 5405889711
- Sähköposti: eamarvin@carilionclinic.org
Tutki yhteystietojen varmuuskopiointi
- Nimi: Ayesha Kar, BS
- Puhelinnumero: 9082080082
- Sähköposti: akar@carilionclinic.org
Opiskelupaikat
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Virginia
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Roanoke, Virginia, Yhdysvallat, 24016
- Rekrytointi
- Carilion Roanoke Memorial Hospital
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Ottaa yhteyttä:
- Ayesha Kar
- Puhelinnumero: 9082080082
- Sähköposti: akar@carilionclinic.org
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Päätutkija:
- Eric Marvin, DO
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Alatutkija:
- Ayesha Kar, BS
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Ottaa yhteyttä:
- Eric Marvin, DO
- Puhelinnumero: 5405889711
- Sähköposti: eamarvin@carilionclinic.org
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-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
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.
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Havaintomallit: OTHER
- Aikanäkymät: CROSS_SECTIONAL
Kohortit ja interventiot
Ryhmä/Kohortti |
Interventio / Hoito |
|---|---|
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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. |
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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. |
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.
Muut nimet:
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Recurrence Rate
Aikaikkuna: Within 120 days (+/- 7 days) of their initial burr-hole surgery.
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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.
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Rate of Volume Change of Residual CSDH Space
Aikaikkuna: 24 (+/- 6 hours) hours post-operative.
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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.
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Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Eric Marvin, DO, Carilion Clinic
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- 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.
- 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.
- 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.
- Fedorov A, Beichel R, Kalpathy-Cramer J, Finet J, Fillion-Robin JC, Pujol S, Bauer C, Jennings D, Fennessy F, Sonka M, Buatti J, Aylward S, Miller JV, Pieper S, Kikinis R. 3D Slicer as an image computing platform for the Quantitative Imaging Network. Magn Reson Imaging. 2012 Nov;30(9):1323-41. doi: 10.1016/j.mri.2012.05.001. Epub 2012 Jul 6.
- 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.
- 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.
- 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.
- Feldman Z, Kanter MJ, Robertson CS, Contant CF, Hayes C, Sheinberg MA, Villareal CA, Narayan RK, Grossman RG. Effect of head elevation on intracranial pressure, cerebral perfusion pressure, and cerebral blood flow in head-injured patients. J Neurosurg. 1992 Feb;76(2):207-11. doi: 10.3171/jns.1992.76.2.0207.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. doi: 10.1007/s101430100182.
- 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.
- Yadav YR, Parihar V, Namdev H, Bajaj J. Chronic subdural hematoma. Asian J Neurosurg. 2016 Oct-Dec;11(4):330-342. doi: 10.4103/1793-5482.145102.
- 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.
- Zornow MH, Prough DS. Fluid management in patients with traumatic brain injury. New Horiz. 1995 Aug;3(3):488-98.
- 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. Epub 2017 Dec 15.
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Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Aivoverenkiertohäiriöt
- Aivojen sairaudet
- Keskushermoston sairaudet
- Hermoston sairaudet
- Verisuonisairaudet
- Sydän-ja verisuonitaudit
- Haavat ja vammat
- Patologiset prosessit
- Krooninen sairaus
- Sairauden ominaisuudet
- Verenvuoto
- Kranioaivo-trauma
- Trauma, hermosto
- Intrakraniaaliset verenvuotot
- Intrakraniaalinen verenvuoto, traumaattinen
- Patologiset tilat, merkit ja oireet
- Hematooma, subduraalinen
- Hematooma
- Hematooma, subduraalinen, krooninen
- Hiilihydraatit
- Sokerit
- Heksaosit
- Monosakkaridit
- Glukoosi
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- #2589
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