Clinical trial NCT03787888: Hyponatremia Due to Poly Ethylene Glycol (PEG)
Official title: Frequency of Hyponatremia Caused by Polyethylene Glycol Solution When Used as a Bowel Cleansing Agent for Colonoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyponatremia
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2018-12-26
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing colonoscopy at OT complex Dr. K.M. Pfau, Civil Hospital Karachi.

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.

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.

Eligibility 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

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Primary outcomes:
measure: Frequency of hyponatremia caused by polyethelene glycol.
timeFrame: 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Ruth KM Pauf Civil Hospital
state: Sindh
Study officials:
affiliation: Dow University of Health Sciences
name: Haris Alvi, FCPS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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;2017:16-0119. doi: 10.1530/EDM-16-0119. eCollection 2017.