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临床试验/NCT06153888
NCT06153888招募中不适用

The Effect of Hemodialysis on proBNP

Umeå University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年3月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
2
主要终点
Change in NT-pro-BNP (proBNP)

研究概览

简要总结

Patients performing chronic hemodialysis (HD) retain more or less water between dialyses. The water is removed by ultrafiltration and usually during the cleansing of waste products - the HD. The length of HD is usually the same as the time of fluid removal while sometimes this may differ. There is no clear guideline. In previous research the investigator noted that the heart releases more NT-pro-BNP during HD in numerous of the patients.

The present study aims to clarify if the speed of fluid removal during HD is a factor that may alter the release of cardiac markers during HD. If so the recommendations for the prescription of HD can be updated.

详细描述

Research plan

ULtrafiltration-Rate Induced CArdiac strain (ULRICA) - study

Survey of the field:

Patients on chronic haemodialysis suffer from an increased risk for morbidity and mortality with the main cause of death being cardiovascular disease. Besides retention of uremic solutes, dialysis patients with poor urine output suffer from water retention. Excessive water retention results in inter dialytic weight gain (IDWG). IDWG is one prominent risk factor for cardiovascular events.

With time, the effects of uraemia and dialysis treatment itself cause a cardiac strain leading to an impact on cardiac function. In the course of chronic haemodialysis, a majority of the patients develop heart failure with preserved ejection fraction. Biomarkers for such clinical involvement are i.e., B-type natriuretic peptide (BNP), and Troponin.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult HD patients with an intra-dialytic weight gain (IDWG) ≥2.5% of target weight over the long interval (3 days) prior to inclusion.
  • Patients need to be able to understand the study information
  • Patients need to be able to give consent.

排除标准

  • Active systemic inflammatory state such as extensive malignancy or acute septic infection.
  • Uncontrolled hyperphosphatemia decided by the local routine of the physician (due to somewhat decreased efficacy of the low flux filter to eliminate phosphate)

结局指标

主要结局

Change in NT-pro-BNP (proBNP)

时间窗: Per patient: two dialyses within 8 days; Study period:1 year

The investigation focuses on the marker for cardiac strain pro-BNP (ng/L). Question: Does the heart get less release of markers for cardiac strain upon a slower speed of fluid removal.

次要结局

  • Adverse events(Per patient: two dialyses within 8 days; Study period:1 year)
  • Change in troponin T(Per patient: two dialyses within 8 days; Study period:1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bernd Stegmayr

Professor Emeritus

Umeå University

研究点 (2)

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