<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/NCT03779750</url>
  </required_header>
  <id_info>
    <org_study_id>COESRDIPURHIAUH</org_study_id>
    <nct_id>NCT03779750</nct_id>
  </id_info>
  <brief_title>Causes Of End Stage Renal Disease In Patients Undergoing Regular Hemodialysis</brief_title>
  <official_title>CausesOf End Stage Renal Disease In Patients Undergoing Regular Hemodialysis In Assiut University Hospital</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>
      CKD is defined as kidney damage for ≥3 months, as defined by structural and or functional&#xD;
      abnormalities of the kidney, with or without decreased GFR or GFR &lt;60 mL/min/1.73m2 for ≥3&#xD;
      months, with or without kidney damage. CKD is classified based on cause, GFR category, and&#xD;
      albuminuria category (CGA). ESRD has become a public health problem worldwide, with recent&#xD;
      reports showing that the total number of ESRD patients has been growing dramatically.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The prevalence ESRD undergoing maintenance dialysis in 2010 was 284 individuals per million&#xD;
      population (pmp) worldwide, which has increased 1.7 times from 165 pmp patients in 1990.&#xD;
&#xD;
      In Egypt, the prevalence of dialysis patients has increased from 225 pmp in 1996 to 483 pmp&#xD;
      in 2008(according to last Egyptian renal registry) and the main causes of ESKD in Egypt,&#xD;
      other than diabetic nephropathy, included hypertensive kidney disease, chronic&#xD;
      glomerulonephritis, unknown etiology, chronic pyelonephritis, schistosomal obstructive&#xD;
      uropathy, and schistosomal nephropathy .&#xD;
&#xD;
      It is well established that diabetic kidney disease is the most common cause or in&#xD;
      combination with hypertensive nephropathy are the most common causes of end-stage renal&#xD;
      disease (ESRD) in developed and developing countries. Patient survival in diabetics on&#xD;
      maintenance renal replacement therapy including hemodialysis (HD), peritoneal dialysis (PD)&#xD;
      and kidney transplantation is significantly lower than that seen in nondiabetics with ESRD.&#xD;
      The poor prognosis of diabetic patients with ESRD is partly due to presence of significant&#xD;
      cardiovascular disease, problems with vascular access, more susceptible to infections, foot&#xD;
      ulcer, and hemodynamic instability during HD.&#xD;
&#xD;
      Hemodialysis (HD) is the first line of renal replacement therapy in the investigator's&#xD;
      country. It is well known that patients on RRT are of greater risk for complications and&#xD;
      worse prognosis in comparison to patients with the same co-morbidities but not on RRT.&#xD;
&#xD;
      The most common complicatons of hemodialysis are hypotensive episodes, muscular cramps,&#xD;
      itching, arrhythmias,and anaphylactic responses during the sessions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 1, 2019</start_date>
  <completion_date type="Anticipated">March 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>To find out the possible etiologies of ESRD in patients undergoing regular hemodialysis in Assiut university hospital.</measure>
    <time_frame>Within one year</time_frame>
    <description>prevalence of ESRD on regular hemodialysis(in percentage )among different age groups ( measured by years)&#xD;
frequencies(in percentage)of different etiologies in ESRD on regular hemodialysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To do registration for ESRD patients undergoing regular haemodialysis in assuit university hospital dialysis unit</measure>
    <time_frame>Within one year</time_frame>
    <description>• Relation between different causes of ESRD and life expectance.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>End Stage Renal Disease Patients</condition>
  <arm_group>
    <arm_group_label>End Stage Renal Disease Patients</arm_group_label>
    <description>complete blood picture blood urea s.creatinine urine analysis calcium phosphorus parathyroid hormone. 4- Hepatitis BsAg,HCV-Abs and HIV.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>s.creatinine</intervention_name>
    <description>All ESRD patients on regular hemodialysis in dialysis unit of Assiut university Hospital duing one year. will be subjected to 3- Routine investigations including complete blood picture ,blood urea , s.creatinine,urine analysis , calcium, phosphorus, and parathyroid hormone.</description>
