Body-fluid Balance and Drinking Habits in Patients With R... | NCT01939119

Studies
Body-fluid Balance and Drinking Habits in Patients With Retinal Vascular Occlusion

NCT01939119

Sponsor

Technische Universität Dresden

Status

Unknown status

Last Update Posted

Sep 11, 2013Estimated

Enrollment

30Estimated

Phase

Not provided

Conditions

Dehydration
Retinal Vascular Occlusion

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

Sep 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Oct 2013Estimated

Completion Date

Dec 2013Estimated

First Submitted Date

Sep 3, 2013

First Submission Date that Met QC Criteria

Sep 5, 2013

First Posted Date

Sep 11, 2013Estimated

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

Sep 5, 2013

Last Update Posted Date

Sep 11, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. med. Evelyn Voigt, Dr. med., Technische Universität DresdenPrincipal Investigator

Lead Sponsor

Technische Universität DresdenOTHER

Collaborators

Not provided

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 purpose of this study is to examine the body-fluid balance in patients with retinal vascular occlusion and the influence of drinking habits and hemodilution on the degree of body hydration.

Detailed Description

Patients with retinal vascular occlusion who are hospitalized for hemodilution and cardiovascular risk assessment are asked to report their drinking habits. Hydration status before and during hemodilution is assessed with a body-fluid analyzing scale.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
retinal vascular occlusion		Patients with retinal vascular occlusion undergo a hematocrit dependent 5 day hemodilution

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
changes in body-fluid balance	The influence of hemodilution on body-fluid balance in patients with retinal vascular occlusion is examined	1 week

Secondary Outcomes

Measure	Description	Time Frame
number of participants with dehydration	All patients are asked to fill in a questionnaire concerning their drinking habits (thirst, fluid intake). Patients body-fluid balance during hemodilution is measured with bioimpedance spectroscopy (Body Composition Monitor, Fresenius)	1 week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

informed consent
age over 18 years

Exclusion Criteria:

age under 18 years
hypertensive urgency
myocardial infarction < 4 weeks ago, chest pain
heart rhythm disorders, high degree valvular defects
pacemaker, defibrillator
peripheral arterial occlusive disease
end stage renal disease
acute hepatitis, chronic inflammatory intestinal disease
pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients with retinal vascular occlusion

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Evelyn Voigt, MD	Contact	00493514583381		evelyn.voigt@uniklinikum-dresden.de
Karin Pillunat, MD	Contact	00493514583274		karin.pillunat@uniklinikum-dresden.de

Overall Officials

Name	Affiliation	Role
Lutz E Pillunat, MD	University Eye Clinic Dresden	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Eye Clinic	Recruiting	Dresden	Germany/ Saxony	01307	Germany

Condition Browse Module

MeSH Terms

ID	Term
D003681	Dehydration

Ancestor Terms

ID	Term
D014883	Water-Electrolyte Imbalance
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided