Clinical trial NCT03318653: Blood Pressure Measurement in Dialysed Patients
Official title: Adherence to Blood Pressure Measurement Guidelines for Patients With End-stage Renal Disease on Renal Replacement Therapy (hæmodialysis or Peritoneal Dialysis)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End Stage Renal Disease
Keywords: Blood pressure
Dialysis
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
Collaborators: name: University Hospital, Geneva
name: Universitair Ziekenhuis Brussel
name: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Royal Infirmary of Edinburgh
name: Central Hospital, Nancy, France
First posted: 2017-10-24
Enrollment: 192
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from dialysis centers

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.

Eligibility criteria: Inclusion Criteria:

* Dialysed patients (hemodialysis or peritoneal dialysis)

Exclusion Criteria:

-

Primary outcomes:
measure: Quality score
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
state: Vaud
Study officials:
affiliation: Centre Hospitalier Universitaire Vaudois
name: Grégoire Wuerzner, MD
role: PRINCIPAL_INVESTIGATOR
References: