Hyponatremia Due to Poly Ethylene Glycol (PEG)

Hyponatremia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03787888
• Other study ID #: DUHS
• Status: Completed
• Start date: March 1, 2019
• Est. completion date: September 30, 2019

Study information

• Verified date: December 2018
• Source: Dow University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: September 30, 2019
• Est. primary completion date: August 31, 2019
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Hyponatremia

Locations

Country	Name	City	State
Pakistan	Ruth KM Pauf Civil Hospital	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Tazeen Rasheed

Country where clinical trial is conducted

Pakistan, 

References & 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. — View 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. pii: 16-0119. doi: 10.1530/EDM-16-0119. eCollection 2017. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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