NCT01939119

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 11, 2013

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

September 11, 2013

Status Verified

September 1, 2013

Enrollment Period

9 months

First QC Date

September 3, 2013

Last Update Submit

September 5, 2013

Conditions

DehydrationRetinal Vascular Occlusion

Keywords

retinal vascular occlusiondrinking habitsbody hydrationbody-fluid balance

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • number of participants with dehydration

    1 week

Study Arms (1)

retinal vascular occlusion

Patients with retinal vascular occlusion undergo a hematocrit dependent 5 day hemodilution

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with retinal vascular occlusion

You may qualify if:

  • informed consent
  • age over 18 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Eye Clinic

Dresden, Germany/ Saxony, 01307, Germany

RECRUITING

MeSH Terms

Conditions

Dehydration

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lutz E Pillunat, MD

    University Eye Clinic Dresden

    STUDY DIRECTOR

Central Study Contacts

Evelyn Voigt, MD

CONTACT

00493514583381evelyn.voigt@uniklinikum-dresden.de

Karin Pillunat, MD

CONTACT

00493514583274karin.pillunat@uniklinikum-dresden.de

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med.

Study Record Dates

First Submitted

September 3, 2013

First Posted

September 11, 2013

Study Start

January 1, 2013

Primary Completion

October 1, 2013

Study Completion

December 1, 2013

Last Updated

September 11, 2013

Record last verified: 2013-09

Locations

DE(1)