Orthostatic Hypotension and Blood Pressure Variability in Persons Undergoing Hemodialysis

NCT06348589 | Completed

• 1 other identifier: 2023-05959-01
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

High blood pressure is a risk factor for end-stage renal disease and is common in patients undergoing maintenance hemodialysis. Intradialytic hypotension is associated with an adverse prognosis. More knowledge is needed to identify patients at high risk for intradialytic hypotension and dialysis-associated hypotensive episodes. The aim of this observational single-center pilot study is to evaluate whether point-of-care ultrasound measurements may predict intradialytic hypotension and orthostatic blood pressure falls, in patients with chronic kidney disease who undergo maintenance hemodialysis.

Conditions

Chronic Kidney Disease Requiring Chronic Dialysis

Outcome Measures

Primary Outcomes (2)

• Intra-dialytic systolic blood pressure fall of 20 mmHg or larger

  Difference between pre-dialytic and intra-dialytic systolic blood pressure

  Up to 1 week

• Post-dialytic orthostatic systolic blood pressure fall of 20 mmHg or larger

  Change between supine and upright systolic blood pressure

  Up to 1 week

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients (n=70) with chronic kidney disease who undergo maintenance hemodialysis at Vrinnevi Hospital in Norrköping, Sweden, will be invited to voluntarily participate in the study.

You may qualify if:

• Patient undergoing hemodialysis treatment at Vrinnevi Hospital, Norrköping Sweden
• Provision of written informed consent
• Ability to understand instructions and to participate in the investigations

You may not qualify if:

• Ongoing acute illness
• Hospitalization within 4 weeks prior to enrollment
• Unability to provide informed consent

Sponsors & Collaborators

• Vrinnevi Hospital: lead

Study Sites (1)

Vrinnevi Hospital

Norrköping, Östergötland County, Sweden

Location

Study Officials

• Magnus O Wijkman, MD, PhD

  Vrinnevi Hospital, Department of Internal Medicine, Section of Endocrinology and Diabetology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Medically Responsible Physician at the Section for Endocrinology and Diabetology

Study Record Dates

• First Submitted: March 24, 2024
• First Posted: April 4, 2024
• Study Start: April 8, 2024
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)