Health Trials

Comparison of Hyperosmolar Agent in Reduction of Increased Intracranial Pressure in Patients With Traumatic Brain Injury Using Ultrasonography

ConditionsTBI (Traumatic Brain Injury)ICP (Intracranial Pressure) IncreaseOptic Nerve Sheath Diameter Measurement
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssiut University

About this trial

The aim of this study to compare the efficacy of hypertonic saline and mannitol in reducing intracranial pressure, as assessed by serial optic nerve sheath diameter (ONSD) ultrasound measurements, in patients with traumatic brain injury.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• Age ≥18 years.

Acute severe traumatic brain injury (TBI) (GCS 3-8) confirmed by CT brain.

Elevated ONSD suggestive of raised ICP (ONSD cutoff value ≥5.6 mm ).(14)

Initiation of hyperosmolar therapy within 24 hours of injury.

Disqualifiers

• Penetrating head injury.

Hypotension.

Previous ocular trauma or orbital surgery.

Glaucoma or optic nerve pathology.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mannitol (20%)

    Drug

    compare the efficacy of mannitol in reducing intracranial pressure, as assessed by serial optic nerve sheath diameter (ONSD) ultrasound measurements, in patients with traumatic brain injury.

  • Hypertonic Saline ( 3% Sodium Chloride Saline)

    Drug

    compare the efficacy of hypertoic saline in reducing intracranial pressure, as assessed by serial optic nerve sheath diameter (ONSD) ultrasound measurements, in patients with traumatic brain injury.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Group M (Mannitol)Active comparator 1 intervention
Group B: Group H (Hypertonic Saline)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in ONSD (mm) from baseline, after treatment (e.g., at 2 hour, 6 hours, and 24 hours).

Time frame
24 hours

Secondary outcomes

1

reduction of icp

1\. Time to achieve target ICP reduction following administration of the hyperosmolar agent., hemodynamic stability and the frequency of secondary rebound hypertension during acute resuscitation.

Time frame
1 hours, 6 hours, 24hours
2

GCS

Change in Glasgow Coma Scale (GCS) after treatment.

Time frame
24HOURS
3

serum electrolyte

Changes in serum electrolyte. sodium and osmolarity

Time frame
6hours, 24hours
4

surgery

Requirement for surgical intervention.

Time frame
24hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: