Clinical trial NCT02657564: Renal Safety of Bowel Preparation With Polyethylene Glycol
Official title: The Renal Safety of Bowel Preparation With Polyethylene Glycol for Colonoscopy: A Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Injury
Lead sponsor: Evergreen General Hospital, Taiwan
Sponsor class: OTHER
First posted: 2016-01-18
Enrollment: 1237
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Number of Participants With Acute Renal Injury Which Included Acute Renal Dysfunction and Acute Kidney Injury
timeFrame: 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 outcomes:
measure: Number of Participants With Acute Electrolyte Disturbance (Including Serum Caclium, Phosphate, Sodium, Potassium, Chloride, and Magnesium).
timeFrame: 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.
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Evergreen General Hospital
Study officials:
affiliation: Zhongli Evergreen General Hospital, Taiwan
name: Chiliang Cheng, MD
role: PRINCIPAL_INVESTIGATOR
References: