Copeptin in the Differential Diagnosis of Dysnatremia in Hospitalized Patients (COMED)
This study is currently recruiting participants.
Verified January 2013 by University Hospital, Basel, Switzerland
Sponsor:
University Hospital, Basel, Switzerland
Collaborator:
Kantonsspital Aarau
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01456533
First received: September 30, 2011
Last updated: January 16, 2013
Last verified: January 2013
| Tracking Information | |||||||||
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| First Received Date ICMJE | September 30, 2011 | ||||||||
| Last Updated Date | January 16, 2013 | ||||||||
| Start Date ICMJE | October 2011 | ||||||||
| Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
diagnostic accuracy of copeptin within hospital stay [ Time Frame: participants will be followed for up to 1 year ] [ Designated as safety issue: No ] diagnostic accuracy will be determined by ROC (receiver operated curve) analysis. The study is powered to detect a difference of copeptin levels between patients with partial central DI (diabetes insipidus) and patients with primary polydipsia. |
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| Original Primary Outcome Measures ICMJE |
diagnostic accuracy of copeptin within hospital stay [ Time Frame: participants will be followed for the duration of hospital stay (for on average 14 days) ] [ Designated as safety issue: No ] diagnostic accuracy will be determined by ROC analysis. The study is powered to detect a difference of copeptin levels between patients with partial central DI and patients with primary polydipsia. |
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| Change History | Complete list of historical versions of study NCT01456533 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Copeptin in the Differential Diagnosis of Dysnatremia in Hospitalized Patients | ||||||||
| Official Title ICMJE | Copeptin in the Differential Diagnosis of Dysnatremia in Hospitalized Patients | ||||||||
| Brief 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. 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | hospitalized patients with severe hypo or hypernatremia |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | hospitalized patients
hospitalized patients with hyponatremia |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 300 | ||||||||
| Estimated Completion Date | October 2014 | ||||||||
| Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Switzerland | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01456533 | ||||||||
| Other Study ID Numbers ICMJE | COMED Study | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | University Hospital, Basel, Switzerland | ||||||||
| Study Sponsor ICMJE | University Hospital, Basel, Switzerland | ||||||||
| Collaborators ICMJE | Kantonsspital Aarau | ||||||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Basel, Switzerland | ||||||||
| Verification Date | January 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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