|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02657564 |
|
Date of registration:
|
17/11/2015 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Renal Safety of Bowel Preparation With Polyethylene Glycol
|
|
Scientific title:
|
The Renal Safety of Bowel Preparation With Polyethylene Glycol for Colonoscopy: A Prospective Cohort Study |
|
Date of first enrolment:
|
January 1, 2016 |
|
Target sample size:
|
1237 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02657564 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Health Services Research. Masking: None (Open Label).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Taiwan
| | | | | | | |
|
Contacts
|
|
Name:
|
Chiliang Cheng, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Zhongli Evergreen General Hospital, Taiwan |
| | |
|
Key inclusion & exclusion criteria
|
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
Age minimum:
40 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Acute Kidney Injury
|
|
Intervention(s)
|
|
Drug: Polyethylene glycol (PEG)
|
|
Primary Outcome(s)
|
|
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.]
|
|
Secondary Outcome(s)
|
|
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.]
|
|
Secondary ID(s)
|
|
ZEH-2016-1
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|