Randomized Trial of the Safety and Effectiveness of 3% vs. 23% Hypertonic Saline for the Treatment of Pediatric Intracranial Hypertension: A Pilot Study

Study ID
STU 042011-100

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Lakshmi Raman
214-648-1242
lakshmi.raman@utsouthwestern.edu

Principal Investigator
Lakshmi Raman

Summary

This is a single center, prospective, randomized trial of 23% hypertonic saline as a safe and effective treatment for intracranial hypertension following severe pediatric TBi. Patients who experience intracranial hypertension greater than 20 mmHg for 15 minutes after traumatic brain injury and who need osmotic therapy will be randomized to one of two arms: a 23% (0.5cc/kg) HTS arm and a 3% (5cc/kg) HTS arm. There will be 10 patients in each arm. Study staff will randomize the patient through www.randomizer.org, a website that uses a JavaScript random number generator to produce customized sets of random numbers. HTS will be administered for each episode of elevated iCP greater than 20 mmHg for 15 minutes for as long as the patient is in the iCu and receives hyperosmolar therapy. once a patient has been randomized to a treatment arm, that patient will receive the same concentration of HTS (23% or 3%) throughout the study period. in other words, if a patient is randomized to 23% after his first elevated iCP, he will continue to receive 23% HTS for the treatment of subsequent iCP spikes. Study protocol will last as long as the patient is in the iCu and continues to receive hyperosmolar therapy. Safety data will be collected until 24 hours after the last iCP spike.

in each arm, intracranial pressure will be measured every 15 minutes for four hours from the end of the hypertonic saline infusion. Primary study endpoint will be the amount of decrease in iCP after HTS administration. Secondary study endpoints will be the number of iCP spikes within 3 hours after HTS administration.

Participant Eligibility

- Children between the ages of 3 months and 18 years of age.
- Diagnosed traumatic brain injury (penetrating or non-penetrating)
- Glasgow Coma Scale score of 8 or less
- Glasgow Motor component less than 6
- Need for osmotic therapy (based on ICP measurement)