Changes of Serum Electrolytes During Bowel Prep With PEG 3350 + Ascorbic Acid - a Prospective Study

Colonoscopy Clinical Trial

Official title:

Changes of Serum Electrolytes During Bowel Prep With PEG 3350 + Ascorbic Acid - a Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01841138
• Other study ID #: GastroKMBColEl
• Status: Completed
• Start date: July 2010
• Est. completion date: December 15, 2016

Study information

• Verified date: February 2019
• Source: Klinik Bogenhausen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Hypothesis: Patients who undergo bowel preparation with PEG 3350 + ascorbic acid may have significant changes of serum electrolytes.

A new PEG solution (Moviprep = PEG 3350 + ascorbic acid) for colonoscopy reduces the amount of cathartic solution to 2 liters, but requires drinking of additional liquid for optimal results. Ingestion of a high volume of free water bears a risk for severe changes of serum electrolytes, particularly for sodium and potassium.

In this trial, patients undergo regular bowel preparation for standard colonoscopy with Moviprep (2 liters Moviprep split-dose plus ≥2 liters of free liquid until sufficient cleansing is achieved). Blood samples for serum sodium, potassium, chloride, magnesium, phosphate, calcium and serum osmolarity are taken before the beginning of the prep procedure and right before colonoscopy. The interval between both blood samples that will be compared is roughly 24 hours. Additionally, the volume of prep solution and additional liquid is recorded. The quality of bowel preparation is visually rated during colonoscopy with a validated score.

Pre- and postpreparation serum parameters will be compared. Primary outcome measure is the proportion of patients who have a serum sodium beyond the reference values after the completion of bowel preparation. Secondary outcome parameters are the proportion of patients with other serum electrolytes or serum osmolarity beyond the reference. Moreover, changes of serum electrolytes and osmolarity will be correlated with the amount of prep solution and liquid.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: December 15, 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• indication for colonoscopy

• >=18 years

Exclusion Criteria:

• <18 years

• acute inflammatory bowel disease

• previous bowel resection

• high-grade cardiac or renal insufficiency

Related Conditions & MeSH terms

• Colonoscopy

Locations

Country	Name	City	State
Germany	Klinikum Bogenhausen - Klinikum München GmbH	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Klinik Bogenhausen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with serum sodium concentration beyond the limits of normal after the completion of bowel preparation		within 2 hours before the beginning of colonoscopy
Secondary	Proportion of patients with serum potassium or calcium or chloride or magnesium concentration beyond the limits of normal after the completion of bowel preparation		within 2 hours before the beginning of colonoscopy