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Completed

NCT Number: NCT03204955

A Low ChloridE hyperTonic Solution for Brain Edema

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Other names: Placebo solution

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

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

Acronym: ACETATE

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 2, 2017
Registry last updated
May 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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