A Low ChloridE hyperTonic Solution for Brain Edema

NCT03204955 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: IRB00090456
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Subarachnoid Hemorrhage; Acute Kidney Injury

Keywords

Osmolar therapy; Acetate

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (5)

• Number of patients with acute kidney injury (AKI)

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

• All causes of in-hospital mortality.

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

• All causes of 90 day mortality.

  Up to 90 days

• Change in intracerebral pressure (ICP) measured by ICP monitor following hypertonic treatment.

  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.

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

Study Arms (2)

Sodium chloride /sodium acetate (16.4%)

EXPERIMENTAL

50cc doses of sodium-chloride/sodium-acetate (16.4%) along with 30cc bag of dummy solution (PlasmaLyte).

Drug: Sodium chloride /sodium acetate (16.4%); Drug: PlasmaLyte

Sodium chloride (23.4%)

ACTIVE COMPARATOR

30cc per dose of sodium chloride (23.4%) along with 50cc dummy solution bag (PlasmaLyte)

Drug: Sodium chloride (23.4%); Drug: PlasmaLyte

Interventions

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 /sodium acetate (16.4%)

Sodium chloride (23.4%) DRUG

Sodium Chloride is sterile, nonpyrogenic hypertonic saline (concentrated sodium-chloride) solution for parenteral (IV) fluid therapy.

Sodium chloride (23.4%)

PlasmaLyte DRUG

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

Also known as: Placebo solution

Sodium chloride (23.4%); Sodium chloride /sodium acetate (16.4%)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University Hospital's Neurointensive Care Unit

Atlanta, Georgia, 30322, United States

Location

Related Publications (2)

• 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.

  PMID: 32391156 RESULT

• 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.

  PMID: 30428930 DERIVED

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Acute Kidney Injury

Interventions

Sodium Chloride; Sodium Acetate; Plasmalyte A

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Acetic Acid; Acetates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Owen Samuels, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 28, 2017
• First Posted: July 2, 2017
• Study Start: June 28, 2017
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: May 1, 2023

Record last verified: 2023-04

Locations

US (1)