HyponatremiaCOMEDNCT01456533
Copeptin in the Differential Diagnosis of Dysnatremia in Hospitalized Patients
An observational study of Hyponatremia and Hypernatremia, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
Trial summary
Background: Hypo- and hypernatremia are common in hospitalized patients. The differential diagnosis of dysnatremia is challenging. Osmotically inadequate secretion of antidiuretic hormone (ADH) is the predominant mechanism in most dysnatremic disorders. ADH measurement is cumbersome. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Hyponatremia, Hypernatremia
- How many people
- 300 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Oct 2011to Apr 2015
- 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 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: hospitalized patients with severe hypo or hypernatremia
Who may be able to join
- hyponatremia <125 or hypernatremia >155 mmol/L
Who cannot join
- no informed consent
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Beat Müller
Aarau, Canton of Aargau
Mirjam Christ-Crain
Basel, Basel, 4031
About this study
Background: Hypo- and hypernatremia are common in hospitalized patients. The differential diagnosis of dysnatremia is challenging.
Osmotically inadequate secretion of antidiuretic hormone (ADH) is the predominant mechanism in most dysnatremic disorders. ADH measurement is cumbersome. It is derived from a larger precursor peptide along with copeptin, which is a more stable peptide directly mirroring the production of ADH.
Objective: To evaluate the additional value of copeptin to improve a currently used algorithm in the differential diagnosis of (A) severe hypoosmolar hypo- and (B) severe hypernatremia.
Design: Prospective observational study.
- Conditions
- Hyponatremia, Hypernatremia
- Keywords
- hyponatremia, hypernatremia
- Medical subject headings
- Hyponatremia, Hypernatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| hospitalized patients | hospitalized patients with hyponatremia |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic accuracy of copeptin within hospital stay
diagnostic accuracy will be determined by receiver operated curve (ROC) analysis. The study is powered to detect a difference of copeptin levels between patients with partial central diabetes insipidus (DI) and patients with primary polydipsia.
Measured: participants will be followed for up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HyponatremiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Kantonsspital Aarau
- Responsible party
- Sponsor
- Investigators
- Mirjam Christ-Crain, MD, PhD, Principal investigator, University Hospital, Basel, SwitzerlandBeat Müller, MD, Principal investigator, Kantonsspital Aarau, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01456533
- Sponsor's protocol ID
- COMED Study
- Acronym
- COMED
- Status last verified
- Nov 2015
- First submitted
- 30 Sep 2011
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Sailer CO, Winzeler B, Nigro N, Bernasconi L, Mueller B, Christ-Crain M. Influence of Outdoor Temperature and Relative Humidity on Incidence and Etiology of Hyponatremia. J Clin Endocrinol Metab. 2019 Apr 1;104(4):1304-1312. doi: 10.1210/jc.2018-01507.
PubMed 30462243Nigro N, Winzeler B, Suter-Widmer I, Schuetz P, Arici B, Bally M, Refardt J, Betz M, Gashi G, Urwyler SA, Burget L, Blum CA, Bock A, Huber A, Muller B, Christ-Crain M. Copeptin levels and commonly used laboratory parameters in hospitalised patients with severe hypernatraemia - the "Co-MED study". Crit Care. 2018 Feb 9;22(1):33. doi: 10.1186/s13054-018-1955-7.
PubMed 29422070
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Copeptin in the Differential Diagnosis of Dysnatremia in Hospitalized Patients
- ClinicalTrials.gov ID
- NCT01456533
- Acronym / sponsor ID
- COMED / COMED Study
- Conditions
- Hyponatremia, Hypernatremia
- Keywords
- hyponatremia, hypernatremia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Kantonsspital Aarau
- Study start
- Oct 2011
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 20 Oct 2011 (estimated)
- 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.
Background: Hypo- and hypernatremia are common in hospitalized patients. The differential diagnosis of dysnatremia is challenging.
Osmotically inadequate secretion of antidiuretic hormone (ADH) is the predominant mechanism in most dysnatremic disorders. ADH measurement is cumbersome. It is derived from a larger precursor peptide along with copeptin, which is a more stable peptide directly mirroring the production of ADH.
Objective: To evaluate the additional value of copeptin to improve a currently used algorithm in the differential diagnosis of (A) severe hypoosmolar hypo- and (B) severe hypernatremia.
Design: Prospective observational study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hospitalized patients | – | –hospitalized patients with hyponatremia |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- hospitalized patients with severe hypo or hypernatremia
Key inclusion criteria (1 listed)
- hyponatremia <125 or hypernatremia >155 mmol/L
Key exclusion criteria (1 listed)
- no informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
diagnostic accuracy of copeptin within hospital stay
Time frame: participants will be followed for up to 1 year
diagnostic accuracy will be determined by receiver operated curve (ROC) analysis. The study is powered to detect a difference of copeptin levels between patients with partial central diabetes insipidus (DI) and patients with primary polydipsia.
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 2 Dec 2015.
- Derived from this study: PubMed 30462243Sailer CO, Winzeler B, Nigro N, Bernasconi L, Mueller B, Christ-Crain M. Influence of Outdoor Temperature and Relative Humidity on Incidence and Etiology of Hyponatremia. J Clin Endocrinol Metab. 2019 Apr 1;104(4):1304-1312. doi: 10.1210/jc.2018-01507.
- Derived from this study: PubMed 29422070Nigro N, Winzeler B, Suter-Widmer I, Schuetz P, Arici B, Bally M, Refardt J, Betz M, Gashi G, Urwyler SA, Burget L, Blum CA, Bock A, Huber A, Muller B, Christ-Crain M. Copeptin levels and commonly used laboratory parameters in hospitalised patients with severe hypernatraemia - the "Co-MED study". Crit Care. 2018 Feb 9;22(1):33. doi: 10.1186/s13054-018-1955-7.
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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, MD, PhD principal investigator
University Hospital, Basel, Switzerland
Beat Müller, MD principal investigator
Kantonsspital Aarau, University Hospital Basel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyponatremia and Hypernatremia, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
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 1 inclusion and 1 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 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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?
diagnostic accuracy of copeptin within hospital stay (time frame: participants will be followed for up to 1 year). 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 NCT01456533, which also lists 2 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 2 Dec 2015.