Optic Nerve SheathEarly Phase 1NCT04686344
Point of Care Optic Nerve Sheath Ultrasound to Assess Intracranial Pressure
A Early Phase 1 study testing intermittent boluses of Hypertonic saline and continuous infusion of Hypertonic saline in people with Optic Nerve Sheath and Hypertonic Saline, run by Cairo University at 2 sites in Egypt.
Trial summary
Elevated intracranial pressure (ICP) is one of the most common symptoms encountered in a variety of traumatic injuries and diseases. Any tissue swelling within the rigid confines of the skull results in increased ICP, which may lead to life-threatening structural alterations in the brain or cerebral blood flow, thus… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Optic Nerve Sheath, Hypertonic Saline
- What is being tested?
- intermittent boluses of Hypertonic saline and continuous infusion of Hypertonic saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesEgypt
- Study dates
- 21 Dec 2020to 30 Aug 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients who having Isolated traumatized brain injury (not for surgical intervention)
- 3<GCS ≤ 12.
- Both genders.
- Age ≥ 18 and ≤ 60Years.
- Physical status ASA I - III.
- Cut off value for optic nerve sheath diameter (ONSD) as 5.5 mm to diagnose increase in ICP> 20 mm Hg.
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- 2. Exclusion criteria
- Patients' first-degree relatives' refusal to sign the consent.
- GCS (Glasgow coma score) >12 or GCS of 3.
- Contraindication to hypertonic saline: pregnancy, coagulopathy and cardiac dysfunction.
- Spinal cord injury, orbital injury, optic nerve injury and optic neuritis.
- Multi organ affection.
- Serum Na level ≥ 150 mmol/L at admission to ICU.
- Hypotension requiring vasopressors to maintain MAP above 60 mmHg.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Cairo university
Cairo, 11451
Faculty of Medicine, Cairo University.
Cairo, 11451
About this study
Official title: Sonography of the Optic Nerve Sheath Diameter for Comparison Between the Effects of Continuous Infusion of 3%Hypertonic Saline With Intermittent Boluses Versus in Patients With Traumatic Brain Injury.
Elevated intracranial pressure (ICP) is one of the most common symptoms encountered in a variety of traumatic injuries and diseases. Any tissue swelling within the rigid confines of the skull results in increased ICP, which may lead to life-threatening structural alterations in the brain or cerebral blood flow, thus causing oxygen deprivation and ischemia in the brain.
Methods for ICP monitoring can be divided into invasive and noninvasive approaches. In fluid-based systems, external ventricular drainage (EVD) has been considered the gold standard.
Read more
Clinicians have found several noninvasive methods that can be used as surrogates for invasive methods for ICP measurement. The optic nerve, as part of the central nervous system, is wrapped by the dural sheath. The optic nerve sheath (ONS) is the continuation of the subarachnoid space at the optic nerve, and its tissues are connected with the subarachnoid space. Thus, an increase in ICP results in a corresponding elevation of the ONS diameter (ONSD).
Hypertonic solutions such as mannitol and hypertonic saline (HTS) are recommended early in the management of ICH after severe TBI . They provide therapeutic benefit along with a wide therapeutic margin. The most recent BTF guidelines stated "although hyperosmolar therapy may lower intracranial pressure, there was insufficient evidence about effects on clinical outcomes to support a specific recommendation, or to support use of any specific hyperosmolar agent".
- Conditions
- Optic Nerve Sheath, Hypertonic Saline
- Being tested
- intermittent boluses of Hypertonic saline, continuous infusion of Hypertonic saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intermittent boluses of Hypertonic salineDrug
intermittent boluses every 6 hours over 30 min for 48 hours
continuous infusion of Hypertonic salineDrug
continuous infusion over a period of 48 hours
| Study group | Role | What they receive |
|---|---|---|
| Hypertonic saline continuous infusion Group | Active comparator | will receive Hypertonic saline continuous infusion Receives: Drug: continuous infusion of Hypertonic saline |
| Hypertonic saline intermittent boluses Group | Active comparator | will receive Hypertonic saline intermittent boluses for 48 hours Receives: Drug: intermittent boluses of Hypertonic saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diameter of Optic nerve sheath
assessment tool for Intracranial pressure
Measured: UP TO 48 HOURS
Secondary outcomes (2)
intracranial pressure
Rebound increase intracranial pressure
Measured: up to 72 hours
level of Conscious
Glasgow Coma Score : A person's GCS score can range from 3 (completely unresponsive) to 15 (responsive).
