Hyponatremia Due to Poly Ethylene Glycol (PEG)

Frequency of Hyponatremia Caused by Polyethylene Glycol Solution When Used as a Bowel Cleansing Agent for Colonoscopy

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.

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 151

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74000
      • Ruth KM Pauf Civil Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing colonoscopy at OT complex Dr. K.M. Pfau, Civil Hospital Karachi.

Description

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

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Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tazeen Rasheed
• Investigators: Principal Investigator: Haris Alvi, FCPS, Dow University of Health Sciences

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): August 31, 2019
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: December 15, 2018
• First Submitted That Met QC Criteria: December 22, 2018
• First Posted (Actual): December 26, 2018

Study Record Updates

• Last Update Posted (Actual): August 18, 2021
• Last Update Submitted That Met QC Criteria: August 17, 2021
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Water-Electrolyte Imbalance; Hyponatremia
• Other Study ID Numbers: DUHS (Other Identifier: DUHS)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No