    <arm_group_label>End Stage Renal Disease Patients</arm_group_label>
    <other_name>blood urea</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All ESRD patients on regular hemodialysis in dialysis unit of Assiut university Hospital&#xD;
        duing one year.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All ESRD patients &gt;18years old in Assuit University Hospital dialysis unit .&#xD;
&#xD;
          -  Patients on regular haemodialysis for more than six months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ESRD patients&lt;18years old .&#xD;
&#xD;
          -  patients with acute kidney injury .&#xD;
&#xD;
          -  patients on haemodialysis for less than six months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Mostafa A Haridy, Prof.Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Unaffiliation</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hudna A Ahmed, resident</last_name>
    <phone>00201096365187</phone>
    <email>hudna.abdullah@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Essam M Abdel Aziz, lecture Dr</last_name>
    <phone>00201009699081</phone>
    <email>essam.nephro@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Assiut University Hospital</name>
      <address>
        <city>Assiut</city>
        <zip>Assiut University71515</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <contact>
      <last_name>Hudna A Ahmed, Residant</last_name>
      <phone>00201096365187</phone>
      <email>hudna.abdullah@yahoo.com</email>
    </contact>
    <contact_backup>
      <last_name>Essam M Abdel Aziz, Doctor</last_name>
      <phone>00201009699081</phone>
      <email>essam.nephro@gmail.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Hudna Abdullah Ahmed</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Solomon R. PRESERVE: The End or the Beginning of a New Era in Prevention of Contrast-Associated Acute Kidney Injury? Am J Kidney Dis. 2018 Sep;72(3):322-324. doi: 10.1053/j.ajkd.2018.03.013. Epub 2018 May 8. No abstract available.</citation>
    <PMID>29751980</PMID>
  </reference>
  <reference>
    <citation>Thomas B, Wulf S, Bikbov B, Perico N, Cortinovis M, Courville de Vaccaro K, Flaxman A, Peterson H, Delossantos A, Haring D, Mehrotra R, Himmelfarb J, Remuzzi G, Murray C, Naghavi M. Maintenance Dialysis throughout the World in Years 1990 and 2010. J Am Soc Nephrol. 2015 Nov;26(11):2621-33. doi: 10.1681/ASN.2014101017. Epub 2015 Jul 24.</citation>
    <PMID>26209712</PMID>
  </reference>
  <reference>
    <citation>Ghaderian SB, Hayati F, Shayanpour S, Beladi Mousavi SS. Diabetes and end-stage renal disease; a review article on new concepts. J Renal Inj Prev. 2015 Jun 1;4(2):28-33. doi: 10.12861/jrip.2015.07. eCollection 2015.</citation>
    <PMID>26060834</PMID>
  </reference>
  <reference>
    <citation>Ikizler TA, Schulman G. Hemodialysis: techniques and prescription. Am J Kidney Dis. 2005 Nov;46(5):976-81. doi: 10.1053/j.ajkd.2005.07.037. No abstract available.</citation>
    <PMID>16253743</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>May 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 16, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 16, 2018</last_update_submitted>
  <last_update_submitted_qc>December 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Hudna abdullah</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03779750
org study id: COESRDIPURHIAUH
nct id: NCT03779750
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
CKD is defined as kidney damage for ≥3 months, as defined by structural and or functional
      abnormalities of the kidney, with or without decreased GFR or GFR <60 mL/min/1.73m2 for ≥3
      months, with or without kidney damage. CKD is classified based on cause, GFR category, and
      albuminuria category (CGA). ESRD has become a public health problem worldwide, with recent
      reports showing that the total number of ESRD patients has been growing dramatically.
The prevalence ESRD undergoing maintenance dialysis in 2010 was 284 individuals per million
      population (pmp) worldwide, which has increased 1.7 times from 165 pmp patients in 1990.

      In Egypt, the prevalence of dialysis patients has increased from 225 pmp in 1996 to 483 pmp
      in 2008(according to last Egyptian renal registry) and the main causes of ESKD in Egypt,
      other than diabetic nephropathy, included hypertensive kidney disease, chronic
      glomerulonephritis, unknown etiology, chronic pyelonephritis, schistosomal obstructive
      uropathy, and schistosomal nephropathy .

