Subarachnoid Hemorrhage, Acute Kidney Injury
Conditions
Keywords
Osmolar therapy, Acetate
Brief summary
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.
Detailed description
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.
Interventions
DRUGSodium chloride /sodium acetate (16.4%)
Sodium Acetate is a sterile, nonpyrogenic solution of Sodium Acetate intended as an alternative to sodium chloride to provide sodium ion in parenteral (IV) fluid therapy. Sodium Chloride is sterile, nonpyrogenic hypertonic saline (concentrated sodium-chloride) solution for parenteral (IV) fluid therapy.
DRUGSodium chloride (23.4%)
Sodium Chloride is sterile, nonpyrogenic hypertonic saline (concentrated sodium-chloride) solution for parenteral (IV) fluid therapy.
DRUGPlasmaLyte
PlasmaLyte is an isotonic IV solution that mimics human physiological plasma electrolyte concentrations, osmolality and pH.
Sponsors
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
A double-blinded-double-dummy design, where each dose of hypertonic solution will be administered along with a balanced solution in order to mask the difference in the volume between the two solutions.
Intervention model description
Once consented to the study, patients' serum chloride will be followed daily. Patients who will have a chloride concentration of 109mg/dL or above will be randomized to receive the blinded hypertonic solutions.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference between serum chloride level on randomization day and the peak afterwards | Baseline, up to once daily during a patient's stay in the ICU, and up to 90 days | Serum chloride levels will be measured as part of standard of care. Difference between serum chloride level on randomization day and the peak afterwards will be calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with acute kidney injury (AKI) | Patients' stay in the ICU, and up to 90 days | AKI diagnosis will be done on the basis of clinical parameters (serum creatinine ≥ 1.5 times baseline or ≥0.3 mg/dl and urine output (\<0.5 ml/kg/h for 6 hours) according to Kidney Disease Improving Global Outcomes (KDIGO). Number of patients with acute kidney injury (AKI) will be recorded. |
| All causes of in-hospital mortality. | Patients' stay in the ICU, and up to 90 days | All causes of in-hospital mortality, including withdrawal of treatment or discharge to a hospice facility, will be recorded. |
| All causes of 90 day mortality. | Up to 90 days | All causes of mortality, 90 days post admission day, including withdrawal of treatment or discharge to a hospice facility, will be recorded. |
| Change in intracerebral pressure (ICP) measured by ICP monitor following hypertonic treatment. | Continuous measurement as long as the patient has an indication for an ICP monitor, and up to 90 days | Change in intracerebral pressure (ICP) following the administration of the hypertonic solution will be recorded. |
| Change in serum sodium level following the administration of the hypertonic solution. | Baseline, and daily during a patient's stay in the ICU, and up to 90 days | Serum sodium levels will be measured as part of standard of care. Difference between serum sodium level on randomization day and the peak afterwards will be calculated. |
Countries
United States
Outcome results
None listed