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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how different fluid solutions affect patients during spinal fusion surgery. Researchers compare a new type of saline, Buffered 2% Hypertonic Saline, to the standard fluid used to maintain bodily balance during surgery. The study focuses on the impact of these solutions on the body's acid-base balance and electrolytes. Individuals who have undergone spinal fusion surgery with close blood pressure monitoring using special equipment might be suitable candidates. As a Phase 2/3 trial, this research evaluates the treatment's effectiveness in a smaller group and represents the final step before FDA approval, offering participants an opportunity to contribute to significant medical advancements.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that hypertonic saline solutions, such as the buffered 2% saline being tested, have been used to treat brain-related conditions. Studies with various strengths of hypertonic saline have found no unexpected side effects, indicating general safety. For instance, hypertonic saline effectively lowers pressure inside the skull without causing surprising negative effects. Although the specific 2% concentration in this trial is new, the overall safety record of hypertonic saline in other studies offers reassurance about its safety in humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Buffered 2% hypertonic saline is unique because it offers a new approach to fluid resuscitation during intraoperative care for brain disorders. Unlike the standard isotonic solutions, like Normosol-R, which simply replace lost fluids, hypertonic saline is designed to draw fluid out of swollen brain tissues, potentially reducing brain swelling more effectively. Researchers are excited because this could lead to faster and more efficient management of brain edema, improving patient outcomes during surgeries.

What evidence suggests that buffered 2% hypertonic saline is effective for intraoperative fluid resuscitation?

Research has shown that hypertonic saline, like the buffered 2% solution in this trial, may help treat brain conditions. Participants will receive either the buffered 2% hypertonic saline or the active comparator, Normosol-R. Studies have found that hypertonic saline can significantly reduce brain swelling in traumatic brain injury (TBI) and decrease intracranial pressure. Lowering this pressure can lead to better recovery, such as improved scores on the Glasgow Coma Scale, which measures consciousness. Additionally, hypertonic saline has proven effective even when other treatments, like mannitol, have not been as successful. These findings suggest that hypertonic saline could be a valuable option for managing brain issues during surgery. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9677698/

Hypertonic saline for traumatic brain injury: a systematic ... This systematic review and meta-analysis evaluates the effectiveness of HTS in the management of patients with TBI.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7490798/

Hypertonic saline improves brain edema resulting from ... It was demonstrated that HS treatment significantly reduced brain edema in TBI rats and downregulated AQP4 expression in cerebral cortical tissues around the ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1878875022003473

Hypertonic Saline Treatment in Traumatic Brain Injury Infusions of 3% and 7.5% HTS are the most used concentrations given their efficacy in reducing intracranial pressure (ICP) and improving GCS score. In addition, ...

4. ahajournals.org ahajournals.org/doi/10.1161/hs0102.100877

Effects of Hypertonic (10%) Saline in Patients With Raised ... Conclusions— Infusion of 75 mL hypertonic (10%) saline decreases elevated ICP and increases cerebral perfusion pressure in stroke patients in whom mannitol had ...

5. ccforum.biomedcentral.com ccforum.biomedcentral.com/articles/10.1186/s13054-023-04311-1

Impact of continuous hypertonic (NaCl 20%) saline solution on ... Despite a significant increase in chloride intake, a continuous infusion of HSS was not associated with AKI in moderate-to-severe TBI patients.

6. accp.com accp.com/docs/bookstore/ccsap/cc2022b1_sample.pdf

Treatment of Elevated Intracranial Pressure Effect of continuous infusion of hypertonic saline vs. standard care on 6-month neurological outcomes in patients with traumatic brain injury: the COBI ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4268196/

Hypertonic saline solution reduces the oxidative stress ... Hypertonic saline 5% has significant effects on the oxidant responses compared to mannitol following TBI that makes HTS as a perfect therapeutic intervention.

8. link.springer.com link.springer.com/article/10.1007/s12640-024-00722-2

No Benefit of 3% Hypertonic Saline Following ... After ICH, the mass effect of the hematoma and edema contribute to raised intracranial pressure (ICP) and poor outcome. Endogenous compensatory ...