Prognostic Observation of Posterior Reversible Encephalopathy Syndrome

NCT02665598 | Unknown DMC

• 1 other identifier: BoGao
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Posterior Reversible Encephalopathy Syndrome (PRES) is a clinical-radiological entity, which is associated with a variety of clinical conditions. The imaging and clinical findings are typically reversible, but many patients still have permanent neurological sequelae with a fatal outcome. Up to now there are no consistent conclusions about the factors that affecting its prognosis. The objective of our study is to discuss the effects of different causes, different imaging findings and laboratory parameters on the prognosis of PRES and deepen the understanding of the nature of PRES. This will contribute to predict the prognosis of patients with PRES and to further investigate the pathogenesis of PRES so as to guide the clinical treatment and follow-up evaluation. A multi-center retrospective case study will be performed from January 2016 to July 2017 and a total of 400 patients who meet the criteria for PRES diagnosis from 10 sub-centers are anticipated included in this research. Patients will be divided into several subgroups according to the etiology. Date will be collected from the clinical records，imaging and laboratory data of the patients, including demographic data, clinical data, imaging findings, laboratory parameters and follow-up data. During the follow-up, MRI and blood biochemical examination will be performed once more. The imaging findings of the patients will be assessed by two neuroimaging physicians, any difference between them will be agreed upon by consensus. Prognosis of the patients will be assessed by using the modified Rankin scale (mRS) scores. All of the above data is saved into the database. In this study we will review etiologies and imaging findings, laboratory and follow-up data of the patients we selected. Univariate and multivariate analysis will be performed within the group and between groups according to the subgroups. Then we will discuss the connection between different causes, different imaging findings and laboratory parameters and the prognosis of posterior reversible encephalopathy syndrome.

Conditions

Posterior Reversible Encephalopathy Syndrome

Keywords

Posterior Reversible Encephalopathy Syndrome,Prognosis

Outcome Measures

Primary Outcomes (1)

• Quantitative assessment of short term and long term prognosis of PRES patients by mRS score

  within six months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The patients with complete inpatient clinical records who meet the inclusion criteria from January 2016 to July 2015 will be included in this research.

You may qualify if:

• Patients who meet the criteria for PRES diagnosis:(1)typical symptoms and signs consistent with PRES, such as headache, seizures, mental status changes, visual disturbances or focal neurological deficits;(2)patients with typical or atypical imaging manifestations of PRES;(3)patients who have known risk factors of PRES.
• Patients with definite prognosis will be included.
• Patients with complete inpatient medical records will be included.

You may not qualify if:

• Patients with edema secondary to ischemia, hemorrhage, infection, inflammation, or space occupying lesions will be excluded.
• Patients with absent or non-diagnostic MRI will be excluded.

Sponsors & Collaborators

• Yantai Yuhuangding Hospital: lead
• University of Southern California: collaborator

Study Sites (1)

Weihai Municipal Hospital

Weihai, Shandong, 264200, China

RECRUITING

Related Publications (15)

• Alhilali LM, Reynolds AR, Fakhran S. A multi-disciplinary model of risk factors for fatal outcome in posterior reversible encephalopathy syndrome. J Neurol Sci. 2014 Dec 15;347(1-2):59-65. doi: 10.1016/j.jns.2014.09.019. Epub 2014 Sep 22.

  PMID: 25271189 RESULT

• Merayo-Chalico J, Apodaca E, Barrera-Vargas A, Alcocer-Varela J, Colunga-Pedraza I, Gonzalez-Patino A, Arauz A, Abud-Mendoza C, Martinez-Martinez M, Gomez-Martin D. Clinical outcomes and risk factors for posterior reversible encephalopathy syndrome in systemic lupus erythematosus: a multicentric case-control study. J Neurol Neurosurg Psychiatry. 2016 Mar;87(3):287-94. doi: 10.1136/jnnp-2014-310145. Epub 2015 Mar 24.

  PMID: 25804426 RESULT

• Legriel S, Schraub O, Azoulay E, Hantson P, Magalhaes E, Coquet I, Bretonniere C, Gilhodes O, Anguel N, Megarbane B, Benayoun L, Schnell D, Plantefeve G, Charpentier J, Argaud L, Mourvillier B, Galbois A, Chalumeau-Lemoine L, Rivoal M, Durand F, Geffroy A, Simon M, Stoclin A, Pallot JL, Arbelot C, Nyunga M, Lesieur O, Troche G, Bruneel F, Cordoliani YS, Bedos JP, Pico F; Critically III Posterior Reversible Encephalopathy Syndrome Study Group (CYPRESS). Determinants of recovery from severe posterior reversible encephalopathy syndrome. PLoS One. 2012;7(9):e44534. doi: 10.1371/journal.pone.0044534. Epub 2012 Sep 14.

  PMID: 23024751 RESULT

• Liman TG, Bohner G, Endres M, Siebert E. Discharge status and in-hospital mortality in posterior reversible encephalopathy syndrome. Acta Neurol Scand. 2014 Jul;130(1):34-9. doi: 10.1111/ane.12213. Epub 2013 Dec 13.

