Copeptin Blood ValuesNCT02647736
Copeptin in Normal- to Hyperosmolar States
A study testing Hypertonic saline infusion in people with Copeptin Blood Values, run by University Hospital, Basel, Switzerland at 2 sites in 2 countries.
Trial summary
Kinetics of Copeptin in response to osmotic alterations in healthy volunteers Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Copeptin Blood Values
- What is being tested?
- Hypertonic saline infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2012to Jul 2016
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Minimum Age 18
- no severe comorbidities
- no medication (except contraceptives)
- baseline sodium Level 135-145mmol/l
- euvolemic status
Who cannot join
- history of heart failure
- liver cirrhosis
- kidney disease (GFR <60ml/min)
- anemia
- uncontrolled Hypertension
- pregnancy
Show all 9Show fewer
- Diabetes mellitus
- BMI >28kg/m2
- other severe disease
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Kinetics of Copeptin in Healthy Volunteers - a Prospective International Study
Kinetics of Copeptin in response to osmotic alterations in healthy volunteers
Read the detailed description
Construction of the standard area of copeptin release in the normo- and hyperosmolar state and its half-life based on ist decline during hypoosmotic Suppression in healthy volunteers.
- Conditions
- Copeptin Blood Values
- Being tested
- Hypertonic saline infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypertonic saline infusionOther
| Study group | Role | What they receive |
|---|---|---|
| Copeptin values in normo- to hyperosmolar states | Experimental | Not described Receives: Other: Hypertonic saline infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiological relationship between Serum osmolality and Plasma copeptin release.
Copeptin and Blood osmolality will be measured concomitantly while hypertonic saline is infused. The infusion is continued until a hyperosmolar state is reached (defined with a sodium-level of 150mmol/l).
Definition of an area of normality describing the physiological relationship between Serum osmolality and Plasma copeptin release in normo- to hyperosmolar states.
Measured: beginning and end of protocol, up to 8 hours
Half life of Copeptin
Calculation of Copeptin half-life based on its decline during hypoosmotic suppression (oral waterload and glucose 5%-infusion)
Measured: beginning and end of protocol, up to 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startSep 2012
- Primary completionJul 2016
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 Copeptin Blood ValuesStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mirjam Christ-Crain, University Hospital, Basel, Switzerland
- Investigators
- Mirjam Christ-Crain, Prof., Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02647736
- Sponsor's protocol ID
- CoNorm
- Status last verified
- Aug 2016
- First submitted
- 23 Dec 2015
- Last updated
- 3 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sailer CO, Refardt J, Blum CA, Schnyder I, Molina-Tijeras JA, Fenske W, Christ-Crain M. Validity of different copeptin assays in the differential diagnosis of the polyuria-polydipsia syndrome. Sci Rep. 2021 May 12;11(1):10104. doi: 10.1038/s41598-021-89505-9.
PubMed 33980941Fenske WK, Schnyder I, Koch G, Walti C, Pfister M, Kopp P, Fassnacht M, Strauss K, Christ-Crain M. Release and Decay Kinetics of Copeptin vs AVP in Response to Osmotic Alterations in Healthy Volunteers. J Clin Endocrinol Metab. 2018 Feb 1;103(2):505-513. doi: 10.1210/jc.2017-01891.
PubMed 29267966
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinetics of Copeptin in Healthy Volunteers - a Prospective International Study
- ClinicalTrials.gov ID
- NCT02647736
- Acronym / sponsor ID
- CoNorm
- Conditions
- Copeptin Blood Values
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jul 2016 (actual)
- First posted
- 6 Jan 2016 (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.
Kinetics of Copeptin in response to osmotic alterations in healthy volunteers
Detailed description
Construction of the standard area of copeptin release in the normo- and hyperosmolar state and its half-life based on ist decline during hypoosmotic Suppression in healthy volunteers.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Copeptin values in normo- to hyperosmolar states | Experimental | Other: Hypertonic saline infusion |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Minimum Age 18
- no severe comorbidities
- no medication (except contraceptives)
- baseline sodium Level 135-145mmol/l
- euvolemic status
Key exclusion criteria (9 listed)
- history of heart failure
- liver cirrhosis
- kidney disease (GFR <60ml/min)
- anemia
- uncontrolled Hypertension
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 |
|---|---|---|
| Hypertonic saline infusion | Other | Copeptin values in normo- to hyperosmolar states |
Primary outcome
Physiological relationship between Serum osmolality and Plasma copeptin release.
Time frame: beginning and end of protocol, up to 8 hours
Copeptin and Blood osmolality will be measured concomitantly while hypertonic saline is infused. The infusion is continued until a hyperosmolar state is reached (defined with a sodium-level of 150mmol/l). Definition of an area of normality describing the physiological relationship between Serum osmolality and Plasma copeptin release in normo- to hyperosmolar states.
Half life of Copeptin
Time frame: beginning and end of protocol, up to 8 hours
Calculation of Copeptin half-life based on its decline during hypoosmotic suppression (oral waterload and glucose 5%-infusion)
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 3 Aug 2016.
- Derived from this study: PubMed 33980941Sailer CO, Refardt J, Blum CA, Schnyder I, Molina-Tijeras JA, Fenske W, Christ-Crain M. Validity of different copeptin assays in the differential diagnosis of the polyuria-polydipsia syndrome. Sci Rep. 2021 May 12;11(1):10104. doi: 10.1038/s41598-021-89505-9.
- Derived from this study: PubMed 29267966Fenske WK, Schnyder I, Koch G, Walti C, Pfister M, Kopp P, Fassnacht M, Strauss K, Christ-Crain M. Release and Decay Kinetics of Copeptin vs AVP in Response to Osmotic Alterations in Healthy Volunteers. J Clin Endocrinol Metab. 2018 Feb 1;103(2):505-513. doi: 10.1210/jc.2017-01891.
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. principal investigator
University Hospital, Basel, Switzerland
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypertonic saline infusion in people with Copeptin Blood Values, run by University Hospital, Basel, Switzerland at 2 sites in 2 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 5 inclusion and 9 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 3 Aug 2016. 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 Germany, 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?
Physiological relationship between Serum osmolality and Plasma copeptin release. (time frame: beginning and end of protocol, up to 8 hours). The study lists 2 primary outcomes in all. 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 NCT02647736, 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 3 Aug 2016.