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Hyponatremia Due to Poly Ethylene Glycol (PEG)

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ClinicalTrials.gov Identifier: NCT03787888
Recruitment Status : Not yet recruiting
First Posted : December 25, 2018
Last Update Posted : December 25, 2018
Sponsor:
Information provided by (Responsible Party):
Tazeen Rasheed, Dow University of Health Sciences

Brief Summary:
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.

Condition or disease
Hyponatremia

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 151 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Frequency of Hyponatremia Caused by Polyethylene Glycol Solution When Used as a Bowel Cleansing Agent for Colonoscopy
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy




Primary Outcome Measures :
  1. Frequency of hyponatremia caused by polyethelene glycol. [ Time Frame: 12 hours ]
    Frequency of hyponatremia caused by polyethelene glycol when used as a bowel cleansing agent for colonoscopy.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing colonoscopy at OT complex Dr. K.M. Pfau, Civil Hospital Karachi.
Criteria

Inclusion Criteria:

  1. Patients of either gender of age between 18-80 years undergoing colonoscopy.
  2. Patients should have normal electrolytes before taking solution.
  3. Patients should have given informed consent.
  4. Patients should have taken solution adequately before procedure.

Exclusion Criteria:

  1. Patients with chronic kidney disease
  2. Patients on diuretics
  3. Patients who are hyponatremic on first sample, i.e., before taking bowel cleansing agent.
  4. Hypothyroidism

    -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03787888


Contacts
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Contact: Tazeen Rasheed, FCPS 0332-3826761 tazeen_hafeez@hotmail.co.uk
Contact: Bader F. Zuberi, FCPS 0308-4448862 bader@zuberi.net

Locations
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Pakistan
Ruth KM Pauf Civil Hospital
Karachi, Sindh, Pakistan, 74000
Sponsors and Collaborators
Tazeen Rasheed
Investigators
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Principal Investigator: Haris Alvi, FCPS Dow University of Health Sciences

Publications:
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Responsible Party: Tazeen Rasheed, Assistant Professor, Dow University of Health Sciences
ClinicalTrials.gov Identifier: NCT03787888     History of Changes
Other Study ID Numbers: DUHS
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hyponatremia
Water-Electrolyte Imbalance
Metabolic Diseases