Diabetes InsipidusCARGOxNCT03572166
Use of Copeptin Measurement After Arginine Infusion for the Differential Diagnosis of Diabetes Insipidus - the CARGOx Study
A study testing Arginine infusion and Hypertonic saline infusion in people with Diabetes Insipidus and Polydipsia, Primary, run by University Hospital, Basel, Switzerland at 7 sites in 6 countries.
Trial summary
The differential diagnosis of central diabetes insipidus (cDI) is difficult and the current test with the highest diagnostic accuracy is copeptin measurement after hypertonic saline infusion (HIS). Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Diabetes Insipidus, Polydipsia, Primary
- What is being tested?
- Arginine infusion and Hypertonic saline infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 7 sitesin 6 countries
- Study dates
- 3 Sep 2018to 31 Dec 2022
- Phase
- Interventional
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Hypotonic polyuria / polydipsia syndrome defined as: polyuria >50ml/kg body weight/24h and polydipsia >3l /24h or known diabetes insipidus under treatment with DDAVP
- Urine-Osmolality <800mOsm/L
Who cannot join
- Polyuria / polydipsia secondary to diabetes mellitus, hypercalcemia or hypokalemia
- Nephrogenic diabetes insipidus (defined as baseline copeptin level >21.4pmol/L)
- Evidence of any acute illness
- Epilepsy requiring treatment
- Uncontrolled arterial hypertension (blood pressure >160/100mmHg at baseline)
- Cardiac failure (NYHA III-IV)
Show all 11Show fewer
- Liver cirrhosis (Child B-C)
- Uncorrected adrenal or thyroidal deficiency
- Patients refusing or unable to give written informed consent
- Pregnancy or breast feeding
- End of life care
Trial locations and contacts
7 sites in 6 countries.
7 sites in 6 countries
Switzerland2 sites
University Hospital Basel, Department of Endocrinology
Basel, Canton of Basel-City, 4031
University Hospital Zurich
Zurich
About this study
The differential diagnosis of central diabetes insipidus (cDI) is difficult and the current test with the highest diagnostic accuracy is copeptin measurement after hypertonic saline infusion (HIS). Although the HIS improved diagnostic accuracy compared to the standard water deprivation test used for decades before, it still comprises great discomfort for patients due to the rise in serum sodium levels above 149mmol/l and requires the presence of medical staff at all times to guarantee safety of the test.
The arginine stimulation test is routinely used to stimulate growth hormone. Own data in 52 patients with polyuria / polydipsia syndrome showed that arginine infusion is a potent stimulator of the neurohypophysis and provides a new diagnostic tool in the differential diagnosis of cDI. Copeptin measurements upon arginine stimulation (CAS) discriminated patients with diabetes insipidus vs. patients with primary polydipsia with a high diagnostic accuracy of 94%.
To validate these results and to compare them against the HIS a large multicenter trial is needed, where the diagnostic accuracy of the CAS is compared to the HIS.
- Conditions
- Diabetes Insipidus, Polydipsia, Primary
- Being tested
- Arginine infusion, Hypertonic saline infusion
- Keywords
- Copeptin
- Medical subject headings
- Diabetes Insipidus, Polydipsia, Psychogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arginine infusionDiagnostic test
Intravenous Infusion of Arginine is given, copeptin measurement will be collected before and 60minutes after start of infusion
Hypertonic saline infusionDiagnostic test
Intravenous Infusion of hypertonic Saline is given, copeptin measurement will be collected before and once Plasma sodium rises above 149mmol/l
| Study group | Role | What they receive |
|---|---|---|
| Arginine Infusion | Experimental | Arginine Stimulation Test Receives: Diagnostic Test: Arginine infusion |
| Hypertonic saline infusion | Active comparator | Hypertonic Saline Infusion Test Receives: Diagnostic Test: Hypertonic saline infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the overall diagnostic accuracy - defined as the proportion of correct diagnoses - of each diagnostic procedure in differentiating patients with central diabetes insipidus from patients with primary polydipsia.
For Arginine stimulation the copeptin cut-off to differentiate between diabetes insipidus and primary polydipsia will be 3.8 pmol/l after 60 minutes, for hypertonic saline stimulation it will be the copeptin cut-off 4.9 pmol/l taken at the end of the test
Measured: 2 days
Secondary outcomes (19)
Sensitivity of both diagnostic procedures for each diagnosis (Primary polydipsia, partial and complete central Diabetes insipidus) according to recommended diagnostic test criteria and previously generated cutoff values
Copeptin cut-offs used:
Arginine stimulation:
- Copeptin level at 60 minutes < 2.4 pmol/l = complete central diabetes insipidus
- Copeptin level at 60 minutes 2.4 - 3.8 pmol/l = partial central diabetes insipidus
- Copeptin level at 60 minutes > 3.8 pmol/l = primary polydipsia
Hypertonic saline stimulation:
- Copeptin level < 2.7 pmol/l = complete central diabetes insipidus
- Copeptin level 2.7 - 4.9 pmol/l = partial central diabetes insipidus
- Copeptin level > 4.9 pmol/l = primary polydipsia
Measured: 2 days (1 day for each test, evaluation diagnostic accuracy at end of trial)
Specificity of both diagnostic procedures for each diagnosis (Primary polydipsia, partial and complete central Diabetes insipidus) according to recommended diagnostic test criteria and previously generated cutoff values
Copeptin cut-offs used:
Arginine stimulation:
- Copeptin level at 60 minutes < 2.4 pmol/l = complete central diabetes insipidus
- Copeptin level at 60 minutes 2.4 - 3.8 pmol/l = partial central diabetes insipidus
- Copeptin level at 60 minutes > 3.8 pmol/l = primary polydipsia
Hypertonic saline stimulation:
- Copeptin level < 2.7 pmol/l = complete central diabetes insipidus
- Copeptin level 2.7 - 4.9 pmol/l = partial central diabetes insipidus
- Copeptin level > 4.9 pmol/l = primary polydipsia
Measured: 2 days (1 day for each test, evaluation diagnostic accuracy at end of trial)
Positive predictive value of both diagnostic procedures for each diagnosis (Primary polydipsia, partial and complete central Diabetes insipidus) according to recommended diagnostic test criteria and previously generated cutoff values
Copeptin cut-offs used:
Arginine stimulation:
- Copeptin level at 60 minutes < 2.4 pmol/l = complete central diabetes insipidus
- Copeptin level at 60 minutes 2.4 - 3.8 pmol/l = partial central diabetes insipidus
- Copeptin level at 60 minutes > 3.8 pmol/l = primary polydipsia
Hypertonic saline stimulation:
- Copeptin level < 2.7 pmol/l = complete central diabetes insipidus
- Copeptin level 2.7 - 4.9 pmol/l = partial central diabetes insipidus
- Copeptin level > 4.9 pmol/l = primary polydipsia
Measured: 2 days (1 day for each test, evaluation diagnostic accuracy at end of trial)
Negative predictive value of both diagnostic procedures for each diagnosis (Primary polydipsia, partial and complete central Diabetes insipidus) according to recommended diagnostic test criteria and previously generated cutoff values
Copeptin cut-offs used:
Arginine stimulation:
- Copeptin level at 60 minutes < 2.4 pmol/l = complete central diabetes insipidus
- Copeptin level at 60 minutes 2.4 - 3.8 pmol/l = partial central diabetes insipidus
- Copeptin level at 60 minutes > 3.8 pmol/l = primary polydipsia
Hypertonic saline stimulation:
- Copeptin level < 2.7 pmol/l = complete central diabetes insipidus
- Copeptin level 2.7 - 4.9 pmol/l = partial central diabetes insipidus
- Copeptin level > 4.9 pmol/l = primary polydipsia
Measured: 2 days (1 day for each test, evaluation diagnostic accuracy at end of trial)
Best fit diagnostic copeptin cut-off values for differentiation between each diagnosis (Primary polydipsia, partial and complete central Diabetes insipidus) upon arginine stimulation and hypertonic saline infusion stimulation
Measured: 2 days (1 day for each test, evaluation diagnostic accuracy at end of trial)
Accuracy of the copeptin cut-off of 3.7 pmol/l after 60 minutes and 4.1 after 90 minutes for Arginine Stimulation test
Measured: 2 days (1 day for each test, evaluation diagnostic accuracy at end of trial)
Sensitivity of the copeptin cut-off of 3.7 pmol/l after 60 minutes and 4.1 after 90 minutes for Arginine Stimulation test
Measured: 2 days (1 day for each test, evaluation diagnostic accuracy at end of trial)
Specificity of the copeptin cut-off of 3.7 pmol/l after 60 minutes and 4.1 after 90 minutes for Arginine Stimulation test
Measured: 2 days (1 day for each test, evaluation diagnostic accuracy at end of trial)
Accuracy of the copeptin cut-off of 6.5 pmol/l for Hypertonic Saline Infusion test
Measured: 2 days (1 day for each test, evaluation diagnostic accuracy at end of trial)
Sensitivity of the copeptin cut-off of 6.5 pmol/l for Hypertonic Saline Infusion test
Measured: 2 days (1 day for each test, evaluation diagnostic accuracy at end of trial)
Specificity of the copeptin cut-off of 6.5 pmol/l for Hypertonic Saline Infusion test
Measured: 2 days (1 day for each test, evaluation diagnostic accuracy at end of trial)
Frequency and severity of thirst assessed by visual analogue scale during both tests
assessed by visual analogue scale from 0 to 10, with 0 indicating no symptoms and 10 indicating severe symptoms.