Measured: UP TO 30 DAY
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start21 Dec 2020
- Primary completion10 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optic Nerve SheathStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Samir Wahdan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04686344
- Sponsor's protocol ID
- MS-383-2020
- Status last verified
- Sep 2021
- First submitted
- 19 Dec 2020
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonography of the Optic Nerve Sheath Diameter for Comparison Between the Effects of Continuous Infusion of 3%Hypertonic Saline With Intermittent Boluses Versus in Patients With Traumatic Brain Injury.
- ClinicalTrials.gov ID
- NCT04686344
- Acronym / sponsor ID
- MS-383-2020
- Conditions
- Optic Nerve Sheath, Hypertonic Saline
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 21 Dec 2020 (actual)
- Primary completion
- 10 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 28 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Elevated intracranial pressure (ICP) is one of the most common symptoms encountered in a variety of traumatic injuries and diseases. Any tissue swelling within the rigid confines of the skull results in increased ICP, which may lead to life-threatening structural alterations in the brain or cerebral blood flow, thus causing oxygen deprivation and ischemia in the brain.
Methods for ICP monitoring can be divided into invasive and noninvasive approaches. In fluid-based systems, external ventricular drainage (EVD) has been considered the gold standard.
Clinicians have found several noninvasive methods that can be used as surrogates for invasive methods for ICP measurement. The optic nerve, as part of the central nervous system, is wrapped by the dural sheath. The optic nerve sheath (ONS) is the continuation of the subarachnoid space at the optic nerve, and its tissues are connected with the subarachnoid space. Thus, an increase in ICP results in a corresponding elevation of the ONS diameter (ONSD).
Hypertonic solutions such as mannitol and hypertonic saline (HTS) are recommended early in the management of ICH after severe TBI . They provide therapeutic benefit along with a wide therapeutic margin. The most recent BTF guidelines stated "although hyperosmolar therapy may lower intracranial pressure, there was insufficient evidence about effects on clinical outcomes to support a specific recommendation, or to support use of any specific hyperosmolar agent".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypertonic saline continuous infusion Group | Active comparator | Drug: continuous infusion of Hypertonic salinewill receive Hypertonic saline continuous infusion |
| Hypertonic saline intermittent boluses Group | Active comparator | Drug: intermittent boluses of Hypertonic salinewill receive Hypertonic saline intermittent boluses for 48 hours |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Patients who having Isolated traumatized brain injury (not for surgical intervention)
- 3<GCS ≤ 12.
- Both genders.
- Age ≥ 18 and ≤ 60Years.
- Physical status ASA I - III.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intermittent boluses of Hypertonic salineintermittent boluses every 6 hours over 30 min for 48 hours | Drug | Hypertonic saline intermittent boluses Group |
| continuous infusion of Hypertonic salinecontinuous infusion over a period of 48 hours | Drug | Hypertonic saline continuous infusion Group |
Primary outcome
Diameter of Optic nerve sheath
Time frame: UP TO 48 HOURS
assessment tool for Intracranial pressure
2 secondary outcomes
intracranial pressure
Time frame: up to 72 hours
level of Conscious
Time frame: UP TO 30 DAY
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing intermittent boluses of Hypertonic saline and continuous infusion of Hypertonic saline in people with Optic Nerve Sheath and Hypertonic Saline, run by Cairo University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diameter of Optic nerve sheath (time frame: UP TO 48 HOURS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2021.