Hypertonic Saline for Brain Disorders

Overseen By Catherine Roth, MPH

Age: < 65

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Joseph D. Tobias

Disqualifiers: Arterial cannula not indicated, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

75 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a prospective, randomized study in patients greater than or equal to 10 years of age scheduled for an posterior spinal fusion that requires invasive monitoring of arterial blood pressure. Subjects will be randomized to receive either standard of care Normosol-R 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 and use of adjunctive volume resuscitation with 5% albumin for intraoperative resuscitation when using standard Normosol-R or a novel buffered 2% saline solution.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Buffered 2% Hypertonic Saline for brain disorders?

Research shows that hypertonic saline solutions, like the 2% version, can help reduce brain swelling and improve outcomes in brain injuries. Studies suggest they are effective in managing traumatic brain injuries by decreasing brain size and improving blood flow. ^{1 2 3 4 5}

Is hypertonic saline safe for use in humans?

Research shows that hypertonic saline, including 2%, 3%, and 23.4% solutions, is generally safe for treating brain-related conditions like cerebral edema and traumatic brain injury. It has been safely used in both emergency and tactical settings, although more studies are needed to confirm its safety in all situations. ^{3 4 6 7 8}

How is Buffered 2% Hypertonic Saline different from other treatments for brain disorders?

Buffered 2% Hypertonic Saline is unique because it is used as an osmotherapy to reduce brain swelling, particularly in cases of traumatic brain injury. It has advantages over other treatments like mannitol, as it can improve blood flow in the brain and reduce pressure inside the skull, although more research is needed to confirm its routine use. ^{1 4 5 9 10}

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intraoperative Treatment

Participants receive either 0.9% normal saline or buffered 2% hypertonic saline for fluid resuscitation during surgery

4-6 hours

Single visit (in-person, during surgery)

Follow-up

Participants are monitored for safety and effectiveness after surgery

4 weeks

Treatment Details

Interventions

• Buffered 2% Hypertonic Saline

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 standard of care isotonic fluid for fluid resuscitation during intraoperative care.

Group II: Normosol-R Active Control 1 Intervention

Isotonic solution of balanced electrolytes in water for fluid resuscitation during intraoperative care.

Who Is Running the Clinical Trial?

Joseph D. Tobias

Lead Sponsor

Trials

24

Recruited

4,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Variable change in renal function by hypertonic saline. [2021]

2. France pubmed.ncbi.nlm.nih.gov

Effect of continuous infusion of hypertonic saline solution on survival of patients with brain injury: a systematic review and meta-analysis. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

23.4% Hypertonic Saline: A Tactical Option for the Management of Severe Traumatic Brain Injury With Impending or Ongoing Herniation. [2022]

4. England pubmed.ncbi.nlm.nih.gov

The role of hypertonic saline in neurotrauma. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Hypertonic saline solutions in brain injury. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Early continuous hypertonic saline infusion in patients with severe cerebrovascular disease. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Safety of peripheral 3% hypertonic saline bolus administration for neurologic emergency. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Management of hyponatremic seizures in children with hypertonic saline: a safe and effective strategy. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Hypertonic saline and its effect on intracranial pressure, cerebral perfusion pressure, and brain tissue oxygen. [2013]

10. United States pubmed.ncbi.nlm.nih.gov

23.4% Hypertonic Saline and Intracranial Pressure in Severe Traumatic Brain Injury Among Children: A 10-Year Retrospective Analysis. [2020]