Renal Safety of Bowel Preparation With Polyethylene Glycol

NCT ID: NCT02657564

Last Updated: 2019-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1237 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2017-06-30

Brief Summary

This study evaluates the changes of renal function after taking bowel cleansing agent polyethylene glycol for elective colonoscopy.

Detailed Description

Polyethylene glycol (PEG) is the most commonly used bowel cleansing agent for colonoscopy in the world.

PEGs are non-absorbable isosmotic solutions that pass through the bowel without net absorption or secretion. Significant fluid and electrolyte shifts are therefore attenuated.

However, several studies have shown that PEG may also impair renal function. One recent population-based study reported that the use of PEG was associated with an increased risk of acute kidney injury.

The renal safety of PEG in Taiwanese patient has not been reported.

Conditions

Acute Kidney Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Polyethylene glycol (PEG)

3-L polyethylene glycol (PEG) is provided for colonoscopy preparation. Patients receive blood tests for renal function and electrolytes before and after colonoscopy.

Group Type: OTHER

Polyethylene glycol (PEG)

Intervention Type: DRUG

Participants receive blood tests for serum creatinine and electrolytes (Ca, P, Cl, Mg, Na, K) before and after taking polythylene glycol.

Interventions

Polyethylene glycol (PEG)

Participants receive blood tests for serum creatinine and electrolytes (Ca, P, Cl, Mg, Na, K) before and after taking polythylene glycol.

Intervention Type: DRUG

Other Intervention Names

Klean-Prep

Eligibility Criteria

Inclusion Criteria

• Subjects 40 yrs of age or older scheduled for elective colonoscopy.

Exclusion Criteria

• Severely reduced kidney function (eGFR] <30 mL/min/1.73 m2)
• Serum electrolyte abnormalities at screening
• Uncontrolled congestive heart failure (American Heart Association Classification III or IV)
• Unstable angina
• Untreated dysrhythmia
• Myocardial infarction, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft surgery within the previous 3 months
• Ascites
• Current acute exacerbation of chronic inflammatory bowel disease
• Toxic colitis or toxic megacolon
• Ileus and/or acute obstruction or perforation
• Ileostomy
• Right or transverse colostomy
• Subtotal colectomy with ileosigmoidostomy

• 50% of colon removed
• Idiopathic pseudo-obstruction
• History of gastric stapling or bypass procedure
• Difficulties swallowing
• Treatment with an investigational drug or product
• Participation in a drug study within 30 days prior to receiving study medication
• Treatment with another bowel preparation within 21 days prior to colonoscopy
• Known allergy or hypersensitivity to PEG solution

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Evergreen General Hospital, Taiwan

OTHER

Sponsor Role: lead

Responsible Party

Chi-Liang Cheng

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chiliang Cheng, MD

Role: PRINCIPAL_INVESTIGATOR

Zhongli Evergreen General Hospital, Taiwan

Locations

Evergreen General Hospital

Taoyuan District, , Taiwan

Countries

Taiwan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ZEH-2016-1

Identifier Type: -

Identifier Source: org_study_id