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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium chloride /sodium acetate (16.4%) | Experimental | 50cc doses of sodium-chloride/sodium-acetate (16.4%) along with 30cc bag of dummy solution (PlasmaLyte). |
|
| Sodium chloride (23.4%) | Active Comparator | 30cc per dose of sodium chloride (23.4%) along with 50cc dummy solution bag (PlasmaLyte) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium chloride /sodium acetate (16.4%) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between serum chloride level on randomization day and the peak afterwards | 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. | Baseline, up to once daily during a patient's stay in the ICU, and up to 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with acute kidney injury (AKI) | 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. | Patients' stay in the ICU, and up to 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Owen Samuels, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital's Neurointensive Care Unit | Atlanta | Georgia | 30322 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32391156 | Result | Sadan O, Singbartl K, Kraft J, Plancher JM, Greven ACM, Kandiah P, Pimentel C, Hall CL, Papangelou A, Asbury WH, Hanfelt JJ, Samuels O. Low-chloride- versus high-chloride-containing hypertonic solution for the treatment of subarachnoid hemorrhage-related complications: The ACETatE (A low ChloriE hyperTonic solution for brain Edema) randomized trial. J Intensive Care. 2020 May 4;8:32. doi: 10.1186/s40560-020-00449-0. eCollection 2020. | |
| 30428930 |
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| ID | Term |
|---|---|
| D013345 | Subarachnoid Hemorrhage |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D019346 | Sodium Acetate |
| C048013 | Plasmalyte A |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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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.
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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.
|
| Sodium chloride (23.4%) | Drug | Sodium Chloride is sterile, nonpyrogenic hypertonic saline (concentrated sodium-chloride) solution for parenteral (IV) fluid therapy. |
|
| PlasmaLyte | Drug | PlasmaLyte is an isotonic IV solution that mimics human physiological plasma electrolyte concentrations, osmolality and pH. |
|
|
| All causes of in-hospital mortality. | All causes of in-hospital mortality, including withdrawal of treatment or discharge to a hospice facility, will be recorded. | Patients' stay in the ICU, and up to 90 days |
| All causes of 90 day mortality. | All causes of mortality, 90 days post admission day, including withdrawal of treatment or discharge to a hospice facility, will be recorded. | Up to 90 days |
| Change in intracerebral pressure (ICP) measured by ICP monitor following hypertonic treatment. | Change in intracerebral pressure (ICP) following the administration of the hypertonic solution will be recorded. | Continuous measurement as long as the patient has an indication for an ICP monitor, and up to 90 days |
| Change in serum sodium level following the administration of the hypertonic solution. | 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. | Baseline, and daily during a patient's stay in the ICU, and up to 90 days |
| Derived |
| Sadan O, Samuels O, Asbury WH, Hanfelt JJ, Singbartl K. Low-chloride versus high-chloride hypertonic solution for the treatment of subarachnoid hemorrhage-related complications (The ACETatE trial): study protocol for a pilot randomized controlled trial. Trials. 2018 Nov 14;19(1):628. doi: 10.1186/s13063-018-3007-7. |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D017670 |
| Sodium Compounds |
| D019342 | Acetic Acid |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |