Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2/PHASE3
INTERVENTIONAL
2025-12-31
2028-05-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Hypertonic saline
Buffered 2% saline solution instead of standard of care isotonic fluid for fluid resuscitation during intraoperative care.
buffered 2% hypertonic saline
A solution containing 2% sodium chloride (NaCl) that is "buffered" by the addition of another salt like sodium acetate.
Normosol-R
Isotonic solution of balanced electrolytes in water for fluid resuscitation during intraoperative care.
Normosol-R
Standard of care isotonic fluid.
Interventions
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Normosol-R
Standard of care isotonic fluid.
buffered 2% hypertonic saline
A solution containing 2% sodium chloride (NaCl) that is "buffered" by the addition of another salt like sodium acetate.
Eligibility Criteria
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Inclusion Criteria
* ASA 1-3
* Undergoing a PSF procedure requiring two peripheral intravenous infusions and an arterial cannula
Exclusion Criteria
* Two peripheral intravenous cannulas are not required
* An invasive arterial cannula cannot be placed
10 Years
25 Years
ALL
No
Sponsors
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Joseph D. Tobias
OTHER
Responsible Party
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Joseph D. Tobias
Chief, Department of Anesthesiology & Pain Medicine
Locations
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Nationwide Children's
Columbus, Ohio, United States
Countries
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Other Identifiers
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STUDY00005116
Identifier Type: -
Identifier Source: org_study_id
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