Acute Kidney InjuryNCT02657564
Renal Safety of Bowel Preparation With Polyethylene Glycol
A study testing Polyethylene glycol (PEG) in people with Acute Kidney Injury, run by Evergreen General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
This study evaluates the changes of renal function after taking bowel cleansing agent polyethylene glycol for elective colonoscopy. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Polyethylene glycol (PEG)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,237 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2016to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects 40 yrs of age or older scheduled for elective colonoscopy.
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Renal Safety of Bowel Preparation With Polyethylene Glycol for Colonoscopy: A Prospective Cohort Study
This study evaluates the changes of renal function after taking bowel cleansing agent polyethylene glycol for elective colonoscopy.
Read the 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.
- Conditions
- Acute Kidney Injury
- Being tested
- Polyethylene glycol (PEG)
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyethylene glycol (PEG)Drug
Also called Klean-Prep
Participants receive blood tests for serum creatinine and electrolytes (Ca, P, Cl, Mg, Na, K) before and after taking polythylene glycol.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Polyethylene glycol (PEG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2016 (estimated)
- Study start1 Jan 2016
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evergreen General Hospital, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chi-Liang Cheng, Evergreen General Hospital, Taiwan
- Investigators
- Chiliang Cheng, MD, Principal investigator, Zhongli Evergreen General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02657564
- Sponsor's protocol ID
- ZEH-2016-1
- Status last verified
- Feb 2019
- First submitted
- 17 Nov 2015
- Last updated
- 5 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Renal Safety of Bowel Preparation With Polyethylene Glycol for Colonoscopy: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02657564
- Acronym / sponsor ID
- ZEH-2016-1
- Conditions
- Acute Kidney Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,237 participants (actual)
- Lead sponsor
- Evergreen General Hospital, TaiwanUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 18 Jan 2016 (estimated)
- Results
- Posted 5 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Polyethylene glycol (PEG) | Other | Drug: 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects 40 yrs of age or older scheduled for elective colonoscopy.
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polyethylene glycol (PEG)Also: Klean-PrepParticipants receive blood tests for serum creatinine and electrolytes (Ca, P, Cl, Mg, Na, K) before and after taking polythylene glycol. | Drug | Polyethylene glycol (PEG) |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chiliang Cheng, MD principal investigator
Zhongli Evergreen General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyethylene glycol (PEG) in people with Acute Kidney Injury, run by Evergreen General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2019.