xml: <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/NCT06034717</url>
    </required_header>
    <id_info>
      <org_study_id>observational</org_study_id>
      <nct_id>NCT06034717</nct_id>
    </id_info>
    <brief_title>Primary Patency in Pediatric Patients With Hemodialysis Access</brief_title>
    <official_title>Mid Term&amp;Short Term Outcomes in Pediatric Patients With Hemodialysis Access</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Alaa Gameil Abd El-salam Hussien</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Assiut University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Vascular access in the pediatric hemodialysis patients is a challenging,but necessary. It&#xD;
        requires proper advance planning to assure that the best permanent access is placeds long&#xD;
        life span. It is imperative to have a long-term vision to decrease morbidity in this unique&#xD;
        patient population.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Recent data indicate that the incidence of end stage renal disease (ESRD) in pediatrics has&#xD;
        increased over the past two decades[1]. Hemodialysis continues to be the most frequently&#xD;
        utilized modality for renal replacement therapy in pediatric ESRD patients One of the most&#xD;
        challenging aspects of kidney replacement therapy in children is the creation and maintenance&#xD;
        of a functioning vascular access to provide adequate blood flow for uremic solute removal&#xD;
        during haemodialysis, whilst minimizing the risk of systemic infections and preserving&#xD;
        vascular access choices for future dialysis. There are three common forms of vascularaccess:&#xD;
        tunnelled cuffed lines placed in a central vein, arteriovenous fistulas and arteriovenous&#xD;
        grafts using prosthetic or biological material. arterio-venous&#xD;
        fistula&quot;nativevascularaccesses&quot; are the preferred vascularaccess for children on&#xD;
        hemodialysis. Compared with a CVL, a functional artirio-venous fistula is associated with&#xD;
        better dialysis adequacy,significantly lowering complication rates and access&#xD;
        failure.However, CVLs remain the most frequently used vascular access in all paediatric age&#xD;
        groups, despite international recommendations[1-4] pediatrics with ESRD from age (1-6years)&#xD;
        start with peritoneal dialysis, and then from age (6-18years) start to use hemodialysis The&#xD;
        'ideal artrio-venous fistula ' is made distally in the non-dominant arm,e.g. a radiocephalic&#xD;
        AVF, and suitable vessels are veins&gt;2 mm and arteries &gt; 1 mm [5,6]. Apart from vessel&#xD;
        size,many other factors should be considered when deciding which access to create e.g.&#xD;
        psychological preparation of the child/parent, surgical expertise, child size/weight, quality&#xD;
        of veins,cosmetic concerns for the teenager and hand dominance for the child who wishes to&#xD;
        self-cannulate. Maintaining the confidence of the child, parent and dialysis nursing team is&#xD;
        vitalwhen forming the access.&#xD;
  &#xD;
        thisisdone by the aid ofduplexultrasound to assess size of&#xD;
        vein,sizeofartery,patencyofcentralvenoussystem physical examination to assess blood pressure&#xD;
        it's important to maintain blood pressure &gt;120,&lt;160 to allow patency of vascular access.All&#xD;
        thisisimportant tominimize/avoid the prolonged use of CVCs due to risks ofinfection and the&#xD;
        need for vessel preservation. we need to use good clinical judgment when choosing the&#xD;
        appropriate vascular access in each patient.&#xD;
  &#xD;
        possible complications that can occur affecting patency of vascular access include:&#xD;
  &#xD;
          1. Stenosis(Stenosis is a common complication which may affect the function of an AVF, it&#xD;
             is the main cause of arterio-venousfistula thrombosis and failure) [7]&#xD;
  &#xD;
             . Factors that predispose to the formation of venous neo-intimal hyperplasia and&#xD;
             stenoses include the Following: surgical injury, recurrent traumatic cannulaltion&#xD;
             (leading to defective vascularre modelling), high blood flow inducing endothelial cell&#xD;
             dysfunction andshear stress. Stenoses commonly present clinically with inadequate pump&#xD;
