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Completed

NCT Number: NCT02657564

Renal Safety of Bowel Preparation With Polyethylene Glycol

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

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Evergreen General Hospital

Taoyuan, 320, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Klean-Prep

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Evergreen General Hospital, Taiwan

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 18, 2016
Registry last updated
Feb 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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