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临床试验/NCT04242979
NCT04242979Unknown不适用

Assessing of Physicians' Knowledge About International Guidelines of Albumin Use in Patients With Liver Cirrhosis

Abdelrahman Salah Eldin Abodief0 个研究点目标入组 1 人开始时间: 2020年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1
主要终点
Questionnaire

研究概览

简要总结

Due to shortage of local studies of the adherence of physicians to the guidelines for albumin use among patients with liver cirrhosis so this study aims to assess:

  1. Physicians' knowledge on the evidence-based indications for HA use supported by the international guidelines;
  2. Whether HA is used in clinical conditions not supported by solid scientific evidence;
  3. To formulate the evidence-based indications for HA use supported by the international guidelines and to evaluate effect of distributing these evidence-based indications on physicians' knowledge.

详细描述

  • In the last part of the previous century the increasing knowledge about the cardiovascular abnormalities that occur in advanced cirrhosis led researchers to design prospective randomized clinical trials assessing the effect of exogenous human albumin (HA) based on its well-established capacity to act as plasma-expander.
  • Due to the positive results reported by those studies, international guidelines have included the administration of HA among the recommendations for the prevention of post-paracentesis circulatory dysfunction (PPCD) or renal failure induced by spontaneous bacterial peritonitis (SBP), and for the diagnosis and treatment of hepatorenal syndrome (HRS) .
  • Indeed, all these complications are characterized by a substantial reduction of effective volemia. However, even in these settings, questions regarding HA dosage and whether or not all patients should be treated remain unanswered .
  • It has now become evident that circulatory dysfunction and organ damage in patients with decompensated cirrhosis are related to a chronic state of systemic inflammation and oxidative stress, which can abruptly exacerbate in patients developing acute-on-chronic liver failure (ACLF), a syndrome characterized by extra-hepatic organ failure and poor short-term survival.
  • Besides colloid-osmotic power, HA is provided with many biological properties unrelated to the regulation of fluid compartmentalization. Among these, some would assume particular importance in relation to the inflammatory state of decompensated cirrhosis, such as antioxidant and scavenging activities, binding and transport of many endogenous and exogenous substances, and regulation of endothelial function and inflammatory/immunological response .
  • Therefore, due to both its oncotic and non-oncotic properties, HA may exert beneficial effects at different steps of the cascade of the pathogenetic events that link circulatory dysfunction to systemic inflammation, providing a novel pathophysiological perspective for the use of HA. In this regard, two nationwide surveys on the use of HA in patients with cirrhosis conducted in the United States and France aiming to assess the adherence to the current AASLD and EASL guidelines respectively, have shown that HA is also prescribed besides the evidence-based indications. Indeed, HA is not rarely employed in non-SBP bacterial infections, severe hyponatremia, and hypoalbuminemia.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

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

入选标准

  • Gastroenterology physicians in:
  • Al-Rajhi Liver Hospital (Tropical Medicine Department, and Internal Medicine, GIT Unit).
  • Police Hospital.
  • Health Insurance Hospital.
  • Assiut Center for Management of HCV.
  • El - Shamla Hospital.
  • Al-Eman Hospital.

排除标准

  • Non gastroenterology physicians

结局指标

主要结局

Questionnaire

时间窗: 1 month

The investigators will know physicians' basic mean knowledge score about human albumin use in validated and non validated indications. The score will be from (0-2)

次要结局

  • Questionnaire(2-3 years)

研究者

发起方
Abdelrahman Salah Eldin Abodief
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Abdelrahman Salah Eldin Abodief

Principal Investigator

Assiut University

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