Completed

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

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Over 18 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: July 2010
See protocol details

Summary

Principal SponsorKlinik Bogenhausen
Last updated: February 26, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2010

Actual date on which the first participant was enrolled.

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.

Principal SponsorKlinik Bogenhausen
Last updated: February 26, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

190 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate
=18 years

indication for colonoscopy

4 exclusion criteria prevent from participating
18 years

acute inflammatory bowel disease

high-grade cardiac or renal insufficiency

previous bowel resection

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Klinikum Bogenhausen - Klinikum München GmbH

Munich, GermanyOpen Klinikum Bogenhausen - Klinikum München GmbH in Google Maps
CompletedOne Study Center