Efficacy and Safety of Rapid Intermittent Compared With Slow Continuous Correction in Severe Hyponatremia Patients

• Status: Completed
• Trial end date: 2019-09-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborator: National Research Foundation of Korea

Criteria

Inclusion Criteria:

• 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

• Moderately severe

:Nausea without vomiting Drowsy, Headache General weakness, myalgia

• Severe :Vomiting, Stupor, Seizures, Coma (Glasgow Coma Scale ≤8)

• written consent

Exclusion Criteria:

• Pseudohyponatremia: serum osmolality > 275 mOsm/kg

• If the serum osmolality is > 275 mOsm/kg but the BUN is ≥ 30 mg/dL, the patients can be registered if calculated serum osmolality (2 x plasma [Na] + [Glucose]/18) is <275 mOsm/kg

• Primary polydipsia: urine osmolality ≤ 100 mOsm/kg

• Glucose corrected serum sodium >125 mmol/L

• Arterial hypotension (SBP <90mmHg and MAP <70mmHg)

• Anuria or urinary outlet obstruction

• Liver disease

• 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