<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04491669</url>
  </required_header>
  <id_info>
    <org_study_id>GIT bleeding among CKD</org_study_id>
    <nct_id>NCT04491669</nct_id>
  </id_info>
  <brief_title>Screening of Gastrointestinal Tract Bleeding Causes Among Chronic Renal Failure Patients</brief_title>
  <official_title>Screening of Gastrointestinal Tract Bleeding Causes Among Chronic Renal Failure Patients in Assuit University in a Single Study Center</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the current study is to screen different causes and characteristics of&#xD;
      Gastrointestinal bleeding in Chronic Renal Failure patients at Assuit University Hospital&#xD;
      according to their stages based on e GFR (Stage I to IV), in order to assess different&#xD;
      modalities of therapeutic intervention from medical therapy up to therapeutic intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  Chronic Renal Failure is defined as presence of reduced glomerular filtration rate (GFR)&#xD;
           &lt; 60 ml/min/ 1.73 m2 and/or evidence of kidney damage (usually indicated by albuminuria&#xD;
           or proteinuria) for &gt; 3 months or more irrespective of cause (Kiapidou et al., 2019).&#xD;
&#xD;
        -  Chronic Renal Failure stages are classified according to the National Kidney Foundation&#xD;
           in to five stages according to estimated GFR (Ikizler 2009).&#xD;
&#xD;
        -  The prevalence of Chronic Renal Failure is continuously rising in concert with the&#xD;
           rising epidemic of its risk factors including ageing, diabetes, obesity, metabolic&#xD;
           syndrome, smoking, and hypertension (Stevens and Levin 2013).&#xD;
&#xD;
        -  Gastrointestinal bleeding, is all forms of bleeding in the gastrointestinal tract, from&#xD;
           the mouth to the rectum. When there is significant blood loss over a short time,&#xD;
           symptoms may include vomiting red blood, vomiting black blood, bloody stool, or black&#xD;
           stool. Small amounts of bleeding over a long time may cause iron-deficiency anemia&#xD;
           resulting in feeling tired or heart-related chest pain.&#xD;
&#xD;
      Other symptoms may include abdominal pain, shortness of breath, pale skin, or passing out.&#xD;
      Sometimes in those with small amounts of bleeding no symptoms may be present. (Bong Sik&#xD;
      Matthew Kim. 2014)&#xD;
&#xD;
      • Preliminary data suggest an association between Chronic Renal Failure and Gastrointestinal&#xD;
      Bleeding. Individuals with even mild to moderate Chronic Renal Failure warrant clinical&#xD;
      attention regarding the risk of hospitalization with Gastrointestinal bleeding. (Kunihiro&#xD;
      Matsushita, 2016 Oct 7) reported that the prevalence of Gastrointestinal bleeding was&#xD;
      significantly higher in patients with Chronic Renal Failure compared to patients without&#xD;
      Chronic Renal Failure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 1, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of different modalities of therapeutic intervention.</measure>
    <time_frame>one year from October 2020 to October 2021</time_frame>
    <description>medical therapy up to therapeutic intervention data will be received.</description>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>CKD</condition>
  <condition>GIT - Gastrointestinal Tract Hemorrhage</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>GFR - Glomerular Filtration Rate</intervention_name>
    <description>Chronic Renal Failure staging according to GFR by Chronic Renal Failure EPI is:&#xD;
Stage1 in which GFR&gt;90 mil/min but evidence of kidney damage.&#xD;
Stage 2 GFR 60-89 mil/min.&#xD;
Stage 3 GFR 30-95 mil/min.&#xD;
Stage 4 GFR 15-29 mil/min.&#xD;
Stage 5 GFR&lt;15 mil/min.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Chronic Renal Failure patients with different stages (stage I to IV) according to the&#xD;
        National Kidney Foundation are recruited from inpatients of renal unit in internal medicine&#xD;
        department, Assuit university hospitals.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  One hundred Chronic Renal Failure patients with different stages (stage I to IV)&#xD;
             according to the National Kidney Foundation are recruited from inpatients of renal&#xD;
             unit in internal medicine department, Assuit university hospitals. Their GFR will&#xD;
             assessed by using Chronic Renal Failure EPI equation measured as GFR=166 x(s&#xD;
             cr/0.7)-1.209X(0.993)age if female, and GFR=163X(s cr/0.9)-1.209x(0.993)age if male.&#xD;
             (Andrews et al 2008).&#xD;
&#xD;
        Chronic Renal Failure staging according to GFR by Chronic Renal Failure EPI is:&#xD;
&#xD;
          -  Stage1 in which GFR&gt;90 mil/min but evidence of kidney damage.&#xD;
&#xD;
          -  Stage 2 GFR 60-89 mil/min.&#xD;
&#xD;
          -  Stage 3 GFR 30-95 mil/min.&#xD;
&#xD;
          -  Stage 4 GFR 15-29 mil/min.&#xD;
&#xD;
          -  Stage 5 GFR&lt;15 mil/min.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  All Patients with local causes of Gastrointestinal Bleeding&#xD;
&#xD;
               -  Benign and Malignant tumors in Gastrointestinal Tract.&#xD;
&#xD;
               -  Patients with Hemorrhoids or anal fissures.&#xD;
&#xD;
               -  Patients with Mallory-Weiss tears.&#xD;
&#xD;
               -  patients with Diverticular disease.&#xD;
