Subclassification of the Syndrome of Inappropriate ADH Se... | NCT01341665

Studies
Subclassification of the Syndrome of Inappropriate ADH Secretion

NCT01341665

Sponsor

University of Wuerzburg

Status

Completed

Last Update Posted

Apr 26, 2011Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Hyponatremia

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Apr 2011Actual

Completion Date

Apr 2011Actual

First Submitted Date

Apr 21, 2011

First Submission Date that Met QC Criteria

Apr 25, 2011

First Posted Date

Apr 26, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2011

Last Update Posted Date

Apr 26, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

patients with chronic hyponatremia (> 3 days) due to SIADH in university hospital in wuerzburg

healthy control subjects with normonatremia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bruno Allolio, MD	Ethical commitee	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Wuerzburg		Würzburg	Bavaria	97080	Germany

Condition Browse Module

MeSH Terms

ID	Term
D007010	Hyponatremia
D007177	Inappropriate ADH Syndrome
D003919	Diabetes Insipidus

Ancestor Terms

ID	Term
D014883	Water-Electrolyte Imbalance
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D010900	Pituitary Diseases

Browse Leaves

Not provided

Browse Branches

Not provided