Intradialytic HypotensionNCT00257504
Central Blood Volume in Hypotensive Dialysis Patients
An observational study of Intradialytic Hypotension, run by Danish State Hospital at 1 site in Denmark.
Trial summary
The purpose of the study is to test whether hypotensive episodes during dialysis - caused by withdrawal of fluid drom the circulation - can be predicted by means of two harmless monitoring techniques. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intradialytic Hypotension
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2005to May 2006
- 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
- Adult, Older adult
Who may be able to join
- Chronic hemodialysis patients with central vascular access
Who cannot join
- Patients below 18 years of age
- Patients unable to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Registration of Central Blood Volume in Hypotensive Dialysis Patients - a Comparison of Thoracic Impedance and Central Venous Saturation Monitoring
The purpose of the study is to test whether hypotensive episodes during dialysis - caused by withdrawal of fluid drom the circulation - can be predicted by means of two harmless monitoring techniques.
- Conditions
- Intradialytic Hypotension
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2005 (estimated)
- Study startNov 2005
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intradialytic HypotensionStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Other
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Danish State Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Søren D Ladefoged, MD, Study director, Danish State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00257504
- Sponsor's protocol ID
- CBV estimation
- Status last verified
- Sep 2006
- First submitted
- 21 Nov 2005
- Last updated
- 12 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registration of Central Blood Volume in Hypotensive Dialysis Patients - a Comparison of Thoracic Impedance and Central Venous Saturation Monitoring
- ClinicalTrials.gov ID
- NCT00257504
- Acronym / sponsor ID
- CBV estimation
- Conditions
- Intradialytic Hypotension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Danish State HospitalUniversity, hospital or other
- Study start
- Nov 2005
- Study completion
- May 2006
- First posted
- 23 Nov 2005 (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 the study is to test whether hypotensive episodes during dialysis - caused by withdrawal of fluid drom the circulation - can be predicted by means of two harmless monitoring techniques.
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic hemodialysis patients with central vascular access
Key exclusion criteria (2 listed)
- Patients below 18 years of age
- Patients unable to give informed consent
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2006.
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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.
Søren D Ladefoged, MD study director
Danish State Hospital
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 Intradialytic Hypotension, run by Danish State Hospital at 1 site in Denmark.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 12 Sep 2006. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 12 Sep 2006.