Water Load Test Value for Hyponatremia

NCT04256499 | Completed

• 1 other identifier: WATERLINE
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

SIAD - Syndrome of Inappropriate Antidiuresis; Hyponatremia

Keywords

hyponatremia; SIAD; water load test

Outcome Measures

Primary Outcomes (1)

• Natremia

  Plasma sodium concentration (abnormal if \<135mM)

  any time after water load test from hour 2 to hour 6

Secondary Outcomes (3)

• Plasma osmolality

  any time after water load test from hour 2 to hour 6

• Excretion of water load

  after water load test from hour 0 to hour 6

• Urine osmolality

  any time after water load test from hour 2 to hour 6

Other Outcomes (1)

• Body weight

  Value at hour 6 versus initial value (hour 0)

Study Arms (2)

Water load test

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

Procedure: Acute water load test

Control group

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

Procedure: Acute water load test

Interventions

Acute water load test PROCEDURE

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; Water load test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥ 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• European Georges Pompidou Hospital: lead

Study Sites (1)

European Georges Pompidou Hospital, APHP

Paris, 75908, France

Location

MeSH Terms

Conditions

Inappropriate ADH Syndrome; Hyponatremia

Condition Hierarchy (Ancestors)

Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jean-Philippe Bertocchio, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: February 5, 2020
• Study Start: January 1, 2001
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)