Optic Nerve Sheath Diameter for Prediction of Sepsis Associated Encephalopathy

March 19, 2024 updated by: Sherif M. S. Mowafy, Zagazig University

The Role of Ultrasonographic Assessment of Optic Nerve Sheath Diameter in Prediction of Sepsis Associated Encephalopathy

Sepsis-associated brain dysfunction (SABD)with increased intracranial pressure is a complex pathology that can lead to unfavourable outcome. Although direct measurement of intracranial pressure using an intra-ventricular catheter remains the gold standard, it is burdened with potential serious complications due to its invasiveness. Ultrasonic measurement of optic nerve sheath diameter (ONSD) is a non-invasive method for ICP monitoring.

Screening for SABD is crucial for early diagnosis and management, measurement of ONSD can detect elevated intracranial pressure in septic patients. Intracranial hypertension in septic patients might be a sign of SABD.

Using ONSD for SABD screening requires further research. So, we hypothesized that ONSD could be used as an objective screening tool to predict and early diagnose SABD in adult septic patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Sepsis is the most common complication in adult critically ill patients, and it has been become the leading cause of morbidity and mortality worldwide. The essential component of sepsis is the presence of an acute organ dysfunction. The brain is highly vulnerable to the inflammatory storm associated with infection and it may be the first organ to show signs of life-threatening organ dysfunction caused by infection. This brain dysfunction is known as "sepsis-associated encephalopathy (SAE)".

Sepsis-associated brain dysfunction is considered the commonest type of encephalopathy seen in intensive care unit (ICU). it is defined as a life- threatening acute diffuse brain dysfunction due to infection outside the central nervous system (CNS) and is mostly caused by the inflammatory storm. It varies from delirium or confusion, seizure or focal neurological sign, and diffuse or multifocal neurological deficits, to stupor or coma with no other diagnoses describing the patient neurological status. SAE may occur in up to 70% of septic patients and it significantly increases mortality. It is a complex syndrome with unclear pathophysiology. The possible causes could include neuro-inflammation, excitotoxicity, impaired cerebral autoregulation, and cerebral ischemia. These Pathophysiological changes may lead to increase in the intracranial pressure (ICP) which may in turn decrease cerebral perfusion and lead to brain edema, brain damage and compromised the outcome of these patients. Therefore, early detection of increased ICP is of paramount importance for timely intervention and improved prognosis. However, direct invasive ICP monitoring is not routinely recommended in non-traumatic coma patients as well as septic patients either due to absence of intracranial infection or coagulopathy; so, a reliable non-invasive ICP monitoring method is highly recommended. Bedside ultrasonographic assessment of the optic nerve sheath diameter (ONSD) offers a satisfactory non-invasive ICP monitoring test and is documented as a sensitive and specific predictor of cerebral edema and is strongly correlated with both invasive ICP measurements and radiographic cerebral edema as diagnosed by CT scan or MRI.

Considering that SAE is a diagnosis of exclusion as well as screening method for SAE is necessary for early diagnosis and timely management. We hypothesized that ONSD could have a role as an objective screening tool to predict and early diagnose ICP changes in septic patients.

Study Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Sharkia
      • Zagazig, Sharkia, Egypt, 44111
        • Recruiting
        • Zagazig University Hospitals
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Patients diagnosed with sepsis will be enrolled and the severity of clinical illness will be assessed using APACHE II on ICU admission. SOFA will be calculated daily.

Patients who have changes in mental state, especially in consciousness and cognition, and other factors that cause mental changes were excluded as well as brain CT already ordered. Therefore, managing ICU team decided to diagnose patient with SAE.

Accordingly, patients will be divided into non-SAE group: include fully conscious patients suffering from sepsis for fewer than 24 h.

SAE group: include patients with sepsis for fewer than 24 h, suffering from acute onset of disturbed conscious level.

All enrolled subjects will undergo ONSD assessment within 24 h of admission and they will be eligible for ONSD measurements, SOFA score calculation, as well as GCS assessment on daily basis for up to 10 consecutive days, until ICU discharge or death.

Description

Inclusion Criteria:

  • Patient acceptance.
  • Age 21- 70 years old.
  • Patients diagnosed with sepsis For diagnosis of sepsis and septic shock, the third international definition and appropriate diagnostic criteria was used.

Sepsis was defined as life-threatening organ dysfunction caused by a dysregulated host response to an infection, and it is suspected in an acutely deteriorating patient in whom there is clinical evidence or strong suspicion of infection. Septic shock was defined as the need for vasopressors or vasoactive medication to maintain a mean arterial blood pressure of 65 mmHg or higher after adequate fluid resuscitation, with the presence of a high lactate (>2 mmol/l).

Exclusion Criteria:

  • Patient refusal.
  • Ocular wound
  • History of prior ocular trauma or surgery
  • Conjunctival edema or orbital edema
  • Vitreous hemorrhage
  • Central nervous system (CNS) infection
  • Cerebrovascular accident
  • Brain trauma
  • Any previous neurosurgical procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adult critically ill septic patients
Diagnostic test: Ultrasound measurement of Optic nerve sheath diameter
Ocular ultrasonography will be performed by single skilled examiner with patients placed in supine position with closed eyes. A layer of ultrasound gel will be applied over the closed upper eyelid and the liner high frequency probe 7 - 12 MHz of SonoSite M-Turbo ultrasound machine is placed on temporal area of eyelid with the hand holding it resting on forehead of patient. ONSD is measured 3mm behind the globe in the transverse plane perpendicular to the optic nerve. For each eye one measurement will be made and the reported ONSD corresponds to the mean of the two values obtained for each patient. An average ONSD greater than 5 mm is considered abnormal and elevated intracranial pressure should be suspected. all enrolled subjects will be eligible for ONSD measurements, SOFA score calculation, as well as GCS assessment on daily basis for up to 10 consecutive days, until ICU discharge or death.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation between ONSD measurements and the occurrence of SAE
Time Frame: 10 days
ultrasonographic measurement of optic nerve sheath diameter (ONSD) will be performed and recorded on daily basis for up to 10 consecutive days, until ICU discharge or death then we will compare the ONSD measurements of non-SAE patients to those of SAE patients.
10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the correlation between ONSD measurements and the ICU mortality of critically ill patients with sepsis
Time Frame: 30 days
ultrasonographic measurement of optic nerve sheath diameter (ONSD) will be performed and recorded on daily basis for up to 10 consecutive days, until ICU discharge or death then we will compare the ONSD measurements of ICU survivors to those of dead patients during the ICU stay.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Investigators

  • Principal Investigator: Sherif MS Mowafy, MD, Anaesthesia, Intensive Care, and Pain Management Department. Faculty of Medicine, Zagazig University,

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2023

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

May 30, 2024

Study Registration Dates

First Submitted

February 11, 2023

First Submitted That Met QC Criteria

May 7, 2023

First Posted (Actual)

May 9, 2023

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10597-30-4-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all IPD that underlie results in a publication

IPD Sharing Time Frame

the IPD and any additional supporting information will become available starting 6 months after publication

IPD Sharing Access Criteria

by contacting the study investigator

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sepsis

Clinical Trials on Ultrasound measurement of Optic nerve sheath diameter

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe