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Trial record 1 of 1 for:    03204955
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A Low ChloridE hyperTonic Solution for Brain Edema (ACETATE)

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ClinicalTrials.gov Identifier: NCT03204955
Recruitment Status : Completed
First Posted : July 2, 2017
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Owen Samuels, Emory University

Brief 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.

Condition or disease Intervention/treatment Phase
Subarachnoid Hemorrhage Acute Kidney Injury Drug: Sodium chloride /sodium acetate (16.4%) Drug: Sodium chloride (23.4%) Drug: PlasmaLyte Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Low-chloride Versus High-chloride Containing Hypertonic Solution for the Treatment of Subarachnoid Hemorrhage-Related Complications
Actual Study Start Date : June 28, 2017
Actual Primary Completion Date : September 30, 2018
Actual Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

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 Name: Placebo solution

Active Comparator: Sodium chloride (23.4%)
30cc per dose of sodium chloride (23.4%) along with 50cc dummy solution bag (PlasmaLyte)
Drug: Sodium chloride (23.4%)
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 Name: Placebo solution




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03204955


Locations
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United States, Georgia
Emory University Hospital's Neurointensive Care Unit
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Owen Samuels, MD Emory University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Owen Samuels, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT03204955     History of Changes
Other Study ID Numbers: IRB00090456
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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

Keywords provided by Owen Samuels, Emory University:
Osmolar therapy
Acetate

Additional relevant MeSH terms:
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Hemorrhage
Acute Kidney Injury
Subarachnoid Hemorrhage
Pathologic Processes
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Plasma-lyte 148
Pharmaceutical Solutions
Ophthalmic Solutions