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

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ClinicalTrials.gov Identifier: NCT01841138
Recruitment Status : Completed
First Posted : April 26, 2013
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Arne Schneider, Klinik Bogenhausen

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.


Condition or disease
Colonoscopy

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Study Type : Observational
Actual Enrollment : 190 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Changes of Serum Electrolytes During Bowel Prep With PEG 3350 + Ascorbic Acid - a Prospective Study
Study Start Date : July 2010
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 15, 2016

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Proportion of patients with serum potassium or calcium or chloride or magnesium concentration beyond the limits of normal after the completion of bowel preparation [ Time Frame: within 2 hours before the beginning of colonoscopy ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with an indicaton for colonoscopy
Criteria

Inclusion Criteria:

  • indication for colonoscopy
  • >=18 years

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01841138


Locations
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Germany
Klinikum Bogenhausen - Klinikum München GmbH
Munich, Germany, 81925
Sponsors and Collaborators
Klinik Bogenhausen

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Responsible Party: Arne Schneider, PI, Klinik Bogenhausen
ClinicalTrials.gov Identifier: NCT01841138     History of Changes
Other Study ID Numbers: GastroKMBColEl
First Posted: April 26, 2013    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Keywords provided by Arne Schneider, Klinik Bogenhausen:
colonoscopy
bowel preparation
electrolytes
osmolality
water
Additional relevant MeSH terms:
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Ascorbic Acid
Polyethylene glycol 3350
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Nutrients
Growth Substances
Laxatives
Gastrointestinal Agents