Who is sponsoring NCT04686344?

NCT04686344 is sponsored by Cairo University.

What drugs are being tested in NCT04686344?

Interventions in NCT04686344: intermittent boluses of Hypertonic saline, continuous infusion of Hypertonic saline.

What condition does NCT04686344 study?

NCT04686344 studies Optic Nerve Sheath, Hypertonic Saline.

Is NCT04686344 still recruiting?

NCT04686344 is currently completed. Last updated 17 September 2021.

Last reviewed 2021-09-17 · How we verify

NCT04686344

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Point of Care Optic Nerve Sheath Ultrasound to Assess Intracranial Pressure

Completed EARLY_PHASE1 Last updated 17 September 2021

What this trial tests

EARLY_PHASE1 trial testing intermittent boluses of Hypertonic saline in Optic Nerve Sheath in 50 participants. Completed in 30 August 2021.

Timeline

21 December 2020

Primary endpoint
10 August 2021

30 August 2021

Quick facts

Lead sponsor	Cairo University
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	50
Start date	21 December 2020
Primary completion	10 August 2021
Estimated completion	30 August 2021
Sites	2 locations across Egypt

Drugs / interventions tested

intermittent boluses of Hypertonic saline — full drug profile →
continuous infusion of Hypertonic saline — full drug profile →

Conditions studied

Optic Nerve Sheath — all drugs for Optic Nerve Sheath →
Hypertonic Saline — all drugs for Hypertonic Saline →

Sponsor

Cairo University

Who can join

Adults 18 to 60, any sex, with Optic Nerve Sheath or Hypertonic Saline. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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".

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04686344 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Cairo University
Last refreshed: 17 September 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04686344.

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