A Low ChloridE hyperTonic Solution for Brain Edema (ACETATE)

Emory University

Status and phase: Completed; Phase 1

Conditions: Subarachnoid Hemorrhage; Acute Kidney Injury

Treatments: Drug: PlasmaLyte; Drug: Sodium chloride (23.4%); Drug: Sodium chloride /sodium acetate (16.4%)

Study type: Interventional

Funder types: Other

Identifiers

NCT03204955

IRB00090456

Details and patient eligibility

About

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.

Full 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.

Enrollment: 59 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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59 participants in 2 patient groups

Sodium chloride /sodium acetate (16.4%)

Experimental group

Description:

50cc doses of sodium-chloride/sodium-acetate (16.4%) along with 30cc bag of dummy solution (PlasmaLyte).

Treatment:

Drug: Sodium chloride /sodium acetate (16.4%)

Drug: PlasmaLyte

Sodium chloride (23.4%)

Active Comparator group

Description:

30cc per dose of sodium chloride (23.4%) along with 50cc dummy solution bag (PlasmaLyte)

Treatment:

Drug: Sodium chloride (23.4%)

Drug: PlasmaLyte