Trial Outcomes & Findings for Renal Safety of Bowel Preparation With Polyethylene Glycol (NCT NCT02657564)
NCT ID: NCT02657564
Last Updated: 2019-02-05
Results Overview
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.
COMPLETED
NA
1237 participants
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.
2019-02-05
Participant Flow
Participant milestones
| Measure |
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.
Polyethylene glycol (PEG): Participants receive blood tests for serum creatinine and electrolytes (Ca, P, Cl, Mg, Na, K) before and after taking polythylene glycol.
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Overall Study
STARTED
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1237
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Overall Study
COMPLETED
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1163
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Overall Study
NOT COMPLETED
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74
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Polyethylene Glycol (PEG)
n=1163 Participants
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.
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Age, Continuous
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55.7 years
STANDARD_DEVIATION 9.4 • n=1163 Participants
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Sex: Female, Male
Female
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623 Participants
n=1163 Participants
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Sex: Female, Male
Male
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540 Participants
n=1163 Participants
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Polyethylene Glycol (PEG)
n=1163 Participants
A total of 1,163 patients completed the study protocol in which 3-L polyethylene glycol was used as colonoscopy preparation.
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Number of Participants With Acute Renal Injury Which Included Acute Renal Dysfunction and Acute Kidney Injury
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32 participants
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Polyethylene Glycol (PEG)
n=1163 Participants
A total of 1,163 patients completed the study protocol in which 3-L polyethylene glycol was used as colonoscopy preparation.
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|---|---|
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Number of Participants With Acute Electrolyte Disturbance (Including Serum Caclium, Phosphate, Sodium, Potassium, Chloride, and Magnesium).
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447 Participants
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Adverse Events
Polyethylene Glycol (PEG)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Polyethylene Glycol (PEG)
n=1163 participants at risk
3-L polyethylene glycol (PEG) is provided for colonoscopy preparation. Patients receive blood tests for renal function and electrolytes before and after colonoscopy.
Polyethylene glycol (PEG): Participants receive blood tests for serum creatinine and electrolytes (Ca, P, Cl, Mg, Na, K) before and after taking polythylene glycol.
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General disorders
Any Electrolyte Abnormality
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30.1%
350/1163 • Number of events 350 • Colonoscopy related complication was observed during and within one month after colonoscopy. Patient with acute renal injury were followed every 2-4 weeks until a peak level of creatinine was detected.Renal recovery was examined every month after the peak creatinine level was reached. 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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General disorders
Hypocalcemia
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25.8%
300/1163 • Number of events 300 • Colonoscopy related complication was observed during and within one month after colonoscopy. Patient with acute renal injury were followed every 2-4 weeks until a peak level of creatinine was detected.Renal recovery was examined every month after the peak creatinine level was reached. 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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General disorders
Hypophosphatemia
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12.0%
139/1163 • Number of events 139 • Colonoscopy related complication was observed during and within one month after colonoscopy. Patient with acute renal injury were followed every 2-4 weeks until a peak level of creatinine was detected.Renal recovery was examined every month after the peak creatinine level was reached. 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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General disorders
Hyperchloremia
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6.6%
77/1163 • Number of events 77 • Colonoscopy related complication was observed during and within one month after colonoscopy. Patient with acute renal injury were followed every 2-4 weeks until a peak level of creatinine was detected.Renal recovery was examined every month after the peak creatinine level was reached. 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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General disorders
Hypokalemia
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4.5%
52/1163 • Number of events 52 • Colonoscopy related complication was observed during and within one month after colonoscopy. Patient with acute renal injury were followed every 2-4 weeks until a peak level of creatinine was detected.Renal recovery was examined every month after the peak creatinine level was reached. 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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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place