Evaluation of arginine-stimulating test for diagnosis of central diabetes insipidus

JRCT ID: jRCTs041220082

Registered date:26/10/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Central diabetes insipidus
• Date of first enrollment: 26/10/2022
• Target sample size: 50
• Study type: Interventional

Intervention(s)

Arginine stimulating test:
Arinine 0.5 g/kg (intervenous administration for 30 min)
Blood collection before administration and 30, 60, 90, and 120 min after start of administration
Total volume of blood collection: approximately 35 mL (7 mL each. 5 times)

Hypersaline test:
5% saline 0.05 mL/kg (intervenous administration at 0.05 mL/kg/min for 120 min)
Blood collection before administration and 30, 60, 90, and 120 min after start of administration
Total volume of blood collection: approximately 35 mL (7 mL each. 5 times)

Outcome(s)

• Primary Outcome: Sensitivity of arginine stimulating test in diagnosis of central diabetes insipidus

Secondary Outcome

Specificity of arginine stimulating test in diagnosis of central diabetes insipidus
Incidence of adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients below who consent to participate in this study in writing
1. Patients suspected as central diabetes insipidus
2. Patients already diagnosed as central diabetes insipidus
3. Patients with diencephalohypophysial diseases and no symptoms of diabetes insipidus

Exclude criteria

1. Patients with heart and renal failure
2. Patients with bronchial asthma
Pregnant or breastfeeding patients
3. Patients considered inappropriate for the participation in this study by doctors

Related Information

• Primary Sponsor: Arima Hiroshi