drugset / Trial / NCT06822374

Hypertonic Saline in Posterior Spinal Fusion

NCT06822374

Phase 2/3 Withdrawn Joseph D. Tobias
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2025-12
Primary completion
2028-05
Completion
2028-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Normosol-R Unknown
Subject buffered 2% hypertonic saline Unknown

Indications