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临床试验/NCT04157647
NCT04157647Unknown不适用

Monocentric Prospective Randomized Pilot Study in Patients With Kidney Failure to Evaluate the Relationship Between the Hemadsorption During and After Cardiopulmonary Bypass and the Modulation of Post-surgical Inflammatory Response

University Magna Graecia2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年11月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
2
主要终点
IL-6 concentration at ICU admission

研究概览

简要总结

Chronic kidney disease (CKD) is a risk factor for the development of cardiovascular disease, which increases the risk of death after cardiac surgery. High interleukin 6 (IL-6) blood levels is commonly observed in patients with CKD, and this is particularly high after cardiac surgery. High IL-6 levels are also associated with increased long-term mortality rate after cardiac surgery. To date, the use of ultrafiltration or endotoxin adsorption systems were not found to improve the clinical outcome, although able to reduce the inflammatory mediators concentrations. In the last years, a new extracorporeal hemadsorption filter (CytoSorb) has been developed for removal of inflammatory cytokines and it has been approved by the European Union. However, data lack about the impact on clinical outcome of the use of CytoSorb in patients with CKD undergoing cardiac surgery with cardio-pulmonary bypass (CPB). The investigators have therefore designed this pilot prospective randomized trial to evaluate the efficacy the intraoperative use of CytoSorb for cytokines removal to prevent the inflammatory response associated with the cardiac surgery and complications in patients with CKD.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • All consecutive adult patients (age >65 years) undergoing cardiac surgery with an anticipated CPB time duration longer than 60 minutes.
  • Presence of CKD defined by a Glomerular Filtration Rate (eGFR) < 60 ml/min/1.73 m
  • Consent to participate to the study

排除标准

  • emergency surgery
  • acute infective endocarditis
  • systemic infectious diseases
  • previous kidney transplant
  • need for contrast enhancement during surgery
  • immunosuppressive or long-term corticosteroid therapies
  • participation to other investigations.

结局指标

主要结局

IL-6 concentration at ICU admission

时间窗: At day 0 after surgery

Investigators will assess the blood IL-6 concentrations between the two arms

次要结局

  • IL-6 concentration before cardiac surgery(At day 0 before the cardiac surgery)
  • Liver transaminases concentration(daily up to day 15)
  • Haptoglobin concentration(daily up to day 15)
  • IL-6 concentration at the end of CardioPulmonary Bypass(At day 0 at the end of the CardioPulmonary Bypass)
  • IL-6 concentration 48 hours after the end of CardioPulmonary Bypass(48 hours after the end of CardioPulmonary Bypass)
  • IL-6 concentration 2 hours after the end of CardioPulmonary Bypass(2 hours after the end of CardioPulmonary Bypass)
  • Renal function(daily up to day 15)
  • Myoglobin concentration(daily up to day 15)
  • Osteopontin concentration(daily up to day 15)
  • Free hemoglobin concentration(daily up to day 15)

研究者

发起方
University Magna Graecia
申办方类型
Other
责任方
Principal Investigator
主要研究者

GIUSEPPE FILIBERTO SERRAINO

Principal Investigator

University Magna Graecia

研究点 (2)

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