BP Variability on the Outcomes of Hemodialysis Vascular Access

NCT04692636 | Unknown

• 1 other identifier: 106-033-E
• Study Type: observational
• Target: 1,300
• Locations: 1 country
• Sites: 1

Brief Summary

Hemodialysis vascular access dysfunction continues to be a major source of morbidity and mortality in patients with ESRD. Thrombosis is the most common cause of secondary vascular access failure Although intimal hyperplasia at the outflow vein is the most common cause of thrombosis, 20-40% of thrombosis may develop secondary without underlying anatomic abnormalities. Low-flow states secondary to low BP have been proposed to precipitate access thrombosis. In previous studies, lower pre- and post- dialysis SBP are associated with a higher rate of access thrombosis. Nonetheless, high blood pressure is also a well-known risk factor for arteriosclerosis, intimal hyperplasia, and thrombotic vascular events. In dialysis patients, the relation between blood pressure and thrombosis seems to be more complex, and few studies have delineated the effect of blood pressure in a systematic manner. In addition to the static component of blood pressure, blood pressure variability (BPV) is increasingly accepted as a novel risk factors for vascular disease. BPV is categorized as either long or short term. In dialysis patients, long-term BPV is typically defined on the basis of BP measurements taken at the start of hemodialysis (inter-dialysis BPV); short-term BPV is usually considered in terms of variability during hemodialysis (intra-dialysis BPV). BP variability is increased in ESRD patients and is associated with adverse outcomes. To the best of our knowledge, only one study by Cheung et al focused on intra-dialytic BPV, which found intradialytic hypotension to be a risk factor for access thrombosis. Nonetheless, access thrombotic events rarely occur during the dialysis session. It remained unclear that if inter-dialysis BPV is a more relevant factor for access thrombosis. Answer to this question is of clinical significance because the optimal BP target after PTA remained unknown. In this study, we aimed to investigate the effect of BP variability on the outcomes of hemodialysis vascular access, major cardiovascular events in maintenance hemodialysis patients. We also aimed to evaluate the determinants of BPV in hemodialysis patients, including medication, frailty, fluid status and autonomic function. The impact of autonomic function and frailty on the outcomes of vascular access and cardiovascular events will be evaluated as well.

Conditions

Hemodialysis Access Failure; Blood Pressure; Dialysis Access Malfunction

Keywords

hemodialysis access failure; blood pressure

Outcome Measures

Primary Outcomes (1)

• Vascular access thrombosis

  An access that had clotted without blood flow

  30 months

Secondary Outcomes (4)

• Post-intervention primary patency

  30 months

• Post-intervention secondary patency

  30 months

• stroke (both ICH and infarction)

  5 years

• major cardiovascular events

  5 years

Other Outcomes (3)

• impact of frailty on vascular access events

  30 months

• impact of frailty on vascular access thrombosis

  30 months

• impact of frailty on cardiovascular events

  5 years

Study Arms (1)

Total study cohort

Patients with dysfunctional hemodialysis vascular access referred for PTA or patients who received maintenance hemodialysis will be prospectively enrolled.

Diagnostic Test: Measure: BP measurements, inter-dialysis BP variability, intra-dialysis hypotension

Interventions

Measure: BP measurements, inter-dialysis BP variability, intra-dialysis hypotension DIAGNOSTIC_TEST

BP will be measured at the beginning and end of each dialysis session in a seated position by a trained dialysis nurse in accordance with the routine unit practice and entered into an electronic database. BP was measured using validated oscillometric BP monitor equipped in hemodialysis machines (Fresenius 4008S or Nikisso DBB-05), which were maintained as per dialysis unit protocols.

Total study cohort

Eligibility Criteria

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

Study Population

Patients with dysfunctional hemodialysis vascular access referred for PTA or patients who received maintenance hemodialysis will be prospectively enrolled.

You may qualify if:

• age from 20-99 years old, undergoing regular hemodialysis for at least six months.

You may not qualify if:

• (1) patients received regular dialysis less than 6 months
• (2) patients with clinical evidence of acute or chronic inflammation, decompensated heart failure, recent myocardial infarction, or unstable angina in recent 3 months

Sponsors & Collaborators

• National Taiwan University Hospital Hsin-Chu Branch: lead

Study Sites (1)

National Taiwan University Hospital Hsinchu Branch

Hsinchu, Taiwan

RECRUITING

Related Publications (1)

• Hsieh MY, Chuang SY, Lee CK, Luo CM, Cheng CH, Liao MT, Lin PL, Yang TF, Wu CC. Risks and outcomes of critical limb ischemia in hemodialysis patients: a prospective cohort study. Clin Kidney J. 2022 Dec 8;16(3):585-595. doi: 10.1093/ckj/sfac263. eCollection 2023 Mar.

  PMID: 36865012 DERIVED

Central Study Contacts

Mu-Yang Hsieh, M.D.

CONTACT

+88635326151; h11135@hch.gov.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2020
• First Posted: January 5, 2021
• Study Start: January 1, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 5, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)