Measured: 2 days (1 for each test)
Frequency and severity of headache assessed by visual analogue scale during both tests
assessed by visual analogue scale from 0 to 10, with 0 indicating no symptoms and 10 indicating severe symptoms.
Measured: 2 days (1 for each test)
Frequency and severity of nausea assessed by visual analogue scale during both tests
assessed by visual analogue scale from 0 to 10, with 0 indicating no symptoms and 10 indicating severe symptoms.
Measured: 2 days (1 for each test)
Frequency and severity of vertigo assessed by visual analogue scale during both tests
assessed by visual analogue scale from 0 to 10, with 0 indicating no symptoms and 10 indicating severe symptoms.
Measured: 2 days (1 for each test)
Frequency and severity of general malaise assessed by visual analogue scale during both tests
assessed by visual analogue scale from 0 to 10, with 0 indicating no symptoms and 10 indicating severe symptoms.
Measured: 2 days (1 for each test)
Subjective burden assessed by visual analogue scale of both tests
assessed by visual analogue scale from 0 to 10, with 0 indicating no symptoms and 10 indicating severe symptoms.
Measured: 2 days (1 for each test)
Health care costs of both tests
Measured: 2 days (1 for each test)
Frequency of test preference at follow up visit
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study start3 Sep 2018
- Primary completion30 Sep 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes InsipidusStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Observational randomized cross-over diagnostic international multicenter study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Zürich, Wuerzburg University Hospital, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Erasmus Medical Center, Cambridge University Hospitals NHS Foundation Trust, Federal University of Minas Gerais
- Responsible party
- Sponsor
- Investigators
- Mirjam Christ-Crain, Prof, MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03572166
- Sponsor's protocol ID
- CARGOx
- Acronym
- CARGOx
- Status last verified
- Jul 2023
- First submitted
- 4 Jun 2018
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Atila C, Chifu I, Drummond JB, Vogt DR, Nahum U, Fassnacht M, Winzeler B, Refardt J, Christ-Crain M. A novel diagnostic score for diagnosing arginine vasopressin deficiency (central diabetes insipidus) or primary polydipsia with basal laboratory and clinical parameters: results from two international multicentre prospective diagnostic studies. Lancet Diabetes Endocrinol. 2025 Jun;13(6):505-515. doi: 10.1016/S2213-8587(25)00053-1. Epub 2025 Apr 25.
PubMed 40294614Bizzozero CA, Monnerat S, Chapman FA, Dhaun N, Refardt J, Christ-Crain M. Apelin levels in patients with polyuria-polydipsia syndrome upon copeptin stimulation tests. Eur J Endocrinol. 2024 Oct 29;191(5):491-498. doi: 10.1093/ejendo/lvae138.
PubMed 39425917Refardt J, Atila C, Chifu I, Ferrante E, Erlic Z, Drummond JB, Indirli R, Drexhage RC, Sailer CO, Widmer A, Felder S, Powlson AS, Hutter N, Vogt DR, Gurnell M, Soares BS, Hofland J, Beuschlein F, Fassnacht M, Winzeler B, Christ-Crain M. Arginine or Hypertonic Saline-Stimulated Copeptin to Diagnose AVP Deficiency. N Engl J Med. 2023 Nov 16;389(20):1877-1887. doi: 10.1056/NEJMoa2306263.
PubMed 37966286
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Copeptin Measurement After Arginine Infusion for the Differential Diagnosis of Diabetes Insipidus - the CARGOx Study
- ClinicalTrials.gov ID
- NCT03572166
- Acronym / sponsor ID
- CARGOx / CARGOx
- Conditions
- Diabetes Insipidus, Polydipsia, Primary
- Keywords
- Copeptin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- University Hospital, Zürich, Wuerzburg University Hospital, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Erasmus Medical Center, Cambridge University Hospitals NHS Foundation Trust, Federal University of Minas Gerais
- Study start
- 3 Sep 2018 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 28 Jun 2018 (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.
