<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/NCT03787888</url>
  </required_header>
  <id_info>
    <org_study_id>DUHS</org_study_id>
    <nct_id>NCT03787888</nct_id>
  </id_info>
  <brief_title>Hyponatremia Due to Poly Ethylene Glycol (PEG)</brief_title>
  <official_title>Frequency of Hyponatremia Caused by Polyethylene Glycol Solution When Used as a Bowel Cleansing Agent for Colonoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tazeen Rasheed</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dow University of Health Sciences</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>
      Colonoscopy is a useful tool used in modern medicine and it is increasingly being employed&#xD;
      for both diagnostic and therapeutic purposes. (Polyethelene glycol)PEG is very often used for&#xD;
      bowel preparation.There are some cases of hyponatremia reported due to the use of PEG. This&#xD;
      study was designed to find frequency of sodium disorders after bowel cleansing by&#xD;
      Polyethylene glycol solution for colonoscopies in Dr. Ruth K.M. Pfau, Civil Hospital Karachi.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Colonoscopy is a useful tool used in modern medicine and it is increasingly being employed&#xD;
      for both diagnostic and therapeutic purposes. PEG is very often used for bowel preparation.&#xD;
      PEG solutions clean the bowel with less water and electrolyte shifts, primarily by causing&#xD;
      mechanical effect of large-volume lavage 1. However, there are some cases of hyponatremia&#xD;
      reported due to the use of PEG. Life-threatening fluid and electrolyte disturbances are more&#xD;
      likely to occur in patients with risk factors, such as old age, use of SSRIs and thiazide&#xD;
      diuretics, chronic kidney disease, congestive heart failure or with a history of electrolyte&#xD;
      abnormalities 2.&#xD;
&#xD;
      Although sporadic case reports of hyponatremia and other electrolyte imbalances after bowel&#xD;
      preparation have been reported, but well-designed studies are lacking on this subject.&#xD;
      Literature search did not reveal any local studies on this subject. This study was designed&#xD;
      to find frequency of sodium disorders after bowel cleansing by Polyethylene glycol solution&#xD;
      for colonoscopies in Dr. Ruth K.M. Pfau, Civil Hospital Karachi.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Actual">September 30, 2019</completion_date>
  <primary_completion_date type="Actual">August 31, 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>Frequency of hyponatremia caused by polyethelene glycol.</measure>
    <time_frame>12 hours</time_frame>
    <description>Frequency of hyponatremia caused by polyethelene glycol when used as a bowel cleansing agent for colonoscopy.</description>
  </primary_outcome>
  <enrollment type="Actual">151</enrollment>
  <condition>Hyponatremia</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing colonoscopy at OT complex Dr. K.M. Pfau, Civil Hospital Karachi.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients of either gender of age between 18-80 years undergoing colonoscopy.&#xD;
&#xD;
          2. Patients should have normal electrolytes before taking solution.&#xD;
&#xD;
          3. Patients should have given informed consent.&#xD;
&#xD;
          4. Patients should have taken solution adequately before procedure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with chronic kidney disease&#xD;
&#xD;
          2. Patients on diuretics&#xD;
&#xD;
          3. Patients who are hyponatremic on first sample, i.e., before taking bowel cleansing&#xD;
             agent.&#xD;
&#xD;
          4. Hypothyroidism&#xD;
&#xD;
             -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Haris Alvi, FCPS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dow University of Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ruth KM Pauf Civil Hospital</name>
      <address>
        <city>Karachi</city>
        <state>Sindh</state>
        <zip>74000</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <reference>
    <citation>ASGE Technology Committee; Mamula P, Adler DG, Conway JD, Diehl DL, Farraye FA, Kantsevoy SV, Kaul V, Kethu SR, Kwon RS, Rodriguez SA, Tierney WM. Colonoscopy preparation. Gastrointest Endosc. 2009 Jun;69(7):1201-9. doi: 10.1016/j.gie.2009.01.035. No abstract available.</citation>
    <PMID>19481646</PMID>
  </reference>
  <reference>
    <citation>Samad N, Fraser I. Severe symptomatic hyponatremia associated with the use of polyethylene glycol-based bowel preparation. Endocrinol Diabetes Metab Case Rep. 2017 Feb 23;2017:16-0119. doi: 10.1530/EDM-16-0119. eCollection 2017.</citation>
    <PMID>28458891</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 15, 2018</study_first_submitted>
  <study_first_submitted_qc>December 22, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>August 17, 2021</last_update_submitted>
  <last_update_submitted_qc>August 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Dow University of Health Sciences</investigator_affiliation>
    <investigator_full_name>Tazeen Rasheed</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyponatremia</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/NCT03787888
org study id: DUHS
nct id: NCT03787888
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Colonoscopy is a useful tool used in modern medicine and it is increasingly being employed
      for both diagnostic and therapeutic purposes. (Polyethelene glycol)PEG is very often used for
      bowel preparation.There are some cases of hyponatremia reported due to the use of PEG. This
      study was designed to find frequency of sodium disorders after bowel cleansing by
      Polyethylene glycol solution for colonoscopies in Dr. Ruth K.M. Pfau, Civil Hospital Karachi.
Colonoscopy is a useful tool used in modern medicine and it is increasingly being employed
      for both diagnostic and therapeutic purposes. PEG is very often used for bowel preparation.
      PEG solutions clean the bowel with less water and electrolyte shifts, primarily by causing
      mechanical effect of large-volume lavage 1. However, there are some cases of hyponatremia
      reported due to the use of PEG. Life-threatening fluid and electrolyte disturbances are more
      likely to occur in patients with risk factors, such as old age, use of SSRIs and thiazide
      diuretics, chronic kidney disease, congestive heart failure or with a history of electrolyte
      abnormalities 2.

      Although sporadic case reports of hyponatremia and other electrolyte imbalances after bowel
      preparation have been reported, but well-designed studies are lacking on this subject.
      Literature search did not reveal any local studies on this subject. This study was designed
      to find frequency of sodium disorders after bowel cleansing by Polyethylene glycol solution
      for colonoscopies in Dr. Ruth K.M. Pfau, Civil Hospital Karachi.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Frequency of hyponatremia caused by polyethelene glycol.
time frame: 12 hours
description: Frequency of hyponatremia caused by polyethelene glycol when used as a bowel cleansing agent for colonoscopy.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
last name: Haris Alvi, FCPS
role: Principal Investigator
affiliation: Dow University of Health Sciences
facility: 
country: Pakistan
citation: ASGE Technology Committee; Mamula P, Adler DG, Conway JD, Diehl DL, Farraye FA, Kantsevoy SV, Kaul V, Kethu SR, Kwon RS, Rodriguez SA, Tierney WM. Colonoscopy preparation. Gastrointest Endosc. 2009 Jun;69(7):1201-9. doi: 10.1016/j.gie.2009.01.035. No abstract available.
PMID: 19481646
citation: Samad N, Fraser I. Severe symptomatic hyponatremia associated with the use of polyethylene glycol-based bowel preparation. Endocrinol Diabetes Metab Case Rep. 2017 Feb 23;2017:16-0119. doi: 10.1530/EDM-16-0119. eCollection 2017.
PMID: 28458891
responsible party type: Sponsor-Investigator
investigator affiliation: Dow University of Health Sciences
investigator full name: Tazeen Rasheed
investigator title: Assistant Professor
mesh term: Hyponatremia