Renal Safety of Bowel Preparation With Polyethylene Glycol

Evergreen General Hospital, Taiwan

Status: Completed

Conditions: Acute Kidney Injury

Treatments: Drug: Polyethylene glycol (PEG)

Study type: Interventional

Funder types: Other

Identifiers

NCT02657564

ZEH-2016-1

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,237 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

1,237 participants in 1 patient group

Polyethylene glycol (PEG)

Other group

Description:

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

Treatment:

Drug: Polyethylene glycol (PEG)