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

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ClinicalTrials.gov Identifier: NCT01939119
Recruitment Status : Unknown
Verified September 2013 by Dr. med. Evelyn Voigt, Technische Universität Dresden.
Recruitment status was:  Recruiting
First Posted : September 11, 2013
Last Update Posted : September 11, 2013
Sponsor:
Information provided by (Responsible Party):
Dr. med. Evelyn Voigt, Technische Universität Dresden

Tracking Information
First Submitted Date September 3, 2013
First Posted Date September 11, 2013
Last Update Posted Date September 11, 2013
Study Start Date January 2013
Estimated Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 5, 2013)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: September 5, 2013)
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)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Body-fluid Balance and Drinking Habits in Patients With Retinal Vascular Occlusion
Official Title 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
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patients with retinal vascular occlusion
Condition
  • Dehydration
  • Retinal Vascular Occlusion
Intervention Not Provided
Study Groups/Cohorts retinal vascular occlusion
Patients with retinal vascular occlusion undergo a hematocrit dependent 5 day hemodilution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: September 5, 2013)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2013
Estimated Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT01939119
Other Study ID Numbers VascOcclusion/Drinking2013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr. med. Evelyn Voigt, Technische Universität Dresden
Study Sponsor Technische Universität Dresden
Collaborators Not Provided
Investigators
Study Director: Lutz E Pillunat, MD University Eye Clinic Dresden
PRS Account Technische Universität Dresden
Verification Date September 2013