Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 5:08 AM
Study NCT ID:
NCT07332234
Status:
RECRUITING
Last Update Posted:
2026-01-12
First Post:
2025-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optic Nerve Ultrasound for Assessing Cerebral Inflammation and Intracranial Hypertension in Cerebral Pathologies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008581', 'term': 'Meningitis'}, {'id': 'D004660', 'term': 'Encephalitis'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D019586', 'term': 'Intracranial Hypertension'}], 'ancestors': [{'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-09', 'studyFirstSubmitDate': '2025-12-03', 'studyFirstSubmitQcDate': '2026-01-09', 'lastUpdatePostDateStruct': {'date': '2026-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Optic Nerve Sheath Diameter', 'timeFrame': 'Daily during the first week of hospitalisation', 'description': 'The diameter of the optic nerve sheath measured ultrasonographically using a standardised method, 6mm from the surface of the retina'}], 'secondaryOutcomes': [{'measure': 'C-reactive protein', 'timeFrame': 'Day 1, day 3 and day 7', 'description': 'Measurement of systemic C-reactive protein (CRP) levels, as marker of systemic inflammation'}, {'measure': 'Neuron-specific Enolase', 'timeFrame': 'Day 1, day 3 and day 7', 'description': 'Measurement of neuron-specific enolase as a marker for brain cell death caused by CNS inflammation.'}, {'measure': 'CSF examination', 'timeFrame': 'Day 1, day 3 and day 7', 'description': 'Determining CSF immune cell count, CSF proteins, albumin, glucose, chloride and sodium, as well as bacterial or fungal cultures (where applicable).'}, {'measure': 'Glasgow Coma Scale', 'timeFrame': 'Daily during the first week of hospitalisation', 'description': "Evaluation tool used to assess a person's level of consciousness after brain injury or illness, rating their eye, verbal, and motor responses for a total score ranging from 3 (deep unconsciousness) to 15 (fully alert)."}, {'measure': 'Richmond Agitation-Sedation Scale', 'timeFrame': 'Daily during the first week of hospitalisation', 'description': "Ten-point clinical tool used in intensive care units to assess a patient's level of alertness, agitation, or sedation. Ranges from +4 (combative) to -5 (unarousable/comatose), 0 being alert and calm."}, {'measure': 'Middle Cerebral Artery Pulsatility Index', 'timeFrame': 'Daily during the first week of hospitalisation', 'description': 'Transcranial Doppler ultrasound used to measure the middle cerebral artery (MCA) pulsatility index (PI).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ONSD', 'Optic Nerve Sheath Diameter', 'Intracranial hypertension', 'Meningitis', 'Encephalitis', 'Stroke', 'Cerebral tumors'], 'conditions': ['Meningitis', 'Meningitis/Encephalitis', 'Stroke', 'Ultrasound', 'Intracranial Hypertension', 'Cerebral Tumors']}, 'descriptionModule': {'briefSummary': 'Timely detection of signs of raised intracranial pressure or persistent inflammation within the meninges can expedite therapeutic decisions improving the prognosis of patients with brain damage. Optic nerve ultrasonography provides a user-friendly, safe, low-cost, and non-invasive imaging method that can be easily deployed for ICU patient assessment. This study aims to evaluate the sensitivity and specificity of optic nerve ultrasound in estimating cerebral inflammation extension and cerebral edema in patients in the ICU. The working hypothesis is that optic nerve ultrasound is a useful tool in the rapid diagnosis of cerebral edema and the presence or persistence of cerebral inflammation, which can enable adapted and rapid therapeutic interventions.', 'detailedDescription': '"Utility of Optic Nerve Ultrasonography in Assessing Cerebral Inflammation and Intracranial Hypertension in Patients with Cerebral Impairment" - briefly, the EICON Study.\n\nInvestigators Principal Investigator (1): Bogdan PAVEL, MD, PhD, DESA, "Dr. Victor Babes" Clinical Hospital of Infectious and Tropical Diseases.\n\nPrincipal Investigator (2): Sebastian ISAC, MD, PhD, DESA, Fundeni Clinical Institute Principal Investigator (3): Prof. Gabriela DROC, M.D., Ph.D., Fundeni Clinical Institute\n\nStudy Design Study Type: Observational Estimated Number of Participants: 200 participants Primary Purpose: Evaluation Actual Study Start Date: December 1st, 2025 Estimated Primary Completion Date: December 1st, 2027 Estimated Study Completion Date: December 1st, 2027\n\nGroups and Interventions\n\nGroup 1: Infectious Pathology Group\n\nPatients admitted with suspected meningitis or encephalitis will undergo the following investigations:\n\nAssessment of consciousness using validated scales (GCS, RASS).\n\nOptic nerve ultrasound to measure the optic nerve sheath diameter (ONSD), performed according to the following protocol:\n\nThe patient is positioned supine at a 20-30° incline. A linear probe (9-10 MHz; depth=40 mm; focus=30 mm) is used. The optic nerve must be visible at least 6 mm posterior to the retina. The retinal artery is identified. The diameter of the optic nerve is measured 3 mm posterior to the retina in both the transverse and sagittal planes; the reported value is the mean of the two measurements.\n\nMeasurements are performed independently by two examiners. Transcranial Doppler (TCD) to determine the pulsatility index of the middle cerebral artery.\n\nComputed tomography (CT) to exclude intracranial hypertension. Lumbar puncture with measurement of cerebrospinal fluid (CSF) opening pressure. Blood sampling for C-reactive protein (CRP) and neuron-specific enolase (NSE) levels.\n\nDaily Monitoring During Hospitalization:\n\nDaily assessment of consciousness (GCS, RASS) at 09:00. Daily optic nerve ultrasound at 09:00 following the protocol described above. Daily TCD examination of the middle cerebral artery at 09:10. CT scan if clinical signs of intracranial hypertension develop or if there is a sudden decline in GCS of \\>3 points.\n\nRepeat lumbar puncture with CSF pressure measurement at 72 hours and 7 days after admission.\n\nBlood sampling for CRP, NSE, and total antioxidant capacity at admission, 72 hours, and 7 days.\n\nGroup 2: Patients With Non-Infectious Neurological Pathology\n\nPatients admitted with suspected stroke (CVA), brain tumors, or metabolic encephalopathy will undergo the following investigations:\n\nAssessment of consciousness using validated scales (GCS, RASS).\n\nOptic nerve ultrasound to measure the optic nerve sheath diameter (ONSD), performed according to the following protocol:\n\nThe patient is positioned supine at a 20-30° incline. A linear probe (9-10 MHz; depth=40 mm; focus=30 mm) is used. The optic nerve must be visible at least 6 mm posterior to the retina. The retinal artery is identified. The diameter of the optic nerve is measured 3 mm posterior to the retina in both the transverse and sagittal planes; the reported value is the mean of the two measurements.\n\nMeasurements are performed independently by two examiners. Transcranial Doppler (TCD) to determine the pulsatility index of the middle cerebral artery.\n\nComputed tomography (CT) to exclude intracranial hypertension. Lumbar puncture with measurement of cerebrospinal fluid (CSF) opening pressure. Blood sampling for C-reactive protein (CRP) and neuron-specific enolase (NSE) levels.\n\nDaily Monitoring During Hospitalization:\n\nDaily assessment of consciousness (GCS, RASS) at 09:00. Daily optic nerve ultrasound at 09:00 following the standardized measurement protocol.\n\nDaily TCD examination at 09:10 to assess the middle cerebral artery pulsatility index.\n\nCT scan if signs of intracranial hypertension appear or if the GCS decreases abruptly by \\>3 points.\n\nLumbar puncture with CSF pressure measurement at 72 hours and 7 days after admission (if applicable).\n\nBlood sampling for CRP and NSE levels at 72 hours and 7 days after admission.\n\nGeneral Objectives\n\n1. Primary Objectives:\n\n To evaluate the sensitivity and specificity of optic nerve ultrasound in the assessment of cerebral inflammation and cerebral edema.\n\n To establish threshold values for diagnosing intracranial hypertension, according to the specific pathology.\n\n To correlate the optic nerve diameter with the patients\' clinical condition.\n2. Secondary Objectives:\n\n28-day mortality Quality of life assessment on day 28 Rate of local and systemic complications\n\nInclusion Criteria:\n\n* Patients admitted into one of the specified wards of the involved hospitals\n* Patients aged 18-60 years\n* Suspected meningitis, encephalitis, stroke or cerebral tumors\n\nExclusion Criteria:\n\n* Age under 18 years or over 60 years old\n* Ocular lesions preventing ocular ultrasound (palpebral infections, cornean erosions, glaucoma, trauma)\n* Conditions preventing lumbar puncture (coagulation disorders, epidural abscesses, local infections)\n\nAll data is collected and stored electronically, using a tabular Excel file shared by all investigators.\n\nEthical Considerations: For this study, we request deferred consent and invoke the emergency consent procedure for medical research, in accordance with Article 6, paragraph 4 of the WMO. This approach is justified for the following reasons:\n\nPatients admitted to infectious disease, neurology, or intensive care units often lack the capacity to provide informed consent. Under the Medical Treatment Act (WGBO), individuals who may serve as legal representatives include: a pre-designated representative, a spouse, a registered or other life partner, a parent or child, a sibling, and, in some cases, a court-appointed guardian. However, legal representatives are frequently not present when patients are admitted to the ICU or when the inclusion criteria are met. Moreover, obtaining informed consent from a legal representative requires sufficient time for them to review and consider the information provided. In the acute phase of admission-particularly in the ICU-legal representatives are naturally focused on the patient\'s clinical status rather than participation in research.\n\nProcedures for Obtaining Consent Informed consent will be requested from the legal representative as soon as possible and no later than 48 hours after the inclusion criteria are met. If feasible, informed consent will be obtained in advance.\n\nIf informed consent from the legal representative is not obtained within 48 hours, or if the representative refuses participation within this period, the patient will be excluded and all collected data will be removed from the study.