An observational study in Sepsis, sponsored by Zagazig University. Completed at 2 sites in Egypt. Open to participants aged 21 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-06-04.
Sponsored by Zagazig University · Observational
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.
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.
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's enrollment of 89 is below the median of 160 across 931 observational studies indexed under Sepsis.
Browse Sepsis studies →Zagazig University is the lead sponsor of 447 studies on the registry; 75 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
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:
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.
correlation between ONSD measurements and the occurrence of SAE
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.
Time frame: 10 days
the correlation between ONSD measurements and the ICU mortality of critically ill patients with sepsis
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.
Time frame: 30 days
Plan to share: Yes — all IPD that underlie results in a publication
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Zagazig University