Joseph D. Tobias
Joseph D. Tobias
This is a prospective, randomized study in patients 8-21 years of age scheduled for an intracranial surgical procedure that requires invasive monitoring of arterial blood pressure. Subjects will be randomized to receive either 0.9% normal saline 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 for intraoperative resuscitation when using standard 0.9% saline or a novel buffered 2% saline solution.
Intracranial Central Nervous System Disorder
Neurologic Diseases, General
0.9 % NaCl
buffered 2% hypertonic saline
PHASE2
PHASE3
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 75 participants |
| Masking : | NONE |
| Primary Purpose : | TREATMENT |
| Official Title : | Use of a Buffered 2% Hypertonic Saline Solution During Intracranial Surgery |
| Actual Study Start Date : | 2025-06 |
| Estimated Primary Completion Date : | 2028-05 |
| Estimated Study Completion Date : | 2028-05 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 8 Years to 21 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
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Not yet recruiting
Nationwide Children's
Columbus, Ohio, United States, 43205