Hypertonic Saline in Posterior Spinal Fusion

Joseph D. Tobias

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Scoliosis;Congenital; Scoliosis Idiopathic

Treatments: Drug: Normosol-R; Drug: buffered 2% hypertonic saline

Study type: Interventional

Funder types: Other

Identifiers

NCT06822374

STUDY00005116

Details and patient eligibility

About

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.

Sex: All

Ages: 10 to 25 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Hypertonic saline

Experimental group

Description:

Buffered 2% saline solution instead of standard of care isotonic fluid for fluid resuscitation during intraoperative care.

Treatment:

Drug: buffered 2% hypertonic saline

Normosol-R

Active Comparator group

Description:

Isotonic solution of balanced electrolytes in water for fluid resuscitation during intraoperative care.

Treatment:

Drug: Normosol-R