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Subarachnoid HemorrhagePhase 1ACETATENCT03204955

A Low ChloridE hyperTonic Solution for Brain Edema

A Phase 1 study testing Sodium chloride /sodium acetate (16.4%), Sodium chloride (23.4%) and PlasmaLyte in people with Subarachnoid Hemorrhage and Acute Kidney Injury, run by Emory University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Subarachnoid Hemorrhage, Acute Kidney Injury
What is being tested?
Sodium chloride /sodium acetate (16.4%), Sodium chloride (23.4%) and PlasmaLyte
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
1 siteUnited States
Study dates
28 Jun 2017to 30 Sep 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Emory University Hospital's Neurointensive Care Unit

    Atlanta, Georgia, 30322

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Sodium chloride /sodium acetate (16.4%), Sodium chloride (23.4%), PlasmaLyte
Keywords
Osmolar therapy, Acetate
Medical subject headings
Subarachnoid Hemorrhage, Acute Kidney Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • PlasmaLyteDrug

    Also called Placebo solution

    PlasmaLyte is an isotonic IV solution that mimics human physiological plasma electrolyte concentrations, osmolality and pH.

Study groups in NCT03204955
Study groupRoleWhat they receive
Sodium chloride /sodium acetate (16.4%)Experimental50cc doses of sodium-chloride/sodium-acetate (16.4%) along with 30cc bag of dummy solution (PlasmaLyte).
Receives: Drug: Sodium chloride /sodium acetate (16.4%); Drug: PlasmaLyte
Sodium chloride (23.4%)Active comparator30cc per dose of sodium chloride (23.4%) along with 50cc dummy solution bag (PlasmaLyte)
Receives: Drug: Sodium chloride (23.4%); Drug: PlasmaLyte

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, up to once daily during a patient's stay in the ICU, and up to 90 days

Secondary outcomes (5)

  1. 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.

    Measured: Patients' stay in the ICU, and up to 90 days

  2. 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.

    Measured: Patients' stay in the ICU, and up to 90 days

  3. 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.

    Measured: Up to 90 days

  4. 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.

    Measured: Continuous measurement as long as the patient has an indication for an ICP monitor, and up to 90 days

  5. 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.

    Measured: Baseline, and daily during a patient's stay in the ICU, and up to 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2017
  2. Study start28 Jun 2017
  3. Primary completion30 Sep 2018
  4. Study completion30 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03204955
Sponsor's protocol ID
IRB00090456
Acronym
ACETATE
Status last verified
Apr 2023
First submitted
28 Jun 2017
Last updated
1 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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 complications: The ACETatE (A low ChloriE hyperTonic solution for brain Edema) randomized trial. J Intensive Care. 2020 May 4;8:32. doi: 10.1186/s40560-020-00449-0. eCollection 2020.

    PubMed 32391156

  • Sadan O, Samuels O, Asbury WH, Hanfelt JJ, Singbartl K. Low-chloride versus high-chloride hypertonic solution for the treatment of subarachnoid hemorrhage-related complications (The ACETatE trial): study protocol for a pilot randomized controlled trial. Trials. 2018 Nov 14;19(1):628. doi: 10.1186/s13063-018-3007-7.

    PubMed 30428930

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Sodium chloride /sodium acetate (16.4%), Sodium chloride (23.4%) and PlasmaLyte in people with Subarachnoid Hemorrhage and Acute Kidney Injury, run by Emory University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03204955, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2023.

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