Renal Failure, ChronicPhase 4NCT00438295
Temperature Control During Dialysis Treatment
A Phase 4 study of Renal Failure, Chronic, run by Regional Hospital Holstebro at 1 site in Denmark.
Trial summary
The purpose is to measure the effect of glucose in the dialysis water on blood pressure, pulse rate, and plasma glucose with and without body temperature control Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure, Chronic
- Type of treatment
- Surgery or procedure
- How many people
- 18 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2006to May 2007
- Phase
- Phase 4
- 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
Who may be able to join
- Age > 18 years,
- both men and women,
- chronic renal failure and dialysis treatment for at least three months
Who cannot join
- Heart failure,
- Lung insufficiency,
- Chronic liver disease,
- Diabetes mellitus,
- Malignant disease,
- Nephrotic syndrome,
- Lack of compliance,
- Unwillingness til participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Temperature Control During Dialysis Treatment With Glucose in Dialysis Water in Patients With Chronic Renal Failure
The purpose is to measure the effect of glucose in the dialysis water on blood pressure, pulse rate, and plasma glucose with and without body temperature control
Read the detailed description
To clarify the influence of temperature in dialysis water on blood pressure and vasoactive hormones
- Conditions
- Renal Failure, Chronic
- Being tested
- temperature control
- Keywords
- glucose in dialysis water, dialysis treatment, temperature
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
temperature controlProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of temperature control on blood pressure, pulse rate and blod glucose during dialysis treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2007 (estimated)
- Study startAug 2006
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Failure, ChronicStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regional Hospital Holstebro
- Sponsor type
- University, hospital or other
- Investigators
- Erling B Pedersen, Professor, Study chair, Regional Hospital Holstebro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00438295
- Sponsor's protocol ID
- MED.RES.2007.03.EBP
- Status last verified
- Sep 2007
- First submitted
- 20 Feb 2007
- Last updated
- 15 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Temperature Control During Dialysis Treatment With Glucose in Dialysis Water in Patients With Chronic Renal Failure
- ClinicalTrials.gov ID
- NCT00438295
- Acronym / sponsor ID
- MED.RES.2007.03.EBP
- Conditions
- Renal Failure, Chronic
- Keywords
- glucose in dialysis water, dialysis treatment, temperature
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Regional Hospital HolstebroUniversity, hospital or other
- Study start
- Aug 2006
- Study completion
- May 2007 (actual)
- First posted
- 22 Feb 2007 (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 is to measure the effect of glucose in the dialysis water on blood pressure, pulse rate, and plasma glucose with and without body temperature control
Detailed description
To clarify the influence of temperature in dialysis water on blood pressure and vasoactive hormones
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years,
- both men and women,
- chronic renal failure and dialysis treatment for at least three months
Key exclusion criteria (8 listed)
- Heart failure,
- Lung insufficiency,
- Chronic liver disease,
- Diabetes mellitus,
- Malignant disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| temperature control | Procedure or surgery | – |
Primary outcome
Effect of temperature control on blood pressure, pulse rate and blod glucose during dialysis treatment
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 15 Sep 2015.
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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.
Erling B Pedersen, Professor study chair
Regional Hospital Holstebro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Renal Failure, Chronic, run by Regional Hospital Holstebro 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 3 inclusion and 8 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 15 Sep 2015. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Effect of temperature control on blood pressure, pulse rate and blod glucose during dialysis treatment. 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 15 Sep 2015.