A Low ChloridE hyperTonic Solution for Brain Edema (ACETATE)

April 27, 2023 updated by: Owen Samuels, Emory University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital's Neurointensive Care Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sodium chloride /sodium acetate (16.4%)
50cc doses of sodium-chloride/sodium-acetate (16.4%) along with 30cc bag of dummy solution (PlasmaLyte).
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.

Drug: PlasmaLyte
PlasmaLyte is an isotonic IV solution that mimics human physiological plasma electrolyte concentrations, osmolality and pH.
Other Names:
  • Placebo solution
Active Comparator: Sodium chloride (23.4%)
30cc per dose of sodium chloride (23.4%) along with 50cc dummy solution bag (PlasmaLyte)
Drug: PlasmaLyte
PlasmaLyte is an isotonic IV solution that mimics human physiological plasma electrolyte concentrations, osmolality and pH.
Other Names:
  • Placebo solution
Drug: Sodium chloride (23.4%)
Sodium Chloride is sterile, nonpyrogenic hypertonic saline (concentrated sodium-chloride) solution for parenteral (IV) fluid therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference between serum chloride level on randomization day and the peak afterwards
Time Frame: 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.
Baseline, up to once daily during a patient's stay in the ICU, and up to 90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with acute kidney injury (AKI)
Time Frame: 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.
Patients' stay in the ICU, and up to 90 days
All causes of in-hospital mortality.
Time Frame: 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.
Patients' stay in the ICU, and up to 90 days
All causes of 90 day mortality.
Time Frame: 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.
Up to 90 days
Change in intracerebral pressure (ICP) measured by ICP monitor following hypertonic treatment.
Time Frame: 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.
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.
Time Frame: 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.
Baseline, and daily during a patient's stay in the ICU, and up to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2017

Primary Completion (Actual)

September 30, 2018

Study Completion (Actual)

September 30, 2018

Study Registration Dates

First Submitted

June 28, 2017

First Submitted That Met QC Criteria

June 28, 2017

First Posted (Actual)

July 2, 2017

Study Record Updates

Last Update Posted (Actual)

May 1, 2023

Last Update Submitted That Met QC Criteria

April 27, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00090456

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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