Acute Kidney Injury
Conditions
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.
Interventions
Participants receive blood tests for serum creatinine and electrolytes (Ca, P, Cl, Mg, Na, K) before and after taking polythylene glycol.
Sponsors
Evergreen General Hospital, Taiwan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Acute Renal Injury Which Included Acute Renal Dysfunction and Acute Kidney Injury | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Polyethylene Glycol (PEG) 3L polyethylene glycol (PEG) is provided for colonoscopy preparation. Patients receive blood tests for renal function and electrolytes before and after colonoscopy.
3L Polyethylene glycol (PEG): Participants receive blood tests for serum creatinine and electrolytes (Ca, P, Cl, Mg, Na, K) before and after taking polythylene glycol. | 1,163 |
| Total | 1,163 |
Baseline characteristics
| Characteristic | Polyethylene Glycol (PEG) | — |
|---|---|---|
| Age, Continuous | 55.7 years STANDARD_DEVIATION 9.4 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 623 Participants | — |
| Sex: Female, Male Male | 540 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1,163 |
| other Total, other adverse events | 350 / 1,163 |
| serious Total, serious adverse events | 0 / 1,163 |
Outcome results
Primary
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.
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Polyethylene Glycol (PEG) | Number of Participants With Acute Renal Injury Which Included Acute Renal Dysfunction and Acute Kidney Injury | 32 participants |
Secondary
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.
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Polyethylene Glycol (PEG) | Number of Participants With Acute Electrolyte Disturbance (Including Serum Caclium, Phosphate, Sodium, Potassium, Chloride, and Magnesium). | 447 Participants |