Optic Nerve Sheath Diameter / Eyeball Transverse Diameter Ratio and Prognosis of Sepsis Associated Encephalopathy

NCT05918705 | Completed

• 1 other identifier: ZU-IRB #10413
• Study Type: observational
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

Sepsis is associated with a mortality rate of 20-25%, with significant increase in case of associated comorbidities or shock. SAE is one of the most common forms of encephalopathy encountered in critically ill patients, with increased ICP as a possible underlying mechanism. Many studies revealed that ONSD is a valuable ICP monitoring tool. Also, ONSD/ETD ratio, according to previous studies, seemed to be more reliable than ONSD alone in predicting neurological outcomes of comatosed patients. The present study will assess the correlation between US-ONSD/ETD ratio and the prognosis of SAE in critically ill patients.

Conditions

Sepsis-associated Encephalopathy

Keywords

Optic nerve sheath diameter; Eyeball transverse diameter; Sepsis-associated encephalopathy

Outcome Measures

Primary Outcomes (1)

• Correlation between US ratio of ONSD/ETD and neurologic outcome 3 months following ICU discharge in critically ill patients with SAE.

  Correlation between US ratio of ONSD/ETD and neurologic outcome 3 months following ICU discharge in critically ill patients with SAE.

  3 months following ICU discharge

Secondary Outcomes (3)

• Correlation between US ratio of ONSD/ETD and neurologic outcome on ICU discharge in critically ill patients with SAE.

  From date of enrolling in the study until the date of discharge from ICU or date of death from any cause, whichever came first, assessed up to 90-days

• Correlation between US ratio of ONSD/ETD and 90-day mortality in critically ill patients with SAE.

  90-days

• Correlation between US ratio of ONSD/ETD and ICU-LOS in critically ill patients with SAE.

  From date of enrolling in the study until the date of discharge from ICU or date of death from any cause, whichever came first, assessed up to 90-days

Study Arms (1)

ONSD / ETD Ratio Correlation With Prognosis of Sepsis Associated Encephalopathy

* Data on in-hospital mortality will be recorded for all patients. * Clinical diagnosis of brain death will be also recorded for all patients. * Morbidity will be assessed both on ICU discharge and 3 months following ICU discharge with the Modified Rankin Scale (mRS), where patients will be assessed at the 3-month follow-up by telephone or face-to-face interviews with the patients or relatives. According to neurologic outcome on ICU discharge and 3 months following ICU discharge, the included patients will be classified into two groups; * Good Neurologic Outcome (GNO); mRS 0 - 2. * Poor Neurologic Outcome (PNO); mRS 3 - 6.

Procedure: Ultrasound optic nerve sheath diameter / eyeball transverse diameter ratio

Interventions

Ultrasound optic nerve sheath diameter / eyeball transverse diameter ratio PROCEDURE

Ocular ultrasonography will be performed once daily on patients diagnosed with sepsis associated encephalopathy at the bedside by two experienced examiners, who will be blinded to patients' clinical data, following the CLOSED protocol for ONSD sonography. ONSD will be measured at 3 mm behind the merging point of the nerve from the papilla "optic disc". The maximum external diameter of ONSD will be measured in the transverse plane perpendicular to the optic nerve and the maximum diameter of ETD (parallel lens) on this plane will be measured. Two measurements will be taken for each eye; horizontal and vertical. The sequence for measurements will be left eye horizontal; left eye vertical; right eye horizontal; right eye vertical. The ONSD measurements in the transversal and the sagittal plane for each eye measured by the two examiners will be averaged. Then, ETDs measurements will be averaged to obtain averaged ONSD/ETD ratio as a data to record the mean values of ONSD/ETD ratio.

ONSD / ETD Ratio Correlation With Prognosis of Sepsis Associated Encephalopathy

Eligibility Criteria

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

Study Population

SAE will be diagnosed by the combination of extracranial infection and clinical signs of neurological dysfunction. SAE clinical manifestations include impairment of awareness, which ranges from delirium to coma.

You may qualify if:

• Acceptance of one of patient's 1st degree relatives.
• Age ≥ 18 and ≤ 65 years old of both sexes.
• Sedated or unconscious patients and on invasive mechanical ventilation.
• Patients diagnosed with sepsis associated encephalopathy (SAE);

You may not qualify if:

• Ocular and/or optic nerve pathology; e.g., ocular trauma or surgery, previous ocular pathology as glaucoma or cataract, conjunctival or orbital edema, vitreous hemorrhage and optic nerve disease or injury.
• Intracranial pathology; e.g., central nervous system (CNS) infection, cerebrovascular accident, cerebral hemorrhage, brain trauma or tumor, and any previous neurosurgical procedure.
• Toxic or metabolic encephalopathy, e.g., alcohol toxicity, liver or kidney disease.
• Serious co-morbidities that could affect life expectancy, e.g., hematopathy or cancer.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Ashraf Torki

Zagazig, Sharqia Province, 44111, Egypt

Location

Related Publications (10)

• Raffiz M, Abdullah JM. Optic nerve sheath diameter measurement: a means of detecting raised ICP in adult traumatic and non-traumatic neurosurgical patients. Am J Emerg Med. 2017 Jan;35(1):150-153. doi: 10.1016/j.ajem.2016.09.044. Epub 2016 Sep 23.

