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临床试验/NCT04491669
NCT04491669Unknown不适用

Screening of Gastrointestinal Tract Bleeding Causes Among Chronic Renal Failure Patients in Assuit University in a Single Study Center

Assiut University0 个研究点目标入组 100 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
主要终点
Assessment of different modalities of therapeutic intervention.

研究概览

简要总结

The aim of the current study is to screen different causes and characteristics of Gastrointestinal bleeding in Chronic Renal Failure patients at Assuit University Hospital according to their stages based on e GFR (Stage I to IV), in order to assess different modalities of therapeutic intervention from medical therapy up to therapeutic intervention.

详细描述

  • Chronic Renal Failure is defined as presence of reduced glomerular filtration rate (GFR) < 60 ml/min/ 1.73 m2 and/or evidence of kidney damage (usually indicated by albuminuria or proteinuria) for > 3 months or more irrespective of cause (Kiapidou et al., 2019).
  • Chronic Renal Failure stages are classified according to the National Kidney Foundation in to five stages according to estimated GFR (Ikizler 2009).
  • The prevalence of Chronic Renal Failure is continuously rising in concert with the rising epidemic of its risk factors including ageing, diabetes, obesity, metabolic syndrome, smoking, and hypertension (Stevens and Levin 2013).
  • Gastrointestinal bleeding, is all forms of bleeding in the gastrointestinal tract, from the mouth to the rectum. When there is significant blood loss over a short time, symptoms may include vomiting red blood, vomiting black blood, bloody stool, or black stool. Small amounts of bleeding over a long time may cause iron-deficiency anemia resulting in feeling tired or heart-related chest pain.

Other symptoms may include abdominal pain, shortness of breath, pale skin, or passing out. Sometimes in those with small amounts of bleeding no symptoms may be present. (Bong Sik Matthew Kim. 2014)

• Preliminary data suggest an association between Chronic Renal Failure and Gastrointestinal Bleeding. Individuals with even mild to moderate Chronic Renal Failure warrant clinical attention regarding the risk of hospitalization with Gastrointestinal bleeding. (Kunihiro Matsushita, 2016 Oct 7) reported that the prevalence of Gastrointestinal bleeding was significantly higher in patients with Chronic Renal Failure compared to patients without Chronic Renal Failure.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • One hundred Chronic Renal Failure patients with different stages (stage I to IV) according to the National Kidney Foundation are recruited from inpatients of renal unit in internal medicine department, Assuit university hospitals. Their GFR will assessed by using Chronic Renal Failure EPI equation measured as GFR=166 x(s cr/0.7)-1.209X(0.993)age if female, and GFR=163X(s cr/0.9)-1.209x(0.993)age if male. (Andrews et al 2008).
  • Chronic Renal Failure staging according to GFR by Chronic Renal Failure EPI is:
  • Stage1 in which GFR>90 mil/min but evidence of kidney damage.
  • Stage 2 GFR 60-89 mil/min.
  • Stage 3 GFR 30-95 mil/min.
  • Stage 4 GFR 15-29 mil/min.
  • Stage 5 GFR<15 mil/min.

排除标准

  • All Patients with local causes of Gastrointestinal Bleeding
  • Benign and Malignant tumors in Gastrointestinal Tract.
  • Patients with Hemorrhoids or anal fissures.
  • Patients with Mallory-Weiss tears.
  • patients with Diverticular disease.
  • patients with Colon polyps.
  • patients with infectious causes of GIT bleeding (Salmonella, Shigella)
  • patients with Angiodysplasia.
  • patients with Esophageal varices

结局指标

主要结局

Assessment of different modalities of therapeutic intervention.

时间窗: one year from October 2020 to October 2021

medical therapy up to therapeutic intervention data will be received.

次要结局

未报告次要终点

研究者

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

Mahmoud Elsayed Mustafa Hussein Mandour

Dr.

Assiut University

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