\n\nThe legal representative will receive both oral and written information, provided either in person or via telephone and email. Written informed consent may be returned by email within 12 hours of receiving the information, but always within the 48-hour window following inclusion.\n\nConsent received by email must subsequently be confirmed with a signed paper form as soon as possible, and no later than 48 hours after the emailed confirmation.\n\nRetrospective Consent From the Patient A second informed consent procedure will be conducted retrospectively once the patient regains capacity and is able to adequately understand the situation. At that time, the study information will be provided directly to the patient, and written informed consent will be requested and signed by both the patient and the executive investigator. If the patient declines participation, all data collected up to that point will be permanently deleted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted into the Anesthesia and Intensive Care Department of the Fundeni Clinical Institute in Bucharest, and the Anesthesia and Intensive Care Department and Infectious Diseases departments of the "Dr. Victor Babes" Hospital of Infectious Diseases in Bucharest', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted into one of the specified wards of the involved hospitals\n* Patients aged 18-60 years\n* Suspected meningitis, encephalitis, stroke or cerebral tumors\n\nExclusion Criteria:\n\n* Age under 18 years or over 60 years old\n* Ocular lesions preventing ocular ultrasound (palpebral infections, cornean erosions, glaucoma, trauma)\n* Conditions preventing lumbar puncture (coagulation disorders, epidural abscesses, local infections)'}, 'identificationModule': {'nctId': 'NCT07332234', 'acronym': 'EICON', 'briefTitle': 'Optic Nerve Ultrasound for Assessing Cerebral Inflammation and Intracranial Hypertension in Cerebral Pathologies', 'organization': {'class': 'OTHER', 'fullName': 'Spitalul Clinic de Boli Infecțioase și tropicale "Dr. Victor Babeș"'}, 'officialTitle': 'Utility of Optic Nerve Ultrasonography in Assessing Cerebral Inflammation and Intracranial Hypertension in Patients With Cerebral Impairment', 'orgStudyIdInfo': {'id': '18261-14/10/2025'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Infectious Pathology Group', 'description': 'Patients admitted into the hospital with suspected meningitis or encephalitis', 'interventionNames': ['Diagnostic Test: Optic Nerve Sheath Diameter']}, {'label': 'Non-Infectious Pathology Group', 'description': 'Patients admitted into the hospital with suspected stroke or cerebral tumors (non-infectious pathology)', 'interventionNames': ['Diagnostic Test: Optic Nerve Sheath Diameter']}], 'interventions': [{'name': 'Optic Nerve Sheath Diameter', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Ocular Ultrasound', 'Optic Nerve Sheath Ultrasonographic Diameter'], 'description': 'Ultrasonographic measurement of the optic nerve sheath diameter', 'armGroupLabels': ['Infectious Pathology Group', 'Non-Infectious Pathology Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '022315', 'city': 'Bucharest', 'state': 'Bucharest', 'status': 'RECRUITING', 'country': 'Romania', 'contacts': [{'name': 'Sebastian Isac, MD, PhD, DESA', 'role': 'CONTACT', 'email': 'sebastian.isac@umfcd.ro', 'phone': '+40744543736'}, {'name': 'Gabriela Droc, MD, PhD', 'role': 'CONTACT', 'email': 'gabriela.droc@umfcd.ro', 'phone': '+40722788820'}, {'name': 'Sebastian Isac, MD, PhD, DESA', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Gabriela Droc, MD, PhD, DESA', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fundeni Clinical Institute', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '030303', 'city': 'Bucharest', 'state': 'Bucharest', 'status': 'RECRUITING', 'country': 'Romania', 'contacts': [{'name': 'Bogdan Pavel, MD, PhD, DESA', 'role': 'CONTACT', 'email': 'bogdan.pavel@umfcd.ro', 'phone': '+40726116536'}, {'name': 'Rares Luca, MD', 'role': 'CONTACT', 'email': 'rares-daniel.luca@rez.umfcd.ro', 'phone': '+40745301540'}, {'name': 'Bogdan Pavel, MD, PhD, DESA', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Rares Luca, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': '"Dr. Victor Babeș" Clinical Hospital for Infectious and Tropical Diseases', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}], 'centralContacts': [{'name': 'Bogdan Pavel, MD, PhD, DESA', 'role': 'CONTACT', 'email': 'bogdan.pavel@umfcd.ro', 'phone': '+40726116536'}, {'name': 'Sebastian Isac, MD, PhD, DESA', 'role': 'CONTACT', 'email': 'sebastian.isac@umfcd.ro', 'phone': '+40744543736'}], 'overallOfficials': [{'name': 'Bogdan Pavel, MD, PhD, DESA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '"Dr. Victor Babeș" Clinical Hospital for Infectious and Tropical Diseases'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spitalul Clinic de Boli Infecțioase și tropicale "Dr. Victor Babeș"', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institutul Clinic Fundeni', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, DESA', 'investigatorFullName': 'Bogdan Pavel', 'investigatorAffiliation': 'Spitalul Clinic de Boli Infecțioase și tropicale "Dr. Victor Babeș"'}}}}