Comparison between DDAVP-treated and non-treated groups in severe hyponatremia

JRCT ID: jRCTs041220117

Registered date:16/01/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hyponatremia
• Date of first enrollment: 16/01/2023
• Target sample size: 66
• Study type: Interventional

Intervention(s)

1.Desmopressin-treated group
Desmopressin: 2 micrograms diluted in 20 mL or 50 mL of saline and administered intravenously slowly over 10 to 20 minutes, repeated every 8 hours, 3 times a day, until serum sodium level reaches 128 mEq/L and correction is completed.
3% saline: administered continuously at the rate assumed by the Adrogue-Madias method to increase serum sodium level by 6 mEq/L/d. The rate will be changed as needed with follow-up of blood tests until serum sodium level reaches 128 mEq/L and correction is completed.

2.non-treated group
Normal treatment.
Administer 3% saline solution for sodium loading and 5% dextrose solution for free water loading.

Outcome(s)

• Primary Outcome: Maximum delta serum sodium level at 24 hours

Secondary Outcome

Maximum delta serum sodium level at 48 hours
Safe sodium correction rate at 24 hours
Safe sodium correction rate at 48 hours
Safe sodium correction rate at each 24-hour period from start to 48 hours
The total volume of fluids administered
ICU length of stay
Length of hospital stay
Incidence of adverse effects

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Patients aged 20 years or older at the time of obtaining consent
2.Patients diagnosed with hyponatremia based on the diagnostic criteria of a sodium level of 120 mEq/L or less in blood tests
3.Patients who have given their free written consent to participate in this study after receiving sufficient explanation and understanding

Exclude criteria

1. Patients on regular DDAVP medication
2. Patients taking oral tolvaptan
3. Patients with hyponatremia diagnosed as isotonic or hypertonic
4. Patients diagnosed with hypotonic hyponatremia who are diagnosed with heart failure according to 2021ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure
5. Patients admitted towards other than ICU or ICU equivalent wards, and patients already hospitalized for other diseases
6. Other patients who are judged inappropriate by the principal investigator or sub-investigator

Related Information

• Primary Sponsor: Iwata Mitsunaga