Hypertonic Saline in Posterior Spinal Fusion

Withdrawn before enrolling · Phase 2/Phase 3

Conditions studied: Scoliosis Idiopathic, Scoliosis;Congenital

In brief

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.

Key facts

Study ID

NCT06822374

Run by

Joseph D. Tobias

People needed

0

Starts

2025-12-01

Expected to finish

2028-05-01

Last updated by the study team

2025-11-10

Who can join

Age: 10 and older, up to 25. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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