&#xD;
               -  patients with Colon polyps.&#xD;
&#xD;
               -  patients with infectious causes of GIT bleeding (Salmonella, Shigella)&#xD;
&#xD;
               -  patients with Angiodysplasia.&#xD;
&#xD;
               -  patients with Esophageal varices&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Effat AH Tony, Prof. Dr.</last_name>
    <role>Study Chair</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mahmoud EMH Mandou</last_name>
    <phone>00201006810538</phone>
    <email>m1234mandour@outlook.com</email>
  </overall_contact>
  <reference>
    <citation>Barkun AN, Bardou M, Kuipers EJ, Sung J, Hunt RH, Martel M, Sinclair P; International Consensus Upper Gastrointestinal Bleeding Conference Group. International consensus recommendations on the management of patients with nonvariceal upper gastrointestinal bleeding. Ann Intern Med. 2010 Jan 19;152(2):101-13. doi: 10.7326/0003-4819-152-2-201001190-00009.</citation>
    <PMID>20083829</PMID>
  </reference>
  <reference>
    <citation>Zuccaro G Jr. Management of the adult patient with acute lower gastrointestinal bleeding. American College of Gastroenterology. Practice Parameters Committee. Am J Gastroenterol. 1998 Aug;93(8):1202-8. doi: 10.1111/j.1572-0241.1998.00395.x. No abstract available.</citation>
    <PMID>9707037</PMID>
  </reference>
  <reference>
    <citation>Kim BS, Li BT, Engel A, Samra JS, Clarke S, Norton ID, Li AE. Diagnosis of gastrointestinal bleeding: A practical guide for clinicians. World J Gastrointest Pathophysiol. 2014 Nov 15;5(4):467-78. doi: 10.4291/wjgp.v5.i4.467.</citation>
    <PMID>25400991</PMID>
  </reference>
  <reference>
    <citation>Stevens PE, Levin A; Kidney Disease: Improving Global Outcomes Chronic Kidney Disease Guideline Development Work Group Members. Evaluation and management of chronic kidney disease: synopsis of the kidney disease: improving global outcomes 2012 clinical practice guideline. Ann Intern Med. 2013 Jun 4;158(11):825-30. doi: 10.7326/0003-4819-158-11-201306040-00007.</citation>
    <PMID>23732715</PMID>
  </reference>
  <reference>
    <citation>Ishigami J, Matsushita K. Clinical epidemiology of infectious disease among patients with chronic kidney disease. Clin Exp Nephrol. 2019 Apr;23(4):437-447. doi: 10.1007/s10157-018-1641-8. Epub 2018 Sep 3. Erratum In: Clin Exp Nephrol. 2019 Mar 2;:</citation>
    <PMID>30178234</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 25, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>July 28, 2020</last_update_submitted>
  <last_update_submitted_qc>July 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mahmoud Elsayed Mustafa Hussein Mandour</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastrointestinal Hemorrhage</mesh_term>
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04491669
org study id: GIT bleeding among CKD
nct id: NCT04491669
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
-  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.
observational model: Case-Only
time perspective: Retrospective
measure: Assessment of different modalities of therapeutic intervention.
time frame: one year from October 2020 to October 2021
description: medical therapy up to therapeutic intervention data will be received.
intervention type: Diagnostic Test
intervention name: GFR - Glomerular Filtration Rate
description: 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.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Effat AH Tony, Prof. Dr.
role: Study Chair
affiliation: Assiut University
last name: Mahmoud EMH Mandou
phone: 00201006810538
email: m1234mandour@outlook.com
citation: Barkun AN, Bardou M, Kuipers EJ, Sung J, Hunt RH, Martel M, Sinclair P; International Consensus Upper Gastrointestinal Bleeding Conference Group. International consensus recommendations on the management of patients with nonvariceal upper gastrointestinal bleeding. Ann Intern Med. 2010 Jan 19;152(2):101-13. doi: 10.7326/0003-4819-152-2-201001190-00009.
PMID: 20083829
citation: Zuccaro G Jr. Management of the adult patient with acute lower gastrointestinal bleeding. American College of Gastroenterology. Practice Parameters Committee. Am J Gastroenterol. 1998 Aug;93(8):1202-8. doi: 10.1111/j.1572-0241.1998.00395.x. No abstract available.
PMID: 9707037
citation: Kim BS, Li BT, Engel A, Samra JS, Clarke S, Norton ID, Li AE. Diagnosis of gastrointestinal bleeding: A practical guide for clinicians. World J Gastrointest Pathophysiol. 2014 Nov 15;5(4):467-78. doi: 10.4291/wjgp.v5.i4.467.
PMID: 25400991
citation: Stevens PE, Levin A; Kidney Disease: Improving Global Outcomes Chronic Kidney Disease Guideline Development Work Group Members. Evaluation and management of chronic kidney disease: synopsis of the kidney disease: improving global outcomes 2012 clinical practice guideline. Ann Intern Med. 2013 Jun 4;158(11):825-30. doi: 10.7326/0003-4819-158-11-201306040-00007.
PMID: 23732715
citation: Ishigami J, Matsushita K. Clinical epidemiology of infectious disease among patients with chronic kidney disease. Clin Exp Nephrol. 2019 Apr;23(4):437-447. doi: 10.1007/s10157-018-1641-8. Epub 2018 Sep 3. Erratum In: Clin Exp Nephrol. 2019 Mar 2;:
PMID: 30178234
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Mahmoud Elsayed Mustafa Hussein Mandour
investigator title: Dr.
mesh term: Gastrointestinal Hemorrhage
mesh term: Renal Insufficiency
mesh term: Kidney Failure, Chronic
mesh term: Hemorrhage
sharing ipd: No