Hyponatremia Due to Poly Ethylene Glycol (PEG)

NCT ID: NCT03787888

Last Updated: 2021-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

151 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-01

Study Completion Date

2019-09-30

Brief Summary

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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

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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.

Conditions

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Hyponatremia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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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Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tazeen Rasheed

OTHER

Sponsor Role lead

Responsible Party

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Tazeen Rasheed

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Haris Alvi, FCPS

Role: PRINCIPAL_INVESTIGATOR

Dow University of Health Sciences

Locations

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Ruth KM Pauf Civil Hospital

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type BACKGROUND
PMID: 19481646 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28458891 (View on PubMed)

Other Identifiers

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DUHS

Identifier Type: -

Identifier Source: org_study_id

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