<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/NCT03268460</url>
  </required_header>
  <id_info>
    <org_study_id>RTA in childern</org_study_id>
    <nct_id>NCT03268460</nct_id>
  </id_info>
  <brief_title>Incidence of Renal Tubular Acidosis in Nephrology Unit in Assiut University Childern Hospital</brief_title>
  <official_title>Incidence of Renal Tubular Acidosis in Nephrology Unit in Assiut University Childern Hospital (AUCH)</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>
      Providing summarized information on the clinical and biochemical characteristics and types of&#xD;
      renal tubular acidosis in children in Assiut University Childern Hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The term renal tubular acidosis (RTA) is applied to a group of transport defects in the&#xD;
      reabsorption of bicarbonate (HCO3_), the excretion of hydrogen ion (H_), or both. This&#xD;
      condition was first described in 1935, confirmed as a renal tubular disorder in 1946, and&#xD;
      designated &quot;renal tubular acidosis&quot; in 1951. The RTA syndromes are characterized by a&#xD;
      relatively normal GFR and a metabolic acidosis accompanied by hyperchloremia and a normal&#xD;
      plasma anion gap.&#xD;
&#xD;
      RTA is classified into 4 major forms: distal, proximal, hyperkalemic and combined RTA. Distal&#xD;
      RTA is associated with reduced urinary acid secretion, proximal RTA ( pRTA ) is characterized&#xD;
      by impaired bicarbonate (HCO3_) reabsorption, hyperkalemic RTA is an acid-base disturbance&#xD;
      generated by aldosterone deficiency or resistance and combined RTA is due to carbonic&#xD;
      anhydrase II deficiency. Electrolyte and acid-base disturbances are key components of each&#xD;
      disorder .&#xD;
&#xD;
      Patients with pRTA present with growth failure in the 1st yr of life. Additional symptoms can&#xD;
      include polyuria, dehydration (from sodium loss), anorexia, vomiting, constipation, and&#xD;
      hypotonia. Patients with primary Fanconi syndrome have additional symptoms, secondary to&#xD;
      phosphate wasting, such as rickets. Hypokalemia and related symptoms are also restricted to&#xD;
      cases with the Fanconi syndrome.&#xD;
&#xD;
      Distal RTA shares features with those of pRTA, including non-anion gap metabolic acidosis and&#xD;
      growth failure; distinguishing features of distal RTA include nephrocalcinosis and&#xD;
      hypercalciuria Combined proximal and distal RTA is a type observed as the result of inherited&#xD;
      carbonic anhydrase II deficiency in different organs and systems.&#xD;
&#xD;
      Patients with type IV RTA can present with growth failure in the first few years of life.&#xD;
      Polyuria and dehydration (from salt wasting) are common. Laboratory tests reveal a&#xD;
      hyperkalemic non-anion gap metabolic acidosis. Urine may be alkaline or acidic. Elevated&#xD;
      urinary sodium levels with inappropriately low urinary potassium levels reflect the absence&#xD;
      of aldosterone effect .&#xD;
&#xD;
      The first step in the evaluation of a patient with suspected RTA is to confirm the presence&#xD;
      of a normal anion gap metabolic acidosis, identify electrolyte abnormalities, assess renal&#xD;
      function, and rule out other causes of bicarbonate loss such as diarrhea .&#xD;
&#xD;
      The mainstay of therapy in all forms of RTA is bicarbonate replacement. Patients with pRTA&#xD;
      often require large quantities of bicarbonate, up to 20 mEq/kg/24 hr. The base requirement&#xD;
      for distal RTAs is generally in the range of 2-4 mEq/kg/24 hr, although patients'&#xD;
      requirements can vary. Patients with type IV RTA can require chronic treatment for&#xD;
      hyperkalemia with sodium potassium exchange resin .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 2018</start_date>
  <completion_date type="Anticipated">January 2019</completion_date>
  <primary_completion_date type="Anticipated">January 2019</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>percentage of cases with newly diagnosed renal tubular acidosis</measure>
    <time_frame>Baseline</time_frame>
    <description>percentage of cases presented by metabolic acidosis , failure to thrive and polyuria and diagnosed as RTA by arterial blood gases, blood anion gap, serum electrolytes, kidney function tests and urine analysis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>percentage of cases with each type of RTA</measure>
    <time_frame>Baseline</time_frame>
    <description>this is by measurement of serum K+ and urine PH. normal or low level of serum K+ with urine PH &lt; 5,5 with proximal RTA, while normal or low level of serum K+ with urine PH &gt; 5,5 with distal RTA. high level of serum K+ with urine PH &lt; 5,5 with hyperkalemic type 4 RTA, while high level of serum K+ with urine PH &gt; 5,5 with voltage defect distal RTA</description>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Renal Tubule Acidosis</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Arterial blood gases</intervention_name>
    <description>blood PH, HCO3</description>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Blood anion gap</intervention_name>
    <description>(Na+) - (Cl- + HCO3-)</description>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>serum electrolytes</intervention_name>
    <description>Na+ , K+ , Cl- and calcium</description>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>renal function test</intervention_name>
    <description>blood urea and serum creatinine</description>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>urine analysis</intervention_name>
    <description>urine PH, specific gravity, aminoaciduria, glycosuria, phospaturia and 24 hr urine calcium</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        • All cases presented with hypokalemia and normal anion gap hyperchloremic metabolic&#xD;
        acidosis with a relatively normal glomerular filteration rate.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age : From 1 year to 18 year.&#xD;
&#xD;
          -  Sex : Both sex male and female.&#xD;
&#xD;
          -  All cases presented with hypokalemia and normal anion gap hyperchloremic metabolic&#xD;
             acidosis with a relatively normal glomerular filteration rate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute diarrhea .&#xD;
&#xD;
          -  Urinary diversions.&#xD;
&#xD;
          -  Post hypocapnia.&#xD;
&#xD;
          -  Postobstructive diuresis.&#xD;
&#xD;
          -  Interstitial nephritis.&#xD;
&#xD;
          -  Active urinary tract infection.&#xD;
&#xD;
          -  Intake of medications interfere with urinary acidification.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Sally Ezzat</last_name>
    <phone>01001349860</phone>
    <phone_ext>00+20</phone_ext>
    <email>sallyezzat1992@gmail.com</email>
  </overall_contact>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>August 30, 2017</last_update_submitted>
  <last_update_submitted_qc>August 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Sally Ezzat Shafik mikhail</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>Acidosis, Renal Tubular</mesh_term>
    <mesh_term>Acidosis</mesh_term>
  </condition_browse>
  <!-- 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/NCT03268460
org study id: RTA in childern
nct id: NCT03268460
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Providing summarized information on the clinical and biochemical characteristics and types of
      renal tubular acidosis in children in Assiut University Childern Hospital.
The term renal tubular acidosis (RTA) is applied to a group of transport defects in the
      reabsorption of bicarbonate (HCO3_), the excretion of hydrogen ion (H_), or both. This
      condition was first described in 1935, confirmed as a renal tubular disorder in 1946, and
      designated "renal tubular acidosis" in 1951. The RTA syndromes are characterized by a
      relatively normal GFR and a metabolic acidosis accompanied by hyperchloremia and a normal
      plasma anion gap.

      RTA is classified into 4 major forms: distal, proximal, hyperkalemic and combined RTA. Distal
      RTA is associated with reduced urinary acid secretion, proximal RTA ( pRTA ) is characterized
      by impaired bicarbonate (HCO3_) reabsorption, hyperkalemic RTA is an acid-base disturbance
      generated by aldosterone deficiency or resistance and combined RTA is due to carbonic
      anhydrase II deficiency. Electrolyte and acid-base disturbances are key components of each
      disorder .

      Patients with pRTA present with growth failure in the 1st yr of life. Additional symptoms can
      include polyuria, dehydration (from sodium loss), anorexia, vomiting, constipation, and
      hypotonia. Patients with primary Fanconi syndrome have additional symptoms, secondary to
      phosphate wasting, such as rickets. Hypokalemia and related symptoms are also restricted to
      cases with the Fanconi syndrome.

      Distal RTA shares features with those of pRTA, including non-anion gap metabolic acidosis and
      growth failure; distinguishing features of distal RTA include nephrocalcinosis and
      hypercalciuria Combined proximal and distal RTA is a type observed as the result of inherited
      carbonic anhydrase II deficiency in different organs and systems.

      Patients with type IV RTA can present with growth failure in the first few years of life.
      Polyuria and dehydration (from salt wasting) are common. Laboratory tests reveal a
      hyperkalemic non-anion gap metabolic acidosis. Urine may be alkaline or acidic. Elevated
      urinary sodium levels with inappropriately low urinary potassium levels reflect the absence
      of aldosterone effect .

      The first step in the evaluation of a patient with suspected RTA is to confirm the presence
      of a normal anion gap metabolic acidosis, identify electrolyte abnormalities, assess renal
      function, and rule out other causes of bicarbonate loss such as diarrhea .

      The mainstay of therapy in all forms of RTA is bicarbonate replacement. Patients with pRTA
      often require large quantities of bicarbonate, up to 20 mEq/kg/24 hr. The base requirement
      for distal RTAs is generally in the range of 2-4 mEq/kg/24 hr, although patients'
      requirements can vary. Patients with type IV RTA can require chronic treatment for
      hyperkalemia with sodium potassium exchange resin .
observational model: Case-Only
time perspective: Cross-Sectional
measure: percentage of cases with newly diagnosed renal tubular acidosis
time frame: Baseline
description: percentage of cases presented by metabolic acidosis , failure to thrive and polyuria and diagnosed as RTA by arterial blood gases, blood anion gap, serum electrolytes, kidney function tests and urine analysis.
measure: percentage of cases with each type of RTA
time frame: Baseline
description: this is by measurement of serum K+ and urine PH. normal or low level of serum K+ with urine PH < 5,5 with proximal RTA, while normal or low level of serum K+ with urine PH > 5,5 with distal RTA. high level of serum K+ with urine PH < 5,5 with hyperkalemic type 4 RTA, while high level of serum K+ with urine PH > 5,5 with voltage defect distal RTA
intervention type: Diagnostic Test
intervention name: Arterial blood gases
description: blood PH, HCO3
intervention type: Diagnostic Test
intervention name: Blood anion gap
description: (Na+) - (Cl- + HCO3-)
intervention type: Diagnostic Test
intervention name: serum electrolytes
description: Na+ , K+ , Cl- and calcium
intervention type: Diagnostic Test
intervention name: renal function test
description: blood urea and serum creatinine
intervention type: Diagnostic Test
intervention name: urine analysis
description: urine PH, specific gravity, aminoaciduria, glycosuria, phospaturia and 24 hr urine calcium
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Year
maximum age: 18 Years
healthy volunteers: No
last name: Sally Ezzat
phone: 01001349860
phone ext: 00+20
email: sallyezzat1992@gmail.com
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Sally Ezzat Shafik mikhail
investigator title: principal investigator
mesh term: Acidosis, Renal Tubular
mesh term: Acidosis