Hyponatremia Due to Poly Ethylene Glycol (PEG)
Frequency of Hyponatremia Caused by Polyethylene Glycol Solution When Used as a Bowel Cleansing Agent for Colonoscopy
1 other identifier
observational
151
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2018
CompletedFirst Posted
Study publicly available on registry
December 26, 2018
CompletedStudy Start
First participant enrolled
March 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2019
CompletedAugust 18, 2021
December 1, 2018
6 months
December 15, 2018
August 17, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Frequency of hyponatremia caused by polyethelene glycol.
Frequency of hyponatremia caused by polyethelene glycol when used as a bowel cleansing agent for colonoscopy.
12 hours
Eligibility Criteria
Patients undergoing colonoscopy at OT complex Dr. K.M. Pfau, Civil Hospital Karachi.
You may qualify if:
- Patients of either gender of age between 18-80 years undergoing colonoscopy.
- Patients should have normal electrolytes before taking solution.
- Patients should have given informed consent.
- Patients should have taken solution adequately before procedure.
You may not qualify if:
- Patients with chronic kidney disease
- Patients on diuretics
- Patients who are hyponatremic on first sample, i.e., before taking bowel cleansing agent.
- Hypothyroidism
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tazeen Rasheedlead
Study Sites (1)
Ruth KM Pauf Civil Hospital
Karachi, Sindh, 74000, Pakistan
Related Publications (2)
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: 19481646BACKGROUNDSamad 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: 28458891BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Haris Alvi, FCPS
Dow University of Health Sciences
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
December 15, 2018
First Posted
December 26, 2018
Study Start
March 1, 2019
Primary Completion
August 31, 2019
Study Completion
September 30, 2019
Last Updated
August 18, 2021
Record last verified: 2018-12