Renal Safety of Bowel Preparation With Polyethylene Glycol

The Renal Safety of Bowel Preparation With Polyethylene Glycol for Colonoscopy: A Prospective Cohort Study

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

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Drug: Polyethylene glycol (PEG)

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.

• Study Type: Interventional
• Enrollment (Actual): 1237
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 320
    • Evergreen General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Drug: Polyethylene glycol (PEG); Participants receive blood tests for serum creatinine and electrolytes (Ca, P, Cl, Mg, Na, K) before and after taking polythylene glycol.; Other Names: Klean-Prep

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Acute Renal Injury Which Included Acute Renal Dysfunction and Acute Kidney Injury	The screening visit (visit 1) induced a blood specimen for serum chemistry analysis. Immediately before the colonoscopy, study staff collected blood specimens for chemistry analysis (visit 2). The patients returned within 28 days after the colonoscopy for a final renal test (visit 3). Patients with a ≥30% increase above baseline creatinine levels during visit 2 or 3 were followed every 2-4 weeks until a peak level was detected (visit 4 and beyond).The serum creatinine level on visit 1 was recorded as the baseline renal function. The presence of renal injuries was determined by the highest serum creatinine level noted during the study period and included acute renal dysfunction, defined as a 30-49% increase above the baseline creatinine level, and acute kidney injury, defined as a ≥50% increase above the baseline serum creatinine. Number of participants with acute renal injury which included acute renal dysfunction and acute kidney injury will be recorded.	The durations between visits 1-2 and visits 2-3 were within 28 days, respectively. Patients with a ≥30% increase above the baseline serum creatinine levels during visit 2 or 3 were followed every 2-4 weeks until a peak level of creatinine was detected.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Acute Electrolyte Disturbance (Including Serum Caclium, Phosphate, Sodium, Potassium, Chloride, and Magnesium).	The screening visit (visit 1) induced a blood specimen for serum chemistry analysis. Immediately before the colonoscopy, study staff collected blood specimens for chemistry analysis (visit 2). The patients returned within 28 days after the colonoscopy for a final renal safety evaluation (visit 3). Patients with electrolyte abnormalities during visit 2 or visit 3 were followed every 2-4 weeks until serum electrolyte values returned to normal.	The durations between visits 1-2 and visits 2-3 were within 28 days, respectively. Patients with electrolyte abnormalities during visit 2 or visit 3 were followed every 2-4 weeks until serum electrolyte values returned to normal.

Collaborators and Investigators

• Sponsor: Evergreen General Hospital, Taiwan
• Investigators: Principal Investigator: Chiliang Cheng, MD, Zhongli Evergreen General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): June 30, 2017
• Study Completion (Actual): June 30, 2017

Study Registration Dates

• First Submitted: November 17, 2015
• First Submitted That Met QC Criteria: January 13, 2016
• First Posted (Estimate): January 18, 2016

Study Record Updates

• Last Update Posted (Actual): February 5, 2019
• Last Update Submitted That Met QC Criteria: February 3, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: ZEH-2016-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No