             speed, poor dialysis adequacy or a prolonged post-dialysis bleeding time. Physical&#xD;
             examination should be correlated with a Doppler ultrasound assessment to investigate any&#xD;
             clinically significant stenosis. In the absence of any clinical issues, an&#xD;
             arterio-venous fistula stenosis is considered significant if there is &gt;20% reduction&#xD;
             from baseline volume&#xD;
  &#xD;
          2. arterio-venous fistula thrombosis Acute vascularaccess thrombosis accounts for 20-25% of&#xD;
             all hospitalizations for hemodialysis patients and this leads to considerable morbidity&#xD;
             and cost to healthcare providers. [8, 9] An important consideration in preventing early&#xD;
             thrombosis peri-arterio-venousfistula formation is to maintain adequate intravascular&#xD;
             voume. This can be achieved by reducing the ultrafiltration for a few haemodialysis&#xD;
             sessions just after arterio-venous fistula creation and allowing permissive&#xD;
             hypertension. Adjusting anti hypertensive treatment in this early post-operative period&#xD;
             to maintainbloodpressure(&gt;130). D-dimers may help guide anti-thrombotic therapy and&#xD;
             prevent clotting.In a paediatric study, the levels of D-dimers were inversely correlated&#xD;
             with patency rates -based protocol to prevent early arterio-venous fistula failure&#xD;
             compared with historical controls and showed a lower rate of early thrombosis .&#xD;
  &#xD;
          3. Infections Infection rates for native and synthetic vascularaccess are substantially&#xD;
             lower (up to 10 times) than those for CVLs.. Importantly, 80% of the vascular accesses&#xD;
             remained functional after treating the infection[10].&#xD;
  &#xD;
        Haemodynamic issues High-output cardiac failure is occasionally seen in adults but is&#xD;
        uncommon in children and is managed with arterio-venous fistula volume flow reduction . Steal&#xD;
        syndrome ] occurs when a significant proportion of cardiac output is diverted from the&#xD;
        distalcapillary bed by the proximal arterio-venous fistula, causing distal ischemia [11,12].&#xD;
        This is also rare but may require surgical revision to preserve the access and alleviate the&#xD;
        distal ischaemia.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">October 1, 2022</start_date>
    <completion_date type="Anticipated">September 28, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 28, 2023</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>The aim of this study is to follow up Short term &quot;3-6 months&quot;&amp; Mid term&quot; 6-12months &quot;outcomes of Vascular access&quot; native and synthetic &quot;in ESRD pediatrics</measure>
      <time_frame>from 1october 2022to 28september 2023</time_frame>
      <description>evaluation of short term &quot;3-6months&quot; and Mid term &quot;6-12months&quot; outcomes, patterns of complication in pediatrics with hemodialysis access(time frame one year after surgey) Primary (unassisted) patency The interval from the time of access creation until the first access thrombosis or any intervention to maintain or restore blood flow</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>2ry patency</measure>
      <time_frame>from 1october 2022to 28september 2023</time_frame>
      <description>To identify possible complications&amp;how to avoid Secondary (cumulative) patency &quot;The time from access creation until access abandonment&quot;.&#xD;
  Functional secondary patency&quot; The interval from the first successful two-needle cannulation for haemodialysis treatment to access abandonment&quot; possible complications include:&#xD;
  Stenosis&#xD;
  thrombosis&#xD;
  Infections</description>
    </secondary_outcome>
    <enrollment type="Anticipated">60</enrollment>
    <condition>The Aim of This Study is to Follow up Short Term &quot;3-6 Months&quot;&amp; Mid Term&quot; 6-12months &quot;Outcomes of Vascular Access&quot; Native and Synthetic &quot;in ESRD Pediatrics</condition>
    <biospec_retention>None Retained</biospec_retention>
    <biospec_descr>
      <textblock>
        pediatric patients with hemodialysis access&#xD;
  &#xD;
        All data will be collected from the study patients by the applicant. most data will be&#xD;
        related to the patient's relative risk factors, duplex US,and physical examination and&#xD;
        investigations. the operative details and data related to the post management follow up. this&#xD;
        will be done under close supervision of my supervisors at the department of Vascular &amp;&#xD;
        EndovascularSurgery, Assiut University Hospitals&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          All patients fulfilling the inclusion and exclusion criteria will be included in this study&#xD;
          with time frame 1year&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  ) Ages :6-18 2) gender: All 3) Children on regular dialysis 4)children with duplex&#xD;
               criteria including: vein &gt;2mm artery&gt;1mm patent , respirophasic central venous system&#xD;
               5) children's parents compliance to follow-up.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          1)Children with ESRD contraindicated for vascular intervention including: Children with&#xD;
          resistance hyper-tention Children with medical history of bleeding tendency Children with&#xD;
          hyper-coagulable state 2)children with duplex criteria including: vein fibrotic &quot;&lt;2mm&quot;&#xD;
          artery&lt;1mm occluded central veins 3)Children's parents not compliance to follow up&#xD;
  &#xD;
          -&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Assuit university hospital</name>
        <address>
          <city>Assiut</city>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <link>
      <url>http://www.usrds.org/2019/download/USRDS_2019_ES_final.pdf,Accessed09June2020</url>
      <description>Related Info</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Alaa Gameil Abd El-salam Hussien</investigator_full_name>
      <investigator_title>: Alaa Gameil Abd El-salam Hussien</investigator_title>
    </responsible_party>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06034717
  org study id: observational
  nct id: NCT06034717
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Vascular access in the pediatric hemodialysis patients is a challenging,but necessary. It
        requires proper advance planning to assure that the best permanent access is placeds long
        life span. It is imperative to have a long-term vision to decrease morbidity in this unique
        patient population.
  Recent data indicate that the incidence of end stage renal disease (ESRD) in pediatrics has
        increased over the past two decades[1]. Hemodialysis continues to be the most frequently
        utilized modality for renal replacement therapy in pediatric ESRD patients One of the most
        challenging aspects of kidney replacement therapy in children is the creation and maintenance
        of a functioning vascular access to provide adequate blood flow for uremic solute removal
        during haemodialysis, whilst minimizing the risk of systemic infections and preserving
        vascular access choices for future dialysis. There are three common forms of vascularaccess:
        tunnelled cuffed lines placed in a central vein, arteriovenous fistulas and arteriovenous
        grafts using prosthetic or biological material. arterio-venous
        fistula"nativevascularaccesses" are the preferred vascularaccess for children on
        hemodialysis. Compared with a CVL, a functional artirio-venous fistula is associated with
        better dialysis adequacy,significantly lowering complication rates and access
        failure.However, CVLs remain the most frequently used vascular access in all paediatric age
        groups, despite international recommendations[1-4] pediatrics with ESRD from age (1-6years)
        start with peritoneal dialysis, and then from age (6-18years) start to use hemodialysis The
        'ideal artrio-venous fistula ' is made distally in the non-dominant arm,e.g. a radiocephalic
        AVF, and suitable vessels are veins>2 mm and arteries > 1 mm [5,6]. Apart from vessel
        size,many other factors should be considered when deciding which access to create e.g.
        psychological preparation of the child/parent, surgical expertise, child size/weight, quality
        of veins,cosmetic concerns for the teenager and hand dominance for the child who wishes to
        self-cannulate. Maintaining the confidence of the child, parent and dialysis nursing team is
        vitalwhen forming the access.
  
        thisisdone by the aid ofduplexultrasound to assess size of
        vein,sizeofartery,patencyofcentralvenoussystem physical examination to assess blood pressure
        it's important to maintain blood pressure >120,<160 to allow patency of vascular access.All
        thisisimportant tominimize/avoid the prolonged use of CVCs due to risks ofinfection and the
        need for vessel preservation. we need to use good clinical judgment when choosing the
        appropriate vascular access in each patient.
  
        possible complications that can occur affecting patency of vascular access include:
  
          1. Stenosis(Stenosis is a common complication which may affect the function of an AVF, it
             is the main cause of arterio-venousfistula thrombosis and failure) [7]
  
             . Factors that predispose to the formation of venous neo-intimal hyperplasia and
             stenoses include the Following: surgical injury, recurrent traumatic cannulaltion
             (leading to defective vascularre modelling), high blood flow inducing endothelial cell
             dysfunction andshear stress. Stenoses commonly present clinically with inadequate pump
             speed, poor dialysis adequacy or a prolonged post-dialysis bleeding time. Physical
             examination should be correlated with a Doppler ultrasound assessment to investigate any
             clinically significant stenosis. In the absence of any clinical issues, an
             arterio-venous fistula stenosis is considered significant if there is >20% reduction
             from baseline volume
  
          2. arterio-venous fistula thrombosis Acute vascularaccess thrombosis accounts for 20-25% of
             all hospitalizations for hemodialysis patients and this leads to considerable morbidity
             and cost to healthcare providers. [8, 9] An important consideration in preventing early
             thrombosis peri-arterio-venousfistula formation is to maintain adequate intravascular
             voume. This can be achieved by reducing the ultrafiltration for a few haemodialysis
             sessions just after arterio-venous fistula creation and allowing permissive
             hypertension. Adjusting anti hypertensive treatment in this early post-operative period
             to maintainbloodpressure(>130). D-dimers may help guide anti-thrombotic therapy and
             prevent clotting.In a paediatric study, the levels of D-dimers were inversely correlated
             with patency rates -based protocol to prevent early arterio-venous fistula failure
             compared with historical controls and showed a lower rate of early thrombosis .
  
          3. Infections Infection rates for native and synthetic vascularaccess are substantially
             lower (up to 10 times) than those for CVLs.. Importantly, 80% of the vascular accesses
             remained functional after treating the infection[10].
  
        Haemodynamic issues High-output cardiac failure is occasionally seen in adults but is
        uncommon in children and is managed with arterio-venous fistula volume flow reduction . Steal
        syndrome ] occurs when a significant proportion of cardiac output is diverted from the
        distalcapillary bed by the proximal arterio-venous fistula, causing distal ischemia [11,12].
        This is also rare but may require surgical revision to preserve the access and alleviate the
        distal ischaemia.
  observational model: Cohort
  time perspective: Prospective
  measure: The aim of this study is to follow up Short term "3-6 months"& Mid term" 6-12months "outcomes of Vascular access" native and synthetic "in ESRD pediatrics
  time frame: from 1october 2022to 28september 2023
  description: evaluation of short term "3-6months" and Mid term "6-12months" outcomes, patterns of complication in pediatrics with hemodialysis access(time frame one year after surgey) Primary (unassisted) patency The interval from the time of access creation until the first access thrombosis or any intervention to maintain or restore blood flow
  measure: 2ry patency
  time frame: from 1october 2022to 28september 2023
  description: To identify possible complications&how to avoid Secondary (cumulative) patency "The time from access creation until access abandonment".
  Functional secondary patency" The interval from the first successful two-needle cannulation for haemodialysis treatment to access abandonment" possible complications include:
  Stenosis
  thrombosis
  Infections
  pediatric patients with hemodialysis access
  
        All data will be collected from the study patients by the applicant. most data will be
        related to the patient's relative risk factors, duplex US,and physical examination and
        investigations. the operative details and data related to the post management follow up. this
        will be done under close supervision of my supervisors at the department of Vascular &
        EndovascularSurgery, Assiut University Hospitals
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 6 Years
  maximum age: 18 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Egypt
  url: http://www.usrds.org/2019/download/USRDS_2019_ES_final.pdf,Accessed09June2020
  description: Related Info
  responsible party type: Sponsor-Investigator
  investigator affiliation: Assiut University
  investigator full name: Alaa Gameil Abd El-salam Hussien
  investigator title: : Alaa Gameil Abd El-salam Hussien