Water Load Test Value for Hyponatremia

Hyponatremia Clinical Trial

— WATERLINE  

Official title:

Water Load Test Value for Hyponatremia Due to a Syndrome of Inappropriate Antidiuresis (SIAD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04256499
• Other study ID #: WATERLINE
• Status: Completed
• Start date: January 1, 2001
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2020
• Source: European Georges Pompidou Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Acute water load test has been using to diagnose renal ability to excrete water for decades. Latest recommendations for the diagnosis of hyponatremia do not recommend performing such a test. The investigators aim at, retrospectively, study the value of acute water load test in patients suffering from a syndrome of inappropriate antidiuresis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• = 18 years old at the time of the test

• affiliated to a social insurance system

• water load test performed at the Renal and Metabolic Diseases Unit of the European George Pompidou Hospital, AP-HP, Paris, France

• between 01/01/2001 and 12/31/2019

Exclusion Criteria:

• hypernatremia and/or polyuria-polydipsia (diabetes insipidus)

• hyponatremia due to a tea and toast syndrome and/or a beer potomania

• hyponatremia due to a high (or normal) osmolality related to diabetes mellitus, hyperproteinemia and/or intoxication

• chronic kidney disease with an estimated glomerular filtration rate (eGFR) by the MDRD formula <60 mL/min/1.73m2

• hyponatremia related to thiazides

• hyponatremia related to an hypovolemic status

• syndrome of inappropriate antidiuresis related to an endocrine disorder (such as hypothyroidism or adrenal insufficiency)

Related Conditions & MeSH terms

• Hyponatremia
• Inappropriate ADH Syndrome
• SIAD - Syndrome of Inappropriate Antidiuresis
• Syndrome

Intervention

Procedure:
• Acute water load test
The acute water load test consists in administering orally 20 mL/kg (of body weight) of water (ingested in less than 30 min) and then follow (during 4 to 6 hours) blood and urine parameters.

Locations

Country	Name	City	State
France	European Georges Pompidou Hospital, APHP	Paris

Sponsors (1)

Lead Sponsor	Collaborator
European Georges Pompidou Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body weight	Variation of body weight during the test	Value at hour 6 versus initial value (hour 0)
Primary	Natremia	Plasma sodium concentration (abnormal if <135mM)	any time after water load test from hour 2 to hour 6
Secondary	Plasma osmolality	Plasma osmolality (abnormal if <280mOsm/kgH2O)	any time after water load test from hour 2 to hour 6
Secondary	Excretion of water load	Ratio between the excreted water (in urine) volume and the ingested one	after water load test from hour 0 to hour 6
Secondary	Urine osmolality	Minimum urine osmolality reached	any time after water load test from hour 2 to hour 6