HypoosmolalityNCT00696605
Assessment of Circulating Copeptin Levels in Healthy Subjects and Patients With Renal Insufficiency After Oral Water Load and Hypertonic Saline Infusion
An observational study of Hypoosmolality and Hyperosmolality, run by Hospital Centre Biel/Bienne at 1 site in Switzerland.
Trial summary
The are 2 principal goals in this study: 1. To measure plasma copeptin levels in healthy subjects and to correlate them with plasma AVP concentrations and urine osmolalities in iso-, hypo-, and hyperosmolar states. 2. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoosmolality, Hyperosmolality, Renal Failure
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2008to Oct 2009
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers; patients with chronic renal failure
Who may be able to join
- chronic renal failure grade I through IV
- healthy age-matched controls
Who cannot join
- chronic renal failure grade V
- heart failure
- liver disease
- nephrotic syndrome
- anemia (hemoglobin level < 100 g/L)
- uncontrolled hypertension (systolic BP > 160 mmHg; diastolic BP > 95 mm Hg)
Show all 13Show fewer
- coexisting severe disease
- known thyroid disease
- known hypocortisolism
- known hypercortisolism
- known diabetes insipidus
- pregnancy
- lactation
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Clinic of Internal Medicine, Hospital Center
Biel/Bienne, 2501
About this study
The are 2 principal goals in this study:
- To measure plasma copeptin levels in healthy subjects and to correlate them with plasma AVP concentrations and urine osmolalities in iso-, hypo-, and hyperosmolar states.
- To measure plasma copeptin concentrations in patients with chronic renal failure under the same conditions described above, in order to characterize the impact of renal function on circulating copeptin levels in correlation to plasma AVP and urine osmolality.
- Conditions
- Hypoosmolality, Hyperosmolality, Renal Failure
- Keywords
- Hypoosmolality, Hyperosmolality, Copeptin, Vasopressin
- Medical subject headings
- Renal Insufficiency, Diabetes Insipidus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2008 (estimated)
- Study startJul 2008
- Primary completionJan 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypoosmolalityStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Centre Biel/Bienne
- Sponsor type
- University, hospital or other
- Collaborators
- Brahms AG
- Responsible party
- Principal investigator, Jonas Rutishauser, Hospital Centre Biel/Bienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00696605
- Sponsor's protocol ID
- Swiss AVP-Copeptin Trial
- Status last verified
- Feb 2017
- First submitted
- 10 Jun 2008
- Last updated
- 27 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Balanescu S, Kopp P, Gaskill MB, Morgenthaler NG, Schindler C, Rutishauser J. Correlation of plasma copeptin and vasopressin concentrations in hypo-, iso-, and hyperosmolar States. J Clin Endocrinol Metab. 2011 Apr;96(4):1046-52. doi: 10.1210/jc.2010-2499. Epub 2011 Feb 2.
PubMed 21289257
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Circulating Copeptin Levels in Healthy Subjects and Patients With Renal Insufficiency After Oral Water Load and Hypertonic Saline Infusion
- ClinicalTrials.gov ID
- NCT00696605
- Acronym / sponsor ID
- Swiss AVP-Copeptin Trial
- Conditions
- Hypoosmolality, Hyperosmolality, Renal Failure
- Keywords
- Hypoosmolality, Hyperosmolality, Copeptin, Vasopressin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospital Centre Biel/BienneUniversity, hospital or other
- Collaborators
- Brahms AG
- Study start
- Jul 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 12 Jun 2008 (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.
The are 2 principal goals in this study:
- To measure plasma copeptin levels in healthy subjects and to correlate them with plasma AVP concentrations and urine osmolalities in iso-, hypo-, and hyperosmolar states.
- To measure plasma copeptin concentrations in patients with chronic renal failure under the same conditions described above, in order to characterize the impact of renal function on circulating copeptin levels in correlation to plasma AVP and urine osmolality.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers; patients with chronic renal failure
Key inclusion criteria (2 listed)
- chronic renal failure grade I through IV
- healthy age-matched controls
Key exclusion criteria (13 listed)
- chronic renal failure grade V
- heart failure
- liver disease
- nephrotic syndrome
- anemia (hemoglobin level < 100 g/L)
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
Not reported in the source record.
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 Feb 2017.
- Derived from this study: PubMed 21289257Balanescu S, Kopp P, Gaskill MB, Morgenthaler NG, Schindler C, Rutishauser J. Correlation of plasma copeptin and vasopressin concentrations in hypo-, iso-, and hyperosmolar States. J Clin Endocrinol Metab. 2011 Apr;96(4):1046-52. doi: 10.1210/jc.2010-2499. Epub 2011 Feb 2.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hypoosmolality and Hyperosmolality, run by Hospital Centre Biel/Bienne at 1 site 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 2 inclusion and 13 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 Feb 2017. 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 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00696605, which also lists 1 linked publication.
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 Feb 2017.