NCT06822374

Hypertonic Saline in Posterior Spinal Fusion

Use of a Buffered 2% Hypertonic Saline Solution During Posterior Spinal Fusion

• Status: Withdrawn
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Joseph D. Tobias · Academic / Other
• Sex: All
• Age: 10 Years – 25 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Scoliosis Idiopathic
• Scoliosis;Congenital

Interventions

Type	Name	Description
DRUG	Normosol-R	Standard of care isotonic fluid.
DRUG	buffered 2% hypertonic saline	A solution containing 2% sodium chloride (NaCl) that is "buffered" by the addition of another salt like sodium acetate.

Timeline

• Start date: 2025-12-01
• Primary completion: 2028-05-01
• Completion: 2028-05-01
• First posted: 2025-02-12
• Last updated: 2025-11-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study