A Low ChloridE hyperTonic Solution for Brain Edema
Status: | Completed |
---|---|
Conditions: | Renal Impairment / Chronic Kidney Disease, Neurology |
Therapuetic Areas: | Nephrology / Urology, Neurology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/17/2018 |
Start Date: | June 28, 2017 |
End Date: | September 30, 2018 |
Low-chloride Versus High-chloride Containing Hypertonic Solution for the Treatment of Subarachnoid Hemorrhage-Related Complications
This pilot study will compare the two hypertonic solutions currently used for subarachnoid
hemorrhage (SAH) - related complications and to determine if the reduction of chloride load
is safer, and as efficacious as the classic hypertonic solution.
hemorrhage (SAH) - related complications and to determine if the reduction of chloride load
is safer, and as efficacious as the classic hypertonic solution.
This pilot study aimed to collect high-quality randomized and prospective information to help
plan a future, larger multicenter trial. The study will compare the two hypertonic solutions
currently used for subarachnoid hemorrhage (SAH) - related complications and to determine if
the reduction of chloride load by using a sodium acetate and sodium chloride mixture can lead
to a relative reduction of serum chloride, reduce kidney injury, and as efficacious as the
classic hypertonic solution.
Hyperosmolar therapy is one of the mainstay treatments for SAH-related cerebral edema and
vasospasm, in order to reduce delayed cerebral ischemia. Recent evidence from the literature
correlates high chloride load when applying IV fluids with worse outcome in a variety of
critically-ill patients. Hypertonic saline, with which most hyperosmolar treatment is done,
contains a supra-physiologic chloride load. It is possible that by changing the hypertonic
solution to a "chloride-lean" one, the study team would be able to reduce the side effects of
hypertonic sodium-chloride without losing its efficacy in treating SAH-related complications.
plan a future, larger multicenter trial. The study will compare the two hypertonic solutions
currently used for subarachnoid hemorrhage (SAH) - related complications and to determine if
the reduction of chloride load by using a sodium acetate and sodium chloride mixture can lead
to a relative reduction of serum chloride, reduce kidney injury, and as efficacious as the
classic hypertonic solution.
Hyperosmolar therapy is one of the mainstay treatments for SAH-related cerebral edema and
vasospasm, in order to reduce delayed cerebral ischemia. Recent evidence from the literature
correlates high chloride load when applying IV fluids with worse outcome in a variety of
critically-ill patients. Hypertonic saline, with which most hyperosmolar treatment is done,
contains a supra-physiologic chloride load. It is possible that by changing the hypertonic
solution to a "chloride-lean" one, the study team would be able to reduce the side effects of
hypertonic sodium-chloride without losing its efficacy in treating SAH-related complications.
Inclusion Criteria:
- Spontaneous SAH with an identified aneurysmal source as identified on neuroimaging
obtained at admission to Emory University Hospital or with imaging at an outside
hospital
- Age ≥ 18 years
Exclusion Criteria:
- SAH related to non-aneurysmal vascular anomaly
- SAH thought due to trauma
- SAH occurring in relation to another medical procedure (cardiac catheterization, LVAD
placement, etc.)
- SAH with a negative workup for cause ("angio-negative")
- Patients who arrive in a brain-death state or in a devastating clinical status that
will be presumed to lead to brain death or early withdrawal of treatment
- Patient who suffer from end-stage renal disease at baseline and who are routinely
treated with dialysis
- Known pregnancy
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