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Completed

NCT Number: NCT04256499

Water Load Test Value for Hyponatremia

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.

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Key information

Conditions

SIAD - Syndrome of Inappropriate Antidiuresis Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hyponatremia Hypothalamic Diseases Inappropriate ADH Syndrome Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Pituitary Diseases Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

European Georges Pompidou Hospital, APHP

Paris, 75908, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Natremia

    Time frame: any time after water load test from hour 2 to hour 6

    Plasma sodium concentration (abnormal if <135mM)

Secondary outcomes

  1. Plasma osmolality

    Time frame: any time after water load test from hour 2 to hour 6

    Plasma osmolality (abnormal if <280mOsm/kgH2O)

  2. Excretion of water load

    Time frame: after water load test from hour 0 to hour 6

    Ratio between the excreted water (in urine) volume and the ingested one

  3. Urine osmolality

    Time frame: any time after water load test from hour 2 to hour 6

    Minimum urine osmolality reached

Other outcomes

  1. Body weight

    Time frame: Value at hour 6 versus initial value (hour 0)

    Variation of body weight during the test

Sponsors and collaborators

Lead sponsor

European Georges Pompidou Hospital

Other

Registry information

Official study title

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

Acronym: WATERLINE

Important dates

Study start
2001
Primary completion
2019
Study completion
2019
First posted
Feb 5, 2020
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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