A Low ChloridE hyperTonic Solution for Brain Edema

Acute Kidney Injury Clinical Trial

— ACETATE  

Official title:

Low-chloride Versus High-chloride Containing Hypertonic Solution for the Treatment of Subarachnoid Hemorrhage-Related Complications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03204955
• Other study ID #: IRB00090456
• Status: Completed
• Phase: Phase 1
• Start date: June 28, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: April 2023
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Hemorrhage
• Subarachnoid Hemorrhage

Intervention

Drug:
• Sodium 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.
• Sodium chloride (23.4%)
Sodium Chloride is sterile, nonpyrogenic hypertonic saline (concentrated sodium-chloride) solution for parenteral (IV) fluid therapy.
• PlasmaLyte
PlasmaLyte is an isotonic IV solution that mimics human physiological plasma electrolyte concentrations, osmolality and pH.

Locations

Country	Name	City	State
United States	Emory University Hospital's Neurointensive Care Unit	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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