SIAD - Syndrome of Inappropriate AntidiuresisWATERLINENCT04256499
Water Load Test Value for Hyponatremia
An observational study of SIAD - Syndrome of Inappropriate Antidiuresis and Hyponatremia, run by European Georges Pompidou Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SIAD - Syndrome of Inappropriate Antidiuresis, Hyponatremia
- What is being tested?
- Acute water load test
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2001to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- ≥ 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Acute water load test
- Keywords
- hyponatremia, SIAD, water load test
- Medical subject headings
- Inappropriate ADH Syndrome, Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute water load testProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Water load test | Patients experiencing a syndrome of inappropriate antidiuresis who had an acute water load test Receives: Procedure: Acute water load test | |
| Control group | Patients who had an acute water load test and who did not experience any water homeostasis anomalies Receives: Procedure: Acute water load test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Natremia
Plasma sodium concentration (abnormal if <135mM)
Measured: any time after water load test from hour 2 to hour 6
Secondary outcomes (3)
Plasma osmolality
Plasma osmolality (abnormal if <280mOsm/kgH2O)
Measured: 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
Measured: after water load test from hour 0 to hour 6
Urine osmolality
Minimum urine osmolality reached
Measured: any time after water load test from hour 2 to hour 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Jan 2001
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SIAD - Syndrome of Inappropriate AntidiuresisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Georges Pompidou Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-philippe Bertocchio, MD, PhD, European Georges Pompidou Hospital
- Investigators
- Jean-Philippe Bertocchio, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04256499
- Sponsor's protocol ID
- WATERLINE
- Acronym
- WATERLINE
- Status last verified
- Feb 2020
- First submitted
- 3 Feb 2020
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Water Load Test Value for Hyponatremia Due to a Syndrome of Inappropriate Antidiuresis (SIAD)
- ClinicalTrials.gov ID
- NCT04256499
- Acronym / sponsor ID
- WATERLINE / WATERLINE
- Keywords
- hyponatremia, SIAD, water load test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- European Georges Pompidou HospitalUniversity, hospital or other
- Study start
- 1 Jan 2001 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Water load test | – | Procedure: Acute water load testPatients experiencing a syndrome of inappropriate antidiuresis who had an acute water load test |
| Control group | – | Procedure: Acute water load testPatients who had an acute water load test and who did not experience any water homeostasis anomalies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- ≥ 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acute water load testThe 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. | Procedure or surgery | Control group, Water load test |
Primary outcome
Natremia
Time frame: any time after water load test from hour 2 to hour 6
Plasma sodium concentration (abnormal if <135mM)
3 secondary outcomes
Plasma osmolality
Time frame: any time after water load test from hour 2 to hour 6
Excretion of water load
Time frame: after water load test from hour 0 to hour 6
Urine osmolality
Time frame: any time after water load test from hour 2 to hour 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for SIAD - Syndrome of Inappropriate Antidiuresis
Recruiting
Urea for Treatment of Hyponatremia in Patients With SIAD Unresponsive to Fluid Restriction
SIAD - Syndrome of Inappropriate Antidiuresis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Philippe Bertocchio, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SIAD - Syndrome of Inappropriate Antidiuresis and Hyponatremia, run by European Georges Pompidou Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Natremia (time frame: any time after water load test from hour 2 to hour 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020; AzTrials last refreshed its copy on 28 Oct 2026.