  PMID: 27852525 BACKGROUND

• Zhu S, Cheng C, Zhao D, Zhao Y, Liu X, Zhang J. The clinical and prognostic values of optic nerve sheath diameter and optic nerve sheath diameter/eyeball transverse diameter ratio in comatose patients with supratentorial lesions. BMC Neurol. 2021 Jul 2;21(1):259. doi: 10.1186/s12883-021-02285-7.

  PMID: 34215217 BACKGROUND

• Onder H, Goksungur G, Eliacik S, Ulusoy EK, Arslan G. The significance of ONSD, ONSD/ETD ratio, and other neuroimaging parameters in idiopathic intracranial hypertension. Neurol Res. 2021 Dec;43(12):1098-1106. doi: 10.1080/01616412.2021.1949688. Epub 2021 Aug 19.

  PMID: 34409925 BACKGROUND

• Hassen GW, Bruck I, Donahue J, Mason B, Sweeney B, Saab W, Weedon J, Patel N, Perry K, Matari H, Jaiswal R, Kalantari H. Accuracy of optic nerve sheath diameter measurement by emergency physicians using bedside ultrasound. J Emerg Med. 2015 Apr;48(4):450-7. doi: 10.1016/j.jemermed.2014.09.060. Epub 2014 Dec 9.

  PMID: 25497897 BACKGROUND

• Zhu S, Cheng C, Wang LL, Zhao DJ, Zhao YL, Liu XZ. Prognostic values of optic nerve sheath diameter for comatose patients with acute stroke: An observational study. World J Clin Cases. 2022 Nov 26;10(33):12175-12183. doi: 10.12998/wjcc.v10.i33.12175.

  PMID: 36483822 BACKGROUND

• Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med. 2017 Mar;43(3):304-377. doi: 10.1007/s00134-017-4683-6. Epub 2017 Jan 18.

  PMID: 28101605 BACKGROUND

• Aspide R, Bertolini G, Albini Riccioli L, Mazzatenta D, Palandri G, Biasucci DG. A Proposal for a New Protocol for Sonographic Assessment of the Optic Nerve Sheath Diameter: The CLOSED Protocol. Neurocrit Care. 2020 Feb;32(1):327-332. doi: 10.1007/s12028-019-00853-x.

  PMID: 31583527 BACKGROUND

• Wijdicks EF, Bamlet WR, Maramattom BV, Manno EM, McClelland RL. Validation of a new coma scale: The FOUR score. Ann Neurol. 2005 Oct;58(4):585-93. doi: 10.1002/ana.20611.

  PMID: 16178024 BACKGROUND

• Gaastra B, Ren D, Alexander S, Awad IA, Blackburn S, Dore S, Hanley D, Nyquist P, Bulters D, Galea I. Evidence-based interconversion of the Glasgow Outcome and modified Rankin scales: pitfalls and best practices. J Stroke Cerebrovasc Dis. 2022 Dec;31(12):106845. doi: 10.1016/j.jstrokecerebrovasdis.2022.106845. Epub 2022 Oct 26.

  PMID: 36309002 BACKGROUND

• Anderson CS, Heeley E, Huang Y, Wang J, Stapf C, Delcourt C, Lindley R, Robinson T, Lavados P, Neal B, Hata J, Arima H, Parsons M, Li Y, Wang J, Heritier S, Li Q, Woodward M, Simes RJ, Davis SM, Chalmers J; INTERACT2 Investigators. Rapid blood-pressure lowering in patients with acute intracerebral hemorrhage. N Engl J Med. 2013 Jun 20;368(25):2355-65. doi: 10.1056/NEJMoa1214609. Epub 2013 May 29.

  PMID: 23713578 BACKGROUND

MeSH Terms

Conditions

Sepsis-Associated Encephalopathy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Ashraf Torki, MD

  Anesthesia and surgical intensive care, zagazig university, faculty of medicine

  PRINCIPAL INVESTIGATOR

• Mona Shahin, MD

  Anesthesia and surgical intensive care, zagazig university, faculty of medicine

  STUDY DIRECTOR

• Sherif MS Mowafy, MD

  Anesthesia and surgical intensive care, zagazig university, faculty of medicine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, Zagazig University (Principal Investigator)

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 26, 2023
• Study Start: March 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 10, 2024
• Last Updated: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)