Hypertonic Saline in Posterior Spinal Fusion

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

Status

Withdrawn

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06822374

Enrollment

Registered

2025-02-12

Start date

2025-12-31

Completion date

2028-05-31

Last updated

2025-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scoliosis;Congenital, Scoliosis Idiopathic

Keywords

intraoperative fluid resuscitation

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.

Interventions

DRUGNormosol-R

Standard of care isotonic fluid.

DRUGbuffered 2% hypertonic saline

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

10 Years to 25 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026