Renal Safety of Bowel Preparation With Polyethylene Glycol

Study Overview
=================
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.

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

Conditions
-----------------
Acute Kidney Injury

Intervention / Treatment
-----------------
* Drug: Polyethylene glycol (PEG)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Polyethylene glycol (PEG)<br>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)<br>* Participants receive blood tests for serum creatinine and electrolytes (Ca, P, Cl, Mg, Na, K) before and after taking polythylene glycol.<br>* 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. |