Hypertonic Saline for Brain Disorders

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Joseph D. Tobias

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This is a prospective, randomized study in patients 8-21 years of age scheduled for an intracranial surgical procedure that requires invasive monitoring of arterial blood pressure. Subjects will be randomized to receive either 0.9% normal saline or buffered 2% hypertonic saline for intraoperative fluid resuscitation. The primary objective of this study is to compare intraoperative changes in acid-base status and electrolytes based on the type of fluid administered intraoperatively. The secondary objective is to compare the volume of fluid required for intraoperative resuscitation when using standard 0.9% saline or a novel buffered 2% saline solution.

Research Team

Eligibility Criteria

This trial is for young patients aged 8-21 who are scheduled for brain surgery and need close blood pressure monitoring. They must require two IV infusions and an arterial cannula during surgery. Those not needing these or unable to have an arterial cannula placed cannot join.

Inclusion Criteria

I am scheduled for brain surgery.

I need two IV lines and an arterial line placed.

Exclusion Criteria

Two peripheral intravenous cannulas are not required

An invasive arterial cannula cannot be placed

Arterial cannula is not indicated for the surgical procedure

Treatment Details

Interventions

• Buffered 2% Hypertonic Saline (Electrolyte Solution)

Trial Overview The study compares the effects of two saline solutions used during brain surgery: standard 0.9% saline versus a buffered 2% hypertonic saline. It looks at how each solution affects acid-base balance, electrolytes, and the amount of fluid needed.

Participant Groups

Group I: Hypertonic saline Experimental Treatment 1 Intervention

Buffered 2% saline solution instead of 0.9% normal saline for fluid resuscitation during intraoperative care.

Group II: Normal saline Active Control 1 Intervention

Standard 0.9% normal saline for fluid resuscitation during intraoperative care.

Who Is Running the Clinical Trial?

Joseph D. Tobias

Lead Sponsor

Trials

24

Recruited

4,000+