  PMID: 24329761 RESULT

• Moon SN, Jeon SJ, Choi SS, Song CJ, Chung GH, Yu IK, Kim DH. Can clinical and MRI findings predict the prognosis of variant and classical type of posterior reversible encephalopathy syndrome (PRES)? Acta Radiol. 2013 Dec;54(10):1182-90. doi: 10.1177/0284185113491252. Epub 2013 Jul 15.

  PMID: 23858507 RESULT

• Pande AR, Ando K, Ishikura R, Nagami Y, Takada Y, Wada A, Watanabe Y, Miki Y, Uchino A, Nakao N. Clinicoradiological factors influencing the reversibility of posterior reversible encephalopathy syndrome: a multicenter study. Radiat Med. 2006 Dec;24(10):659-68. doi: 10.1007/s11604-006-0086-2. Epub 2006 Dec 25.

  PMID: 17186320 RESULT

• Pereira PR, Pinho J, Rodrigues M, Rocha J, Sousa F, Amorim J, Ribeiro M, Rocha J, Ferreira C. Clinical, imagiological and etiological spectrum of posterior reversible encephalopathy syndrome. Arq Neuropsiquiatr. 2015 Jan;73(1):36-40. doi: 10.1590/0004-282X20140176. Epub 2015 Jan 1.

  PMID: 25608125 RESULT

• Prasad N, Gulati S, Gupta RK, Kumar R, Sharma K, Sharma RK. Is reversible posterior leukoencephalopathy with severe hypertension completely reversible in all patients? Pediatr Nephrol. 2003 Nov;18(11):1161-6. doi: 10.1007/s00467-003-1243-9. Epub 2003 Sep 19.

  PMID: 14505162 RESULT

• Singh RR, Ozyilmaz N, Waller S, U-King-Im JM, Lim M, Siddiqui A, Sinha MD. A study on clinical and radiological features and outcome in patients with posterior reversible encephalopathy syndrome (PRES). Eur J Pediatr. 2014 Sep;173(9):1225-31. doi: 10.1007/s00431-014-2301-y. Epub 2014 Apr 16.

  PMID: 24737291 RESULT

• Postma IR, Slager S, Kremer HP, de Groot JC, Zeeman GG. Long-term consequences of the posterior reversible encephalopathy syndrome in eclampsia and preeclampsia: a review of the obstetric and nonobstetric literature. Obstet Gynecol Surv. 2014 May;69(5):287-300. doi: 10.1097/OGX.0000000000000069.

  PMID: 25101694 RESULT

• Liman TG, Bohner G, Heuschmann PU, Endres M, Siebert E. The clinical and radiological spectrum of posterior reversible encephalopathy syndrome: the retrospective Berlin PRES study. J Neurol. 2012 Jan;259(1):155-64. doi: 10.1007/s00415-011-6152-4. Epub 2011 Jun 30.

  PMID: 21717193 RESULT

• Fugate JE, Rabinstein AA. Posterior reversible encephalopathy syndrome: clinical and radiological manifestations, pathophysiology, and outstanding questions. Lancet Neurol. 2015 Sep;14(9):914-925. doi: 10.1016/S1474-4422(15)00111-8. Epub 2015 Jul 13.

  PMID: 26184985 RESULT

• Gao B, Liu FL, Zhao B. Association of degree and type of edema in posterior reversible encephalopathy syndrome with serum lactate dehydrogenase level: initial experience. Eur J Radiol. 2012 Oct;81(10):2844-7. doi: 10.1016/j.ejrad.2011.12.010. Epub 2011 Dec 29.

  PMID: 22209526 RESULT

• Gao B, Yu BX, Li RS, Zhang G, Xie HZ, Liu FL, Lv C. Cytotoxic Edema in Posterior Reversible Encephalopathy Syndrome: Correlation of MRI Features with Serum Albumin Levels. AJNR Am J Neuroradiol. 2015 Oct;36(10):1884-9. doi: 10.3174/ajnr.A4379. Epub 2015 Jul 2.

  PMID: 26138140 RESULT

• Bo G, Hui L, Feng-Li L, Cui L. Relationships between edema degree and clinical and biochemical parameters in posterior reversible encephalopathy syndrome: a preliminary study. Acta Neurol Belg. 2012 Sep;112(3):281-5. doi: 10.1007/s13760-012-0060-y. Epub 2012 Mar 24.

  PMID: 22450710 RESULT

MeSH Terms

Conditions

Posterior Leukoencephalopathy Syndrome

Condition Hierarchy (Ancestors)

Hypertensive Encephalopathy; Intracranial Hypertension; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Leukoencephalopathies

Study Officials

• Bo Gao, MD

  STUDY CHAIR

Central Study Contacts

Bo Gao, MD

CONTACT

(626) 223-6910; xiaozugy2015@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2016
• First Posted: January 28, 2016
• Study Start: April 1, 2016
• Primary Completion: July 1, 2023
• Study Completion: January 1, 2024
• Last Updated: August 4, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)