Hyponatremia Due to Poly Ethylene Glycol (PEG)

Sponsor

Tazeen Rasheed (Other)

Overall Status

Completed

CT.gov ID

NCT03787888

Collaborator

(none)

151

Enrollment

Location

Actual Duration (Months)

21.6

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Actual 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

Actual Study Start Date :

Mar 1, 2019

Actual Primary Completion Date :

Aug 31, 2019

Actual Study Completion Date :

Sep 30, 2019

Outcome Measures

Primary Outcome Measures

Frequency of hyponatremia caused by polyethelene glycol. [12 hours]
Frequency of hyponatremia caused by polyethelene glycol when used as a bowel cleansing agent for colonoscopy.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

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.

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ruth KM Pauf Civil Hospital	Karachi	Sindh	Pakistan	74000

Sponsors and Collaborators

Tazeen Rasheed

Investigators

Principal Investigator: Haris Alvi, FCPS, Dow University of Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Tazeen Rasheed, Assistant Professor, Dow University of Health Sciences

ClinicalTrials.gov Identifier:

NCT03787888

Other Study ID Numbers:

DUHS

First Posted:

Dec 26, 2018

Last Update Posted:

Aug 18, 2021

Last Verified:

Dec 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hyponatremia

Study Results

No Results Posted as of Aug 18, 2021