WATERLINE: Water Load Test Value for Hyponatremia

Sponsor

European Georges Pompidou Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04256499

Collaborator

(none)

150

Enrollment

Location

227.9

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
SIAD - Syndrome of Inappropriate Antidiuresis Hyponatremia	Procedure: Acute water load test

Study Design

Study Type:

Observational

Actual Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2001

Actual Primary Completion Date :

Dec 31, 2019

Actual Study Completion Date :

Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Water load test Patients experiencing a syndrome of inappropriate antidiuresis who had an acute water load test	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.
Control group Patients who had an acute water load test and who did not experience any water homeostasis anomalies	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.

Arm

Intervention/Treatment

Water load test

Patients experiencing a syndrome of inappropriate antidiuresis who had an acute water load test

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.

Control group

Patients who had an acute water load test and who did not experience any water homeostasis anomalies

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.

Outcome Measures

Primary Outcome Measures

Natremia [any time after water load test from hour 2 to hour 6]
Plasma sodium concentration (abnormal if <135mM)

Secondary Outcome Measures

Plasma osmolality [any time after water load test from hour 2 to hour 6]
Plasma osmolality (abnormal if <280mOsm/kgH2O)
Excretion of water load [after water load test from hour 0 to hour 6]
Ratio between the excreted water (in urine) volume and the ingested one
Urine osmolality [any time after water load test from hour 2 to hour 6]
Minimum urine osmolality reached

Other Outcome Measures

Body weight [Value at hour 6 versus initial value (hour 0)]
Variation of body weight during the test

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)