- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01939119
Body-fluid Balance and Drinking Habits in Patients With Retinal Vascular Occlusion
September 5, 2013 updated by: Dr. med. Evelyn Voigt, Technische Universität Dresden
Examination of the Body-fluid Balance in Patients With Retinal Vascular Occlusion Before and During Hemodilution and the Influence of Drinking Habits on the Degree of Body Hydration
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.
Study Overview
Status
Unknown
Conditions
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.
Study Type
Observational
Enrollment (Anticipated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Evelyn Voigt, MD
- Phone Number: 00493514583381
- Email: evelyn.voigt@uniklinikum-dresden.de
Study Contact Backup
- Name: Karin Pillunat, MD
- Phone Number: 00493514583274
- Email: karin.pillunat@uniklinikum-dresden.de
Study Locations
-
-
Germany/ Saxony
-
Dresden, Germany/ Saxony, Germany, 01307
- Recruiting
- University Eye Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients with retinal vascular occlusion
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
retinal vascular occlusion
Patients with retinal vascular occlusion undergo a hematocrit dependent 5 day hemodilution
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes in body-fluid balance
Time Frame: 1 week
|
The influence of hemodilution on body-fluid balance in patients with retinal vascular occlusion is examined
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of participants with dehydration
Time Frame: 1 week
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Lutz E Pillunat, MD, University Eye Clinic Dresden
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Anticipated)
October 1, 2013
Study Completion (Anticipated)
December 1, 2013
Study Registration Dates
First Submitted
September 3, 2013
First Submitted That Met QC Criteria
September 5, 2013
First Posted (Estimate)
September 11, 2013
Study Record Updates
Last Update Posted (Estimate)
September 11, 2013
Last Update Submitted That Met QC Criteria
September 5, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VascOcclusion/Drinking2013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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