Hypertonic Saline in Posterior Spinal Fusion

NCT06822374 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: STUDY00005116
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Scoliosis Idiopathic; Scoliosis;Congenital

Keywords

intraoperative fluid resuscitation

Outcome Measures

Primary Outcomes (5)

• pH

  pH level from arterial blood gas.

  Every 1-2 hours during the surgery

• Base deficit

  Base deficit level from arterial blood gas.

  Every 1-2 hours during the surgery

• Sodium

  Sodium level from arterial blood gas.

  Every 1-2 hours during the surgery

• Ionized calcium

  Ionized calcium level from arterial blood gas.

  Every 1-2 hours during the surgery

• Potassium

  Potassium level from arterial blood gas.

  Every 1-2 hours during the surgery

Secondary Outcomes (1)

• Fluid volume

  Duration of surgery (approx. 4-6 hrs.)

Study Arms (2)

Hypertonic saline

EXPERIMENTAL

Buffered 2% saline solution instead of standard of care isotonic fluid for fluid resuscitation during intraoperative care.

Drug: buffered 2% hypertonic saline

Normosol-R

ACTIVE COMPARATOR

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

Drug: Normosol-R

Interventions

Normosol-R DRUG

Standard of care isotonic fluid.

Normosol-R

buffered 2% hypertonic saline DRUG

A solution containing 2% sodium chloride (NaCl) that is "buffered" by the addition of another salt like sodium acetate.

Hypertonic saline

Eligibility Criteria

• Age: 10 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Joseph D. Tobias: lead

Study Sites (1)

Nationwide Children's

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Interventions

Plasmalyte A; Ampholyte Mixtures; Saline Solution, Hypertonic

Intervention Hierarchy (Ancestors)

Buffers; Laboratory Chemicals; Specialty Uses of Chemicals; Chemical Actions and Uses; Hypertonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief, Department of Anesthesiology & Pain Medicine

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 12, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)