DehydrationNCT01939119
Body-fluid Balance and Drinking Habits in Patients With Retinal Vascular Occlusion
An observational study of Dehydration and Retinal Vascular Occlusion, run by Technische Universität Dresden at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dehydration, Retinal Vascular Occlusion
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2013to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with retinal vascular occlusion
Who may be able to join
- informed consent
- age over 18 years
Who cannot join
- 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
Show all 9Show fewer
- end stage renal disease
- acute hepatitis, chronic inflammatory intestinal disease
- pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Eye Clinic
Dresden, Germany/ Saxony, 01307
About this study
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
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.
Read the 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.
- Conditions
- Dehydration, Retinal Vascular Occlusion
- Keywords
- retinal vascular occlusion, drinking habits, body hydration, body-fluid balance
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| retinal vascular occlusion | Patients with retinal vascular occlusion undergo a hematocrit dependent 5 day hemodilution |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in body-fluid balance
The influence of hemodilution on body-fluid balance in patients with retinal vascular occlusion is examined
Measured: 1 week
Secondary outcomes (1)
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)
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2013 (estimated)
- Study startJan 2013
- Primary completionOct 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DehydrationStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Evelyn Voigt, Technische Universität Dresden
- Investigators
- Lutz E Pillunat, MD, Study director, University Eye Clinic Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01939119
- Sponsor's protocol ID
- VascOcclusion/Drinking2013
- Status last verified
- Sep 2013
- First submitted
- 3 Sep 2013
- Last updated
- 11 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01939119
- Acronym / sponsor ID
- VascOcclusion/Drinking2013
- Conditions
- Dehydration, Retinal Vascular Occlusion
- Keywords
- retinal vascular occlusion, drinking habits, body hydration, body-fluid balance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 11 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| retinal vascular occlusion | – | –Patients with retinal vascular occlusion undergo a hematocrit dependent 5 day hemodilution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with retinal vascular occlusion
Key inclusion criteria (2 listed)
- informed consent
- age over 18 years
Key exclusion criteria (9 listed)
- age under 18 years
- hypertensive urgency
- myocardial infarction < 4 weeks ago, chest pain
- heart rhythm disorders, high degree valvular defects
- pacemaker, defibrillator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 secondary outcome
number of participants with dehydration
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lutz E Pillunat, MD study director
University Eye Clinic Dresden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dehydration and Retinal Vascular Occlusion, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Evelyn Voigt, MD (00493514583381, evelyn.voigt@uniklinikum-dresden.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in body-fluid balance (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2013.