End Stage Renal DiseaseDIALBPNCT03318653
Blood Pressure Measurement in Dialysed Patients
An observational study of End Stage Renal Disease, run by PD Dr. Grégoire Wuerzner at 1 site in Switzerland.
Trial summary
The objective of the current study is to evaluate the compliance to blood pressure measurements' recommendations in dialysis centers. The idea is to address a questionnaire to physicians, head nurses and patients in order to probe the way to measure blood pressure. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- End Stage Renal Disease
- How many people
- 192 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Jun 2017to 15 Mar 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients from dialysis centers
Who may be able to join
- Dialysed patients (hemodialysis or peritoneal dialysis)
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1011
About this study
Official title: Adherence to Blood Pressure Measurement Guidelines for Patients With End-stage Renal Disease on Renal Replacement Therapy (hæmodialysis or Peritoneal Dialysis)
The objective of the current study is to evaluate the compliance to blood pressure measurements' recommendations in dialysis centers.
The idea is to address a questionnaire to physicians, head nurses and patients in order to probe the way to measure blood pressure. The objective is to face the theoretical guideline with what is effectively done.
Read the detailed description
In dialysis center, blood pressure is measured as well as a vital sign than as a predictor of cardiovascular event. Accurate measurement of blood pressure is critical for making appropriate clinical decisions. Guidelines have been issued on standard blood pressure measurement procedure for the detection of hypertension and the follow-up of patients with hypertension. In hospital adherence to guidelines is low (Manzoli, Simonetti et al. 2012). Whether these guidelines are followed in dialysis patients is not known. Thus it would be of great interest to investigate the BP measurement procedures that are effectively applied in dialysis centers.
This project is an international survey across 10 dialysis centers. The current study is conducted on 10 physicians, 10 head nurses and 100 to 200 patients in Switzerland, in Europe and in the Mediterranean basin.
The adherence to BP measurement guidelines will be assessed thanks to two questionnaires of 20 items; one addressed to the patients and the other to the medical staff (clinicians and head nurses).
The project is scheduled to last a total of 4 months. Two months are dedicated to the presentation of the project, the recruitment as well as to the participation of the volunteers, and two months to the analysis.
The research project is carried out in accordance to the research plan and with principles enunciated in the current version of the Declaration of Helsinki (DoH), the Essentials of Good Epidemiological Practice issued by Public Health Schweiz (EGEP), the Swiss Law and Swiss regulatory authority's requirements as applicable.
- Conditions
- End Stage Renal Disease
- Keywords
- Blood pressure, Dialysis
- 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.
| Study group | Role | What they receive |
|---|---|---|
| HD - Hemodialysis | Patients with end stage renal disease treated with hemodialysis | |
| PD - Peritoneal dialysis | Patients with end stage renal disease treated with peritoneal dialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality score
To assess adherence to blood pressure measurement guidelines, a quality score is obtained from the surveys by assigning 1 point for each correct answer and 0 for the other one. The "perfect" and maximum score is 21. Higher scores indicate a better adherence to guidelines.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start20 Jun 2017
- Primary completion15 Mar 2018
- Study completion15 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PD Dr. Grégoire Wuerzner
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva, Universitair Ziekenhuis Brussel, Cliniques universitaires Saint-Luc- Université Catholique de Louvain, Royal Infirmary of Edinburgh, Central Hospital, Nancy, France
- Responsible party
- Sponsor-investigator, PD Dr. Grégoire Wuerzner, Centre Hospitalier Universitaire Vaudois
- Investigators
- Grégoire Wuerzner, MD, Principal investigator, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03318653
- Sponsor's protocol ID
- 2017-00352
- Other IDs
- 2017
- Acronym
- DIALBP
- Status last verified
- Mar 2018
- First submitted
- 19 Oct 2017
- Last updated
- 16 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: it is planne to put IPD on zenodo Platform 1 year after publication
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to Blood Pressure Measurement Guidelines for Patients With End-stage Renal Disease on Renal Replacement Therapy (hæmodialysis or Peritoneal Dialysis)
- ClinicalTrials.gov ID
- NCT03318653
- Acronym / sponsor ID
- DIALBP / 2017-00352
- Conditions
- End Stage Renal Disease
- Keywords
- Blood pressure, Dialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- PD Dr. Grégoire WuerznerUniversity, hospital or other
- Collaborators
- University Hospital, Geneva, Universitair Ziekenhuis Brussel, Cliniques universitaires Saint-Luc- Université Catholique de Louvain, Royal Infirmary of Edinburgh, Central Hospital, Nancy, France
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 15 Mar 2018 (actual)
- Study completion
- 15 Mar 2018 (actual)
- First posted
- 24 Oct 2017 (actual)
- 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 objective of the current study is to evaluate the compliance to blood pressure measurements' recommendations in dialysis centers.
The idea is to address a questionnaire to physicians, head nurses and patients in order to probe the way to measure blood pressure. The objective is to face the theoretical guideline with what is effectively done.
Detailed description
In dialysis center, blood pressure is measured as well as a vital sign than as a predictor of cardiovascular event. Accurate measurement of blood pressure is critical for making appropriate clinical decisions. Guidelines have been issued on standard blood pressure measurement procedure for the detection of hypertension and the follow-up of patients with hypertension. In hospital adherence to guidelines is low (Manzoli, Simonetti et al. 2012). Whether these guidelines are followed in dialysis patients is not known. Thus it would be of great interest to investigate the BP measurement procedures that are effectively applied in dialysis centers.
This project is an international survey across 10 dialysis centers. The current study is conducted on 10 physicians, 10 head nurses and 100 to 200 patients in Switzerland, in Europe and in the Mediterranean basin.
The adherence to BP measurement guidelines will be assessed thanks to two questionnaires of 20 items; one addressed to the patients and the other to the medical staff (clinicians and head nurses).
The project is scheduled to last a total of 4 months. Two months are dedicated to the presentation of the project, the recruitment as well as to the participation of the volunteers, and two months to the analysis.
The research project is carried out in accordance to the research plan and with principles enunciated in the current version of the Declaration of Helsinki (DoH), the Essentials of Good Epidemiological Practice issued by Public Health Schweiz (EGEP), the Swiss Law and Swiss regulatory authority's requirements as applicable.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HD - Hemodialysis | – | –Patients with end stage renal disease treated with hemodialysis |
| PD - Peritoneal dialysis | – | –Patients with end stage renal disease treated with peritoneal dialysis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients from dialysis centers
Key inclusion criteria (1 listed)
- Dialysed patients (hemodialysis or peritoneal dialysis)
Key exclusion criteria (1 listed)
- -
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
Quality score
Time frame: baseline
To assess adherence to blood pressure measurement guidelines, a quality score is obtained from the surveys by assigning 1 point for each correct answer and 0 for the other one. The "perfect" and maximum score is 21. Higher scores indicate a better adherence to guidelines.
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 16 Mar 2018.
- Individual participant dataSharing planned: Undecided. it is planne to put IPD on zenodo Platform 1 year after publication
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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.
Grégoire Wuerzner, MD principal investigator
Centre Hospitalier Universitaire Vaudois
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 End Stage Renal Disease, run by PD Dr. Grégoire Wuerzner at 1 site in Switzerland.
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 1 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 16 Mar 2018. 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 Switzerland. 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.
What does the primary outcome measure?
Quality score (time frame: baseline). 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 16 Mar 2018.