      It is well established that diabetic kidney disease is the most common cause or in
      combination with hypertensive nephropathy are the most common causes of end-stage renal
      disease (ESRD) in developed and developing countries. Patient survival in diabetics on
      maintenance renal replacement therapy including hemodialysis (HD), peritoneal dialysis (PD)
      and kidney transplantation is significantly lower than that seen in nondiabetics with ESRD.
      The poor prognosis of diabetic patients with ESRD is partly due to presence of significant
      cardiovascular disease, problems with vascular access, more susceptible to infections, foot
      ulcer, and hemodynamic instability during HD.

      Hemodialysis (HD) is the first line of renal replacement therapy in the investigator's
      country. It is well known that patients on RRT are of greater risk for complications and
      worse prognosis in comparison to patients with the same co-morbidities but not on RRT.

      The most common complicatons of hemodialysis are hypotensive episodes, muscular cramps,
      itching, arrhythmias,and anaphylactic responses during the sessions.
observational model: Cohort
time perspective: Prospective
measure: To find out the possible etiologies of ESRD in patients undergoing regular hemodialysis in Assiut university hospital.
time frame: Within one year
description: prevalence of ESRD on regular hemodialysis(in percentage )among different age groups ( measured by years)
frequencies(in percentage)of different etiologies in ESRD on regular hemodialysis.
measure: To do registration for ESRD patients undergoing regular haemodialysis in assuit university hospital dialysis unit
time frame: Within one year
description: • Relation between different causes of ESRD and life expectance.
arm group label: End Stage Renal Disease Patients
description: complete blood picture blood urea s.creatinine urine analysis calcium phosphorus parathyroid hormone. 4- Hepatitis BsAg,HCV-Abs and HIV.
intervention type: Diagnostic Test
intervention name: s.creatinine
description: All ESRD patients on regular hemodialysis in dialysis unit of Assiut university Hospital duing one year. will be subjected to 3- Routine investigations including complete blood picture ,blood urea , s.creatinine,urine analysis , calcium, phosphorus, and parathyroid hormone.
arm group label: End Stage Renal Disease Patients
other name: blood urea
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Mostafa A Haridy, Prof.Dr
role: Principal Investigator
affiliation: Unaffiliation
last name: Hudna A Ahmed, resident
phone: 00201096365187
email: hudna.abdullah@yahoo.com
last name: Essam M Abdel Aziz, lecture Dr
phone: 00201009699081
email: essam.nephro@gmail.com
facility: 
contact: 
contact backup: 
facility: 
country: Egypt
citation: Solomon R. PRESERVE: The End or the Beginning of a New Era in Prevention of Contrast-Associated Acute Kidney Injury? Am J Kidney Dis. 2018 Sep;72(3):322-324. doi: 10.1053/j.ajkd.2018.03.013. Epub 2018 May 8. No abstract available.
PMID: 29751980
citation: Thomas B, Wulf S, Bikbov B, Perico N, Cortinovis M, Courville de Vaccaro K, Flaxman A, Peterson H, Delossantos A, Haring D, Mehrotra R, Himmelfarb J, Remuzzi G, Murray C, Naghavi M. Maintenance Dialysis throughout the World in Years 1990 and 2010. J Am Soc Nephrol. 2015 Nov;26(11):2621-33. doi: 10.1681/ASN.2014101017. Epub 2015 Jul 24.
PMID: 26209712
citation: Ghaderian SB, Hayati F, Shayanpour S, Beladi Mousavi SS. Diabetes and end-stage renal disease; a review article on new concepts. J Renal Inj Prev. 2015 Jun 1;4(2):28-33. doi: 10.12861/jrip.2015.07. eCollection 2015.
PMID: 26060834
citation: Ikizler TA, Schulman G. Hemodialysis: techniques and prescription. Am J Kidney Dis. 2005 Nov;46(5):976-81. doi: 10.1053/j.ajkd.2005.07.037. No abstract available.
PMID: 16253743
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Hudna abdullah
investigator title: Principal Investigator
mesh term: Kidney Diseases
mesh term: Kidney Failure, Chronic
sharing ipd: Undecided