Overview

Hypertonic Saline in Posterior Spinal Fusion

Status:
NOT_YET_RECRUITING
Trial end date:
2028-05-01
Target enrollment:
Participant gender:
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.
Phase:
PHASE2
Details
Lead Sponsor:
Joseph D. Tobias
Treatments:
Ampholyte Mixtures
Plasmalyte A
Saline Solution, Hypertonic