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BP Variability on the Outcomes of Hemodialysis Vascular Access

NCT04692636 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1300

Last updated 2021-01-05

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

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

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.

Sponsors & Collaborators

  • National Taiwan University Hospital Hsin-Chu Branch

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04692636 on ClinicalTrials.gov