Hypertonic Saline in Posterior Spinal Fusion

November 7, 2025 updated by: Joseph D. Tobias

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hypertonic saline
Buffered 2% saline solution instead of standard of care isotonic fluid for fluid resuscitation during intraoperative care.
Drug: buffered 2% hypertonic saline
A solution containing 2% sodium chloride (NaCl) that is "buffered" by the addition of another salt like sodium acetate.
Active Comparator: Normosol-R
Isotonic solution of balanced electrolytes in water for fluid resuscitation during intraoperative care.
Drug: Normosol-R
Standard of care isotonic fluid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pH
Time Frame: Every 1-2 hours during the surgery
pH level from arterial blood gas.
Every 1-2 hours during the surgery
Base deficit
Time Frame: Every 1-2 hours during the surgery
Base deficit level from arterial blood gas.
Every 1-2 hours during the surgery
Sodium
Time Frame: Every 1-2 hours during the surgery
Sodium level from arterial blood gas.
Every 1-2 hours during the surgery
Ionized calcium
Time Frame: Every 1-2 hours during the surgery
Ionized calcium level from arterial blood gas.
Every 1-2 hours during the surgery
Potassium
Time Frame: Every 1-2 hours during the surgery
Potassium level from arterial blood gas.
Every 1-2 hours during the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fluid volume
Time Frame: Duration of surgery (approx. 4-6 hrs.)
Volume of fluid required for intraoperative resuscitation.
Duration of surgery (approx. 4-6 hrs.)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joseph D. Tobias

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

January 31, 2025

First Submitted That Met QC Criteria

February 6, 2025

First Posted (Actual)

February 12, 2025

Study Record Updates

Last Update Posted (Actual)

November 10, 2025

Last Update Submitted That Met QC Criteria

November 7, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00005116

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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