Back to resultsRenal Safety of Bowel Preparation With Polyethylene Glycol
Primary Purpose
Acute Kidney Injury
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Polyethylene glycol (PEG)
Sponsored by
About this trial
This is an interventional health services research trial for Acute Kidney Injury
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
Sites / Locations
- Evergreen General Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Polyethylene glycol (PEG)
Arm Description
3-L polyethylene glycol (PEG) is provided for colonoscopy preparation. Patients receive blood tests for renal function and electrolytes before and after colonoscopy.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02657564
First Posted
November 17, 2015
Last Updated
February 3, 2019
Sponsor
Evergreen General Hospital, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT02657564
Brief Title
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
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Evergreen General Hospital, Taiwan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1237 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Polyethylene glycol (PEG)
Arm Type
Other
Arm Description
3-L polyethylene glycol (PEG) is provided for colonoscopy preparation. Patients receive blood tests for renal function and electrolytes before and after colonoscopy.
Intervention Type
Drug
Intervention Name(s)
Polyethylene glycol (PEG)
Other Intervention Name(s)
Klean-Prep
Intervention Description
Participants receive blood tests for serum creatinine and electrolytes (Ca, P, Cl, Mg, Na, K) before and after taking polythylene glycol.
Primary Outcome Measure Information:
Title
Number of Participants With Acute Renal Injury Which Included Acute Renal Dysfunction and Acute Kidney Injury
Description
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.
Time Frame
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 Measure Information:
Title
Number of Participants With Acute Electrolyte Disturbance (Including Serum Caclium, Phosphate, Sodium, Potassium, Chloride, and Magnesium).
Description
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.
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chiliang Cheng, MD
Organizational Affiliation
Zhongli Evergreen General Hospital, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Evergreen General Hospital
City
Taoyuan
ZIP/Postal Code
320
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
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Renal Safety of Bowel Preparation With Polyethylene Glycol
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