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Efficacy of Oral Urea Supplementation in Patients With SIAD Not Adequately Controlled With Fluid Restriction

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Hyponatremia due to SIAD is frequently insufficiently corrected by fluid restriction alone, which remains the first-line therapy but is often poorly tolerated. Urea supplementation is recommended as second-line therapy. This prospective study evaluates the effectiveness of oral urea supplementation in patients with chronic SIAD and persistent hyponatremia despite fluid restriction.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Confirmed diagnosis of SIAD established prior to study inclusion, defined as:

• Plasma sodium concentration \<135 mmol/L

• Plasma osmolality \<300 mOsm/kg

• Urine osmolality \>100 mOsm/kg

• Urine sodium concentration \>30 mmol/L

• Intact adrenal and thyroidal function and no use of diuretics in the last 4 weeks

• Clinical euvolemia, defined as an absence of signs of hypovolemia (orthostasis, tachycardia, decreased skin turgor, dry mucous membranes) or hypervolemia (edema, ascites)

⁃ Fulfillment of all diagnostic criteria at baseline (day 0) was not mandatory, as the diagnosis of SIAD had already been established prior to study inclusion based on overall clinical assessment.

⁃ \- Written informed consent obtained

Locations
Other Locations
Italy
AOU Città della Salute e della Scienza
RECRUITING
Turin
Time Frame
Start Date: 2024-09-12
Estimated Completion Date: 2027-12
Participants
Target number of participants: 20
Treatments
Experimental: Urea therapy
Participants will receive oral urea supplementation for 42±4 days, followed by a 10±2-day washout period
Related Therapeutic Areas
Sponsors
Leads: University of Turin, Italy

This content was sourced from clinicaltrials.gov

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