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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

Tracking Information
First Submitted Date  ICMJE June 28, 2017
First Posted Date  ICMJE July 2, 2017
Last Update Posted Date October 15, 2018
Actual Study Start Date  ICMJE June 28, 2017
Actual Primary Completion Date September 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Low ChloridE hyperTonic Solution for Brain Edema
Official Title  ICMJE Low-chloride Versus High-chloride Containing Hypertonic Solution for the Treatment of Subarachnoid Hemorrhage-Related Complications
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Condition  ICMJE
  • Subarachnoid Hemorrhage
  • Acute Kidney Injury
Intervention  ICMJE
  • 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: 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
Study Arms  ICMJE
  • Experimental: Sodium chloride /sodium acetate (16.4%)
    50cc doses of sodium-chloride/sodium-acetate (16.4%) along with 30cc bag of dummy solution (PlasmaLyte).
    Interventions:
    • Drug: Sodium chloride /sodium acetate (16.4%)
    • Drug: PlasmaLyte
  • Active Comparator: Sodium chloride (23.4%)
    30cc per dose of sodium chloride (23.4%) along with 50cc dummy solution bag (PlasmaLyte)
    Interventions:
    • Drug: Sodium chloride (23.4%)
    • Drug: PlasmaLyte
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 12, 2018)
59
Original Estimated Enrollment  ICMJE
 (submitted: June 28, 2017)
80
Actual Study Completion Date  ICMJE September 30, 2018
Actual Primary Completion Date September 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03204955
Other Study ID Numbers  ICMJE IRB00090456
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Owen Samuels, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Owen Samuels, MD Emory University
PRS Account Emory University
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP