N/A Completed N=1,237 Health Services Research

Renal Safety of Bowel Preparation With Polyethylene Glycol

Chronic Kidney Disease

Source: ClinicalTrials.gov NCT02657564 ↗

Enrolled (actual)

1,237

Serious AEs

0.0%

Results posted

Feb 2019

Primary outcomePrimary: Number of Participants With Acute Renal Injury Which Included Acute Renal Dysfunction and Acute Kidney Injury — 32 participants

Summary

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Acute Renal Injury Which Included Acute Renal Dysfunction and Acute Kidney Injury	32	—
SECONDARY Number of Participants With Acute Electrolyte Disturbance (Including Serum Caclium, Phosphate, Sodium, Potassium, Chloride, and Magnesium).	447	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02657564). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.