This study will investigate efficacy and safety of rapid intermittent correction compared
with slow continuous correction with hypertonic saline in patient with moderately severe or
severe symptomatic severe hyponatremia
Drug: 3% hypertonic saline
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Full eligibility criteria for NCT02887469
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
In emergency setting (2016.6-) and/or inpatients at ward (2018.9-)
Glucose corrected serum sodium ≤125 mmol/L
Patients with moderately severe or severe symptom
:Nausea without vomiting Drowsy, Headache General weakness, myalgia
Severe :Vomiting, Stupor, Seizures, Coma (Glasgow Coma Scale ≤8)
Arterial hypotension (SBP <90mmHg and MAP <70mmHg)
Anuria or urinary outlet obstruction
transaminase levels >3 times the upper limit normal
Known LC with ascites or diuretics use or PSE Hx or Varix Hx
Uncontrolled diabetes mellitus (HbA1C > 9%)
Women who are pregnant or breast feeding
History of cardiac surgery excluding PCA, acute myocardial infarction, sustained ventricular tachycardia, ventricular fibrillation, acute coronary syndrome, cebrovascular trauma, and increased intracranial pressure within the 3 months prior to randomization
Seoul National University Bundang Hospital Clinical Trial Center
Seongnam, Gyeonggi-do, Korea, Republic of, 13605
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Seoul National University Boramae Hospital
Seoul, Korea, Republic of
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View full eligibility
Tris trial is registered with FDA with number: NCT02887469. The sponsor of the trial is Seoul National University Hospital and it is looking for 178 volunteers for the current phase.
Official trial title: Efficacy and Safety of Rapid Intermittent Correction Compared With Slow Continuous Correction With Hypertonic Saline in Patient With Moderately Severe or Severe Symptomatic Severe Hyponatremia (SALSA Trial)
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