The differential diagnosis of central diabetes insipidus (cDI) is difficult and the current test with the highest diagnostic accuracy is copeptin measurement after hypertonic saline infusion (HIS). Although the HIS improved diagnostic accuracy compared to the standard water deprivation test used for decades before, it still comprises great discomfort for patients due to the rise in serum sodium levels above 149mmol/l and requires the presence of medical staff at all times to guarantee safety of the test.
The arginine stimulation test is routinely used to stimulate growth hormone. Own data in 52 patients with polyuria / polydipsia syndrome showed that arginine infusion is a potent stimulator of the neurohypophysis and provides a new diagnostic tool in the differential diagnosis of cDI. Copeptin measurements upon arginine stimulation (CAS) discriminated patients with diabetes insipidus vs. patients with primary polydipsia with a high diagnostic accuracy of 94%.
To validate these results and to compare them against the HIS a large multicenter trial is needed, where the diagnostic accuracy of the CAS is compared to the HIS.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Observational randomized cross-over diagnostic international multicenter study
| Arm | Type | Receives |
|---|---|---|
| Arginine Infusion | Experimental | Diagnostic Test: Arginine infusionArginine Stimulation Test |
| Hypertonic saline infusion | Active comparator | Diagnostic Test: Hypertonic saline infusionHypertonic Saline Infusion Test |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Hypotonic polyuria / polydipsia syndrome defined as: polyuria >50ml/kg body weight/24h and polydipsia >3l /24h or known diabetes insipidus under treatment with DDAVP
- Urine-Osmolality <800mOsm/L
Key exclusion criteria (11 listed)
- Polyuria / polydipsia secondary to diabetes mellitus, hypercalcemia or hypokalemia
- Nephrogenic diabetes insipidus (defined as baseline copeptin level >21.4pmol/L)
- Evidence of any acute illness
- Epilepsy requiring treatment
- Uncontrolled arterial hypertension (blood pressure >160/100mmHg at baseline)
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 |
|---|---|---|
| Arginine infusionIntravenous Infusion of Arginine is given, copeptin measurement will be collected before and 60minutes after start of infusion | Diagnostic test | Arginine Infusion |
| Hypertonic saline infusionIntravenous Infusion of hypertonic Saline is given, copeptin measurement will be collected before and once Plasma sodium rises above 149mmol/l | Diagnostic test | Hypertonic saline infusion |
Primary outcome
The primary outcome is the overall diagnostic accuracy - defined as the proportion of correct diagnoses - of each diagnostic procedure in differentiating patients with central diabetes insipidus from patients with primary polydipsia.
Time frame: 2 days
For Arginine stimulation the copeptin cut-off to differentiate between diabetes insipidus and primary polydipsia will be 3.8 pmol/l after 60 minutes, for hypertonic saline stimulation it will be the copeptin cut-off 4.9 pmol/l taken at the end of the test
19 secondary outcomes
Sensitivity of both diagnostic procedures for each diagnosis (Primary polydipsia, partial and complete central Diabetes insipidus) according to recommended diagnostic test criteria and previously generated cutoff values
Time frame: 2 days (1 day for each test, evaluation diagnostic accuracy at end of trial)
Specificity of both diagnostic procedures for each diagnosis (Primary polydipsia, partial and complete central Diabetes insipidus) according to recommended diagnostic test criteria and previously generated cutoff values
Time frame: 2 days (1 day for each test, evaluation diagnostic accuracy at end of trial)
Positive predictive value of both diagnostic procedures for each diagnosis (Primary polydipsia, partial and complete central Diabetes insipidus) according to recommended diagnostic test criteria and previously generated cutoff values
Time frame: 2 days (1 day for each test, evaluation diagnostic accuracy at end of trial)
Negative predictive value of both diagnostic procedures for each diagnosis (Primary polydipsia, partial and complete central Diabetes insipidus) according to recommended diagnostic test criteria and previously generated cutoff values
Time frame: 2 days (1 day for each test, evaluation diagnostic accuracy at end of trial)
Best fit diagnostic copeptin cut-off values for differentiation between each diagnosis (Primary polydipsia, partial and complete central Diabetes insipidus) upon arginine stimulation and hypertonic saline infusion stimulation
Time frame: 2 days (1 day for each test, evaluation diagnostic accuracy at end of trial)
Accuracy of the copeptin cut-off of 3.7 pmol/l after 60 minutes and 4.1 after 90 minutes for Arginine Stimulation test
Time frame: 2 days (1 day for each test, evaluation diagnostic accuracy at end of trial)
Sensitivity of the copeptin cut-off of 3.7 pmol/l after 60 minutes and 4.1 after 90 minutes for Arginine Stimulation test
Time frame: 2 days (1 day for each test, evaluation diagnostic accuracy at end of trial)
Specificity of the copeptin cut-off of 3.7 pmol/l after 60 minutes and 4.1 after 90 minutes for Arginine Stimulation test
Time frame: 2 days (1 day for each test, evaluation diagnostic accuracy at end of trial)
Accuracy of the copeptin cut-off of 6.5 pmol/l for Hypertonic Saline Infusion test
Time frame: 2 days (1 day for each test, evaluation diagnostic accuracy at end of trial)
Sensitivity of the copeptin cut-off of 6.5 pmol/l for Hypertonic Saline Infusion test
Time frame: 2 days (1 day for each test, evaluation diagnostic accuracy at end of trial)
Specificity of the copeptin cut-off of 6.5 pmol/l for Hypertonic Saline Infusion test
Time frame: 2 days (1 day for each test, evaluation diagnostic accuracy at end of trial)
Frequency and severity of thirst assessed by visual analogue scale during both tests
Time frame: 2 days (1 for each test)
Frequency and severity of headache assessed by visual analogue scale during both tests
Time frame: 2 days (1 for each test)
Frequency and severity of nausea assessed by visual analogue scale during both tests
Time frame: 2 days (1 for each test)
Frequency and severity of vertigo assessed by visual analogue scale during both tests
Time frame: 2 days (1 for each test)
Frequency and severity of general malaise assessed by visual analogue scale during both tests
Time frame: 2 days (1 for each test)
Subjective burden assessed by visual analogue scale of both tests
Time frame: 2 days (1 for each test)
Health care costs of both tests
Time frame: 2 days (1 for each test)
Frequency of test preference at follow up visit
Time frame: 30 days
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 27 Jul 2023.
- Derived from this study: PubMed 40294614Atila C, Chifu I, Drummond JB, Vogt DR, Nahum U, Fassnacht M, Winzeler B, Refardt J, Christ-Crain M. A novel diagnostic score for diagnosing arginine vasopressin deficiency (central diabetes insipidus) or primary polydipsia with basal laboratory and clinical parameters: results from two international multicentre prospective diagnostic studies. Lancet Diabetes Endocrinol. 2025 Jun;13(6):505-515. doi: 10.1016/S2213-8587(25)00053-1. Epub 2025 Apr 25.
- Derived from this study: PubMed 39425917Bizzozero CA, Monnerat S, Chapman FA, Dhaun N, Refardt J, Christ-Crain M. Apelin levels in patients with polyuria-polydipsia syndrome upon copeptin stimulation tests. Eur J Endocrinol. 2024 Oct 29;191(5):491-498. doi: 10.1093/ejendo/lvae138.
- Derived from this study: PubMed 37966286Refardt J, Atila C, Chifu I, Ferrante E, Erlic Z, Drummond JB, Indirli R, Drexhage RC, Sailer CO, Widmer A, Felder S, Powlson AS, Hutter N, Vogt DR, Gurnell M, Soares BS, Hofland J, Beuschlein F, Fassnacht M, Winzeler B, Christ-Crain M. Arginine or Hypertonic Saline-Stimulated Copeptin to Diagnose AVP Deficiency. N Engl J Med. 2023 Nov 16;389(20):1877-1887. doi: 10.1056/NEJMoa2306263.
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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.
Mirjam Christ-Crain, Prof, MD principal investigator
University Hospital, Basel, Switzerland
7 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arginine infusion and Hypertonic saline infusion in people with Diabetes Insipidus and Polydipsia, Primary, run by University Hospital, Basel, Switzerland at 7 sites in 6 countries.
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 3 inclusion and 11 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 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Switzerland, Brazil, Germany, Italy, Netherlands and 1 more country. 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?
The primary outcome is the overall diagnostic accuracy - defined as the proportion of correct diagnoses - of each diagnostic procedure in differentiating patients with central diabetes insipidus from patients with primary polydipsia. (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03572166, which also lists 3 linked publications.
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 27 Jul 2023.