<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/NCT03806088</url>
  </required_header>
  <id_info>
    <org_study_id>IslamiaUS</org_study_id>
    <nct_id>NCT03806088</nct_id>
  </id_info>
  <brief_title>Prevalence of Electrolyte Imbalance in Chronic Kidney Disease:A Study at Tertiary Care Hospital in South Punjab,Pakistan</brief_title>
  <official_title>Prevalence of Electrolyte Imbalance in Chronic Kidney Disease: A Study at Tertiary Care Hospitals in South Punjab, Pakistan</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Islamia University of Bahawalpur</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Islamia University of Bahawalpur</source>
  <oversight_info>
    <has_dmc>No</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>
      an observational cross-sectional study is done to calculate the electrolyte imbalance at&#xD;
      different stages of chronic kidney disease at tertiary care hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      an observational cross-sectional study is done to calculate the electrolyte imbalance at&#xD;
      different stages of chronic kidney disease at tertiary care hospitals of south Punjab,&#xD;
      Pakistan .The outcomes of chronic kidney disease and end stage of renal failure will be&#xD;
      calculated according to standard protocol. Under the supervision of pathologists,&#xD;
      pharmacologists, pharmacists, nephrologists, urologists and biostatistician. The standard&#xD;
      protocol was authorized by ethical committee of each center. patient consent form was&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Anticipated">November 25, 2019</completion_date>
  <primary_completion_date type="Actual">November 25, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>2 Months</target_duration>
  <primary_outcome>
    <measure>Serum potassium in mEq/L</measure>
    <time_frame>2days</time_frame>
    <description>Serum potassium in mEq/L by taking blood sample under standard condition</description>
  </primary_outcome>
  <primary_outcome>
    <measure>serum urea in mg/dl</measure>
    <time_frame>2days</time_frame>
    <description>serum urea in mg/dl by taking blood sample under standard condition</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum creatinine in mg/dl</measure>
    <time_frame>2days</time_frame>
    <description>Serum creatinine in mg/dl by taking blood sample under standard condition</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum calcium in mg/dl</measure>
    <time_frame>2days</time_frame>
    <description>Serum calcium in mg/dl by taking blood sample under standard condition</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum sodium in mEq/L</measure>
    <time_frame>2days</time_frame>
    <description>Serum sodium in mEq/L by taking blood sample under standard condition</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood pressure in mm of Hg</measure>
    <time_frame>2days</time_frame>
    <description>Blood pressure in mm of Hg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood glucose concentration in mg/dl</measure>
    <time_frame>2days</time_frame>
    <description>Blood glucose concentration in mg/dl random</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">385</enrollment>
  <condition>Chronic Kidney Diseases</condition>
  <arm_group>
    <arm_group_label>patients of chronic kidney disease</arm_group_label>
    <description>no interventions</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        An observational cross sectional study is done on pakistani population while working in&#xD;
        different tertiary care hospitals of south Punjab including Bahawal Victoria hospital&#xD;
        Bahawalpur, kidney center Multan and many registered clinics, under the supervision of&#xD;
        pathologists, pharmacologists,pharmacists,nephrologists,urologists and biostatistician.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  CKD patients ranging&#xD;
&#xD;
          -  age from 20-80&#xD;
&#xD;
          -  dialysis and pre-dialysis patients&#xD;
&#xD;
          -  who provide written consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  congenital one kidney patients&#xD;
&#xD;
          -  organ or kidney donors and transplantation&#xD;
&#xD;
          -  pregnant women&#xD;
&#xD;
          -  renal injury during trauma&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>H M Attaullah, pharm.D</last_name>
    <phone>03044229043</phone>
    <email>attaullah@inbox.eu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Faculty of Pharmacy and Alternative Medicine Khawaja Freed Campus</name>
      <address>
        <city>Bahāwalpur</city>
        <state>Punjab</state>
        <zip>63100</zip>
        <country>Pakistan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>attaullah</last_name>
      <phone>03044229043</phone>
      <email>attaullah@inbox.eu</email>
    </contact>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>January 13, 2019</study_first_submitted>
  <study_first_submitted_qc>January 13, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>November 25, 2019</last_update_submitted>
  <last_update_submitted_qc>November 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Islamia University of Bahawalpur</investigator_affiliation>
    <investigator_full_name>Hafiz Muhammad Attaullah</investigator_full_name>
    <investigator_title>HAFIZ MUHAMMAD ATTAULLAH student of pharm-D</investigator_title>
  </responsible_party>
  <keyword>CKD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</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/NCT03806088
org study id: IslamiaUS
nct id: NCT03806088
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
an observational cross-sectional study is done to calculate the electrolyte imbalance at
      different stages of chronic kidney disease at tertiary care hospital.
an observational cross-sectional study is done to calculate the electrolyte imbalance at
      different stages of chronic kidney disease at tertiary care hospitals of south Punjab,
      Pakistan .The outcomes of chronic kidney disease and end stage of renal failure will be
      calculated according to standard protocol. Under the supervision of pathologists,
      pharmacologists, pharmacists, nephrologists, urologists and biostatistician. The standard
      protocol was authorized by ethical committee of each center. patient consent form was
observational model: Other
time perspective: Prospective
measure: Serum potassium in mEq/L
time frame: 2days
description: Serum potassium in mEq/L by taking blood sample under standard condition
measure: serum urea in mg/dl
time frame: 2days
description: serum urea in mg/dl by taking blood sample under standard condition
measure: Serum creatinine in mg/dl
time frame: 2days
description: Serum creatinine in mg/dl by taking blood sample under standard condition
measure: Serum calcium in mg/dl
time frame: 2days
description: Serum calcium in mg/dl by taking blood sample under standard condition
measure: Serum sodium in mEq/L
time frame: 2days
description: Serum sodium in mEq/L by taking blood sample under standard condition
measure: Blood pressure in mm of Hg
time frame: 2days
description: Blood pressure in mm of Hg
measure: Blood glucose concentration in mg/dl
time frame: 2days
description: Blood glucose concentration in mg/dl random
arm group label: patients of chronic kidney disease
description: no interventions
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: H M Attaullah, pharm.D
phone: 03044229043
email: attaullah@inbox.eu
facility: 
status: Recruiting
contact: 
country: Pakistan
responsible party type: Principal Investigator
investigator affiliation: Islamia University of Bahawalpur
investigator full name: Hafiz Muhammad Attaullah
investigator title: HAFIZ MUHAMMAD ATTAULLAH student of pharm-D
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic