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Clinical Trials/NCT01841138
NCT01841138CompletedNot Applicable

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

Klinik Bogenhausen1 site in 1 country190 target enrollmentStarted: July 2010Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
190
Locations
1
Primary Endpoint
Proportion of patients with serum sodium concentration beyond the limits of normal after the completion of bowel preparation

Study Overview

Brief 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • indication for colonoscopy
  • >=18 years

Exclusion Criteria

  • <18 years
  • acute inflammatory bowel disease
  • previous bowel resection
  • high-grade cardiac or renal insufficiency

Outcomes

Primary Outcomes

Proportion of patients with serum sodium concentration beyond the limits of normal after the completion of bowel preparation

Time Frame: within 2 hours before the beginning of colonoscopy

Secondary Outcomes

  • 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)

Investigators

Sponsor
Klinik Bogenhausen
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Arne Schneider

PI

Klinik Bogenhausen

Study Sites (1)

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