Hypertonic Saline in Posterior Spinal Fusion

Phase 2

Not yet recruiting

• Conditions: Scoliosis Idiopathic; Scoliosis;Congenital
• Interventions: Drug: buffered 2% hypertonic saline; Drug: Normosol-R

• Registration Number: NCT06822374
• Lead Sponsor: Joseph D. Tobias

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-31
• Study First Submitted QC: 2025-02-06
• Study First Posted: 2025-02-12
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-11
• Study Start: 2025-07
• Primary Completion: 2028-05
• Study Completion: 2028-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Patients > or = 10 years of age
• ASA 1-3
• Undergoing a PSF procedure requiring two peripheral intravenous infusions and an arterial cannula

Exclusion Criteria

• Arterial cannula is not indicated for the surgical procedure
• Two peripheral intravenous cannulas are not required
• An invasive arterial cannula cannot be placed

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypertonic saline	buffered 2% hypertonic saline	Buffered 2% saline solution instead of standard of care isotonic fluid for fluid resuscitation during intraoperative care.
Normosol-R	Normosol-R	Isotonic solution of balanced electrolytes in water for fluid resuscitation during intraoperative care.

Primary Outcome Measures

Name	Time	Method
pH	Every 1-2 hours during the surgery	pH level from arterial blood gas.
Base deficit	Every 1-2 hours during the surgery	Base deficit level from arterial blood gas.
Sodium	Every 1-2 hours during the surgery	Sodium level from arterial blood gas.
Ionized calcium	Every 1-2 hours during the surgery	Ionized calcium level from arterial blood gas.
Potassium	Every 1-2 hours during the surgery	Potassium level from arterial blood gas.

Secondary Outcome Measures

Name	Time	Method
Fluid volume	Duration of surgery (approx. 4-6 hrs.)	Volume of fluid required for intraoperative resuscitation.

Trial Locations

Locations (1)

Nationwide Children's; 🇺🇸 Columbus, Ohio, United States