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

A STudy of the AvailaBiLiity and Efficacy of DDAVP in Severe Hyponatremia treatment: A Randomized Controlled Trial - STABLE-HYPONATOREMIA study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs041220117
Enrollment
66
Registered
2023-01-16
Start date
2023-01-16
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyponatremia

Interventions

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 se

Sponsors

Iwata Mitsunaga
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Maximum delta serum sodium level at 24 hours

Secondary

MeasureTime frame
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

Contacts

Public ContactTeruhiko Terasawa

Fujita Health University Hospital

terasawa@fujita-hu.ac.jp+81-562-93-2355

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026