The Clinical and Laboratory Characteristics of Recurrent... | NCT01509170

Studies
The Clinical and Laboratory Characteristics of Recurrent Drug- Related Hyponatremia

NCT01509170

Sponsor

Hadassah Medical Organization

Status

Unknown status

Last Update Posted

Jan 12, 2012Estimated

Enrollment

500Estimated

Phase

Not provided

Conditions

Hyponatremia
SIADH

Interventions

Not provided

Countries

Israel

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

ID	Type	Description	Link
0597	Other Identifier	HMO

Status Module

Record Verification Date

Jan 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012

Primary Completion Date

Jan 2015Estimated

Completion Date

Jan 2017Estimated

First Submitted Date

Jan 10, 2012

First Submission Date that Met QC Criteria

Jan 10, 2012

First Posted Date

Jan 12, 2012Estimated

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

Jan 10, 2012

Last Update Posted Date

Jan 12, 2012Estimated

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 identify factors associated with hyponatremia among patients hospitalized in the internal medicine ward. Consequtive patients hospitalized because of hyponatremia will be recruited. Follow up will include clinical factors such as background diseases, complete drug history, blood tests including Biochemistry tests (Sodium, renal function), endocrinological evaluation, thyroid function tests, cortisol,urinary sodium on addmition. One month following discharge follow up Sodium level will be taken.

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

500Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients hospitalized to the internal medicine ward due to hyponatremia

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Consequtive patients hospitalized to the internal medicine ward due to hyponatremia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mordechai Muszkat, MD	Hadassah Medical Organization	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah- Hebrew-University Medical Center		Jerusalem		91120	Israel

Condition Browse Module

MeSH Terms

ID	Term
D007010	Hyponatremia
D007177	Inappropriate ADH Syndrome

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