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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypertonic saline | Experimental | Buffered 2% saline solution instead of standard of care isotonic fluid for fluid resuscitation during intraoperative care. |
|
| Normosol-R | Active Comparator | Isotonic solution of balanced electrolytes in water for fluid resuscitation during intraoperative care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normosol-R | Drug | Standard of care isotonic fluid. |
| |
| buffered 2% hypertonic saline |
| Measure | Description | Time Frame |
|---|---|---|
| pH | pH level from arterial blood gas. | Every 1-2 hours during the surgery |
| Base deficit | Base deficit level from arterial blood gas. | Every 1-2 hours during the surgery |
| Sodium | Sodium level from arterial blood gas. | Every 1-2 hours during the surgery |
| Ionized calcium | Ionized calcium level from arterial blood gas. | Every 1-2 hours during the surgery |
| Potassium | Potassium level from arterial blood gas. | Every 1-2 hours during the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Fluid volume | Volume of fluid required for intraoperative resuscitation. | Duration of surgery (approx. 4-6 hrs.) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's | Columbus | Ohio | 43205 | United States |
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| ID | Term |
|---|---|
| C048013 | Plasmalyte A |
| D000665 | Ampholyte Mixtures |
| D012462 | Saline Solution, Hypertonic |
| ID | Term |
|---|---|
| D002021 | Buffers |
| D019995 | Laboratory Chemicals |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
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| Drug |
A solution containing 2% sodium chloride (NaCl) that is "buffered" by the addition of another salt like sodium acetate. |
|
| D006982 |
| Hypertonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |