N/A
N=1,237
Renal Safety of Bowel Preparation With Polyethylene Glycol
Acute Kidney Injury
Bottom Line
View on ClinicalTrials.gov: NCT02657564 ↗Enrolled (actual)
1,237
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Number of Participants With Acute Renal Injury Which Included Acute Renal Dysfunction and Acute Kidney Injury — 32 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Polyethylene glycol (PEG) (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Evergreen General Hospital, Taiwan
- Primary completion
- Jun 2017
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 | — |
Summary
This study evaluates the changes of renal function after taking bowel cleansing agent polyethylene glycol for elective colonoscopy.
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
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.