NCT01341665

Brief Summary

The aim of this study is to evaluate the different types of osmotic dysregulation in patients with Syndrome of Inappropriate ADH (SIADH) and, hence, to analyze the pathophysiology of SIADH. These types will be characterized by measurement of AVP and copeptin while performing an osmotic stimulation with infusion of hypertonic saline.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 26, 2011

Completed
Last Updated

April 26, 2011

Status Verified

April 1, 2011

Enrollment Period

3.1 years

First QC Date

April 21, 2011

Last Update Submit

April 25, 2011

Conditions

Hyponatremia

Keywords

hyponatremiaSIADHcopeptin

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with chronic hyponatremia (\> 3 days) due to SIADH in university hospital in wuerzburg healthy control subjects with normonatremia

You may qualify if:

  • age \> 18 years,
  • hyponatremia \< 132 mmol/L
  • SIADH

You may not qualify if:

  • age \< 18 years
  • cerebral metastases
  • serum sodium \> 132mmol/L

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wuerzburg

Würzburg, Bavaria, 97080, Germany

Location

MeSH Terms

Conditions

HyponatremiaInappropriate ADH SyndromeDiabetes Insipidus

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Bruno Allolio, MD

    Ethical commitee

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 21, 2011

First Posted

April 26, 2011

Study Start

March 1, 2008

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

April 26, 2011

Record last verified: 2011-04

Locations

DE(1)