Renal Safety of Bowel Preparation With Polyethylene Glycol

NCT02657564 | Completed Results DMC

• 1 other identifier: ZEH-2016-1
• Study Type: interventional
• Target: 1,237
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Participants With Acute Electrolyte Disturbance (Including Serum Caclium, Phosphate, Sodium, Potassium, Chloride, and Magnesium).

  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.

Study Arms (1)

Polyethylene glycol (PEG)

OTHER

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)

Interventions

Polyethylene glycol (PEG) DRUG

Participants receive blood tests for serum creatinine and electrolytes (Ca, P, Cl, Mg, Na, K) before and after taking polythylene glycol.

Also known as: Klean-Prep

Polyethylene glycol (PEG)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects 40 yrs of age or older scheduled for elective colonoscopy.

You may not qualify if:

• 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
• % of colon removed
• Idiopathic pseudo-obstruction

Sponsors & Collaborators

• Evergreen General Hospital, Taiwan: lead

Study Sites (1)

Evergreen General Hospital

Taoyuan District, 320, Taiwan

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Polyethylene Glycols; klean prep

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Dr. Chiliang Cheng
• Organization: Evergreen General Hospital

chiliang.cheng@gmail.com

+886-3-4631230

Study Officials

• Chiliang Cheng, MD

  Zhongli Evergreen General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 17, 2015
• First Posted: January 18, 2016
• Study Start: January 1, 2016
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: February 5, 2019
• Results First Posted: February 5, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)