Blood Pressure Measurement in Dialysed Patients | NCT03318653

Studies
Blood Pressure Measurement in Dialysed Patients

NCT03318653

Sponsor

PD Dr. Grégoire Wuerzner

Status

Completed

Last Update Posted

Mar 16, 2018Actual

Enrollment

192Estimated

Phase

Not provided

Conditions

End Stage Renal Disease

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 20, 2017Actual

Primary Completion Date

Mar 15, 2018Actual

Completion Date

Mar 15, 2018Actual

First Submitted Date

Oct 19, 2017

First Submission Date that Met QC Criteria

Oct 19, 2017

First Posted Date

Oct 24, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 15, 2018

Last Update Posted Date

Mar 16, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

PD Dr. Grégoire Wuerzner, MD, privat docent, MER, Centre Hospitalier Universitaire VaudoisSponsor-Investigator

Lead Sponsor

PD Dr. Grégoire WuerznerOTHER

Collaborators

Name	Class
University Hospital, Geneva	OTHER
Universitair Ziekenhuis Brussel	OTHER
Cliniques universitaires Saint-Luc- Université Catholique de Louvain	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

192Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HD - Hemodialysis		Patients with end stage renal disease treated with hemodialysis
PD - Peritoneal dialysis		Patients with end stage renal disease treated with peritoneal dialysis

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Dialysed patients (hemodialysis or peritoneal dialysis)

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients from dialysis centers

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Grégoire Wuerzner, MD	Centre Hospitalier Universitaire Vaudois	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Universitaire Vaudois		Lausanne	Canton of Vaud	1011	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

it is planne to put IPD on zenodo Platform 1 year after publication

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007676	Kidney Failure, Chronic

Ancestor Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided