Water Load Test Value for Hyponatremia (WATERLINE)

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

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.

Study Overview

• Status: Completed
• Conditions: Hyponatremia; SIAD - Syndrome of Inappropriate Antidiuresis
• Intervention / Treatment: Procedure: Acute water load test

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• France
  • Paris, France, 75908
    • European Georges Pompidou Hospital, APHP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

In this retrospective study, the included population is composed only with adult patients experiencing a syndrome of inappropriate antidiuresis (SIAD) who were explored by an acute water load test at the Renal and Metabolic Diseases Unit of the European George Pompidou Hospital, Paris, France.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Natremia	Plasma sodium concentration (abnormal if <135mM)	any time after water load test from hour 2 to hour 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma osmolality	Plasma osmolality (abnormal if <280mOsm/kgH2O)	any time after water load test from hour 2 to hour 6
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
Urine osmolality	Minimum urine osmolality reached	any time after water load test from hour 2 to hour 6

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight	Variation of body weight during the test	Value at hour 6 versus initial value (hour 0)

Collaborators and Investigators

• Sponsor: European Georges Pompidou Hospital
• Investigators: Principal Investigator: Jean-Philippe Bertocchio, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2001
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: February 3, 2020
• First Submitted That Met QC Criteria: February 4, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 4, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: hyponatremia; SIAD; water load test
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Disease; Hypothalamic Diseases; Pituitary Diseases; Water-Electrolyte Imbalance; Syndrome; Hyponatremia; Inappropriate ADH Syndrome
• Other Study ID Numbers: WATERLINE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No