Validation of the accuracy of a treatment prediction system for severe hyponatremia

JRCT ID: jRCTs042230147

Registered date:06/02/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Hyponatremia
• Date of first enrollment: 06/02/2024
• Target sample size: 24
• Study type: Interventional

Intervention(s)

Upon admission, the serum Na concentration, serum K concentration, serum Cl concentration, and the expected volume of drinking water up to 6 hours after the time of use of the prediction system are entered into the prediction system, and the predicted serum Na concentration at 6 hours is output as a table for each type of infusion and flow rate. The physician in charge of the patient selects the most appropriate type of infusion and flow rate from the table and administers treatment.
After 6 hours of hospitalization, the serum Na concentration, serum K concentration, serum Cl concentration, the expected amount of drinking water until 6 hours after the time of use of the prediction system, and the urine volume in the past 6 hours are input into the prediction system every 6 hours until 72 hours after admission, and the predicted serum Na concentration after 6 hours is output as a table for each type of infusion and flow rate. The physician in charge of the patient selects the most appropriate type of infusion and flow rate from the table and administers the treatment.

Outcome(s)

• Primary Outcome: Percentage of measured serum sodium concentration within +/- 2 mEq/L of the predicted serum sodium concentration at 12 hours after admission

Secondary Outcome

1. Percentage of measured serum sodium concentration within +/- 2 mEq/L of the predicted serum sodium concentration at 6 hours after admission
2. Percentage of measured serum sodium concentration within +/- 2 mEq/L of the predicted serum sodium concentration measured every 6 hours after 12 hours of admission
3. Accuracy of the prediction system for treatment of hyponatremia

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Patients who have given written consent and are undergoing inpatient treatment for correction of hyponatremia (serum sodium concentration <130 mEq/L) at Nagoya University Hospital, its affiliated facilities, and Gifu University Hospital.

Exclude criteria

1. Patients with urinary sodium concentration less than 20 mEq/L on admission
2. Patients taking high-dose steroids (hydrocortisone equivalent >30 mg/day) on admission
3. Patients who have used high-dose steroids (hydrocortisone equivalent >30 mg/day) after admission
4. Patients who used desmopressin or pitresin since admission

Related Information

• Primary Sponsor: Arima Hiroshi