Incidence of Hyponatremia in PEG-SD Compared to PEG-ELS
NCT ID: NCT01299779
Last Updated: 2013-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
460 participants
INTERVENTIONAL
2010-06-30
2012-09-30
Brief Summary
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Hypothesis: As compared to PEG-SD, hyponatremia occurs significantly less often with PEG-ELS.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SINGLE
Study Groups
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PEG-ELS
PEG-ELS
* 1L + 500 cc clear liquids at 6 pm night prior
* 1L + 500 cc clear liquids starting 4 hours prior to colonoscopy
PEG-SD
PEG-SD
PEG-SD
* Bisacodyl: two 5-mg tablets at 3 pm day prior
* 1L sports drink\* (labeled #1) with PEG-3350 119 gram bottle (labeled #1) at 6 pm night prior
* 1L SD\* (labeled #2) with PEG-3350 119 gram bottle (labeled #2) starting 4 hrs prior to colonoscopy
* Same flavor, non-red Gatorade® for all patients.
Interventions
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PEG-SD
PEG-SD
* Bisacodyl: two 5-mg tablets at 3 pm day prior
* 1L sports drink\* (labeled #1) with PEG-3350 119 gram bottle (labeled #1) at 6 pm night prior
* 1L SD\* (labeled #2) with PEG-3350 119 gram bottle (labeled #2) starting 4 hrs prior to colonoscopy
* Same flavor, non-red Gatorade® for all patients.
PEG-ELS
* 1L + 500 cc clear liquids at 6 pm night prior
* 1L + 500 cc clear liquids starting 4 hours prior to colonoscopy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnant
* Breast feeding
* Significant psychiatric illness
-\> 50% colon resection
* Bowel obstruction
* History of hyponatremia (Serum sodium \<135 mmol/L)
* End stage renal disease on dialysis
* History of chronic kidney disease (other than kidney stones)
* Decompensated cirrhosis, including:
* History of bleeding due to portal hypertension (varices, gastropathy, etc) within 3 months
* Hepatic encephalopathy (not controlled with medications) within 3 months
* Clinical presence of ascites
* Active cardiac disease
* Recent myocardial infarction (\<4weeks)
* Unstable angina
* Congestive heart failure NYHA Functional Class Stage III or IV
* Stage III: Marked limitation of activity. Less than ordinary activity (e.g. walking short distances, 20-100 m) causes fatigue, palpitations, dyspnea. Comfortable at rest.
* Stage IV: Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.
* Serum creatinine \> 1.5 mg/dL
* Serum potassium \< 3.3 or \> 5.5 mmol/L
* Serum sodium \< 135 mmol/L or \>150 mmol/L
* Serum calcium \< 8.0 or \> 11.0 mg/dL
18 Years
ALL
No
Sponsors
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Bausch Health Americas, Inc.
INDUSTRY
Thomas Jefferson University
OTHER
Responsible Party
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Principal Investigators
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David Kastenberg, MD
Role: PRINCIPAL_INVESTIGATOR
