Blood Pressure Measurement in Dialysed Patients

End Stage Renal Disease Clinical Trial

— DIALBP  

Official title:

Adherence to Blood Pressure Measurement Guidelines for Patients With End-stage Renal Disease on Renal Replacement Therapy (hæmodialysis or Peritoneal Dialysis)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03318653
• Other study ID #: 2017-00352
• Status: Completed
• Phase: N/A
• First received: October 19, 2017
• Last updated: March 15, 2018
• Start date: June 20, 2017
• Est. completion date: March 15, 2018

Study information

• Verified date: March 2018
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. The objective is to face the theoretical guideline with what is effectively done.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: March 15, 2018
• Est. primary completion date: March 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Dialysed patients (hemodialysis or peritoneal dialysis)

Exclusion Criteria:

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Locations

Country	Name	City	State
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne	Vaud

Sponsors (6)

Lead Sponsor	Collaborator
PD Dr. Grégoire Wuerzner	Central Hospital, Nancy, France, Cliniques universitaires Saint-Luc- Université Catholique de Louvain, Royal Infirmary of Edinburgh, Universitair Ziekenhuis Brussel, University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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