A Phase 2/3 interventional study of Normosol-R and buffered 2% hypertonic saline in Scoliosis Idiopathic and Scoliosis;Congenital, sponsored by Joseph D. Tobias. Withdrawn at 1 site in United States. Open to participants aged 10 Years to 25 Years. Per ClinicalTrials.gov, last updated 2025-11-10.
Sponsored by Joseph D. Tobias · Phase 2/3, Interventional, and Treatment
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.
Joseph D. Tobias is the lead sponsor of 28 studies on the registry; 4 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Buffered 2% saline solution instead of standard of care isotonic fluid for fluid resuscitation during intraoperative care.
Drug: buffered 2% hypertonic saline
Isotonic solution of balanced electrolytes in water for fluid resuscitation during intraoperative care.
Drug: Normosol-R
Standard of care isotonic fluid.
A solution containing 2% sodium chloride (NaCl) that is "buffered" by the addition of another salt like sodium acetate.
pH
pH level from arterial blood gas.
Time frame: Every 1-2 hours during the surgery
Base deficit
Base deficit level from arterial blood gas.
Time frame: Every 1-2 hours during the surgery
Sodium
Sodium level from arterial blood gas.
Time frame: Every 1-2 hours during the surgery
Ionized calcium
Ionized calcium level from arterial blood gas.
Time frame: Every 1-2 hours during the surgery
Potassium
Potassium level from arterial blood gas.
Time frame: Every 1-2 hours during the surgery
Fluid volume
Volume of fluid required for intraoperative resuscitation.
Time frame: Duration of surgery (approx. 4-6 hrs.)
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Joseph D. Tobias