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Renal Safety of Bowel Preparation With Polyethylene Glycol

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ClinicalTrials.gov Identifier: NCT02657564
Recruitment Status : Completed
First Posted : January 18, 2016
Results First Posted : February 5, 2019
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Chi-Liang Cheng, Evergreen General Hospital, Taiwan

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

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Drug: Polyethylene glycol (PEG) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1237 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The Renal Safety of Bowel Preparation With Polyethylene Glycol for Colonoscopy: A Prospective Cohort Study
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Polyethylene glycol (PEG)
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)
Participants receive blood tests for serum creatinine and electrolytes (Ca, P, Cl, Mg, Na, K) before and after taking polythylene glycol.
Other Name: Klean-Prep




Primary Outcome Measures :
  1. Number of Participants With Acute Renal Injury Which Included Acute Renal Dysfunction and Acute Kidney Injury [ 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. ]
    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 :
  1. Number of Participants With Acute Electrolyte Disturbance (Including Serum Caclium, Phosphate, Sodium, Potassium, Chloride, and Magnesium). [ 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. ]
    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.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657564


Locations
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Taiwan
Evergreen General Hospital
Taoyuan, Taiwan, 320
Sponsors and Collaborators
Evergreen General Hospital, Taiwan
Investigators
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Principal Investigator: Chiliang Cheng, MD Zhongli Evergreen General Hospital, Taiwan
  Study Documents (Full-Text)

Documents provided by Chi-Liang Cheng, Evergreen General Hospital, Taiwan:
Study Protocol  [PDF] November 18, 2015
Statistical Analysis Plan  [PDF] November 18, 2015


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Responsible Party: Chi-Liang Cheng, Assistant Professor, Evergreen General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT02657564     History of Changes
Other Study ID Numbers: ZEH-2016-1
First Posted: January 18, 2016    Key Record Dates
Results First Posted: February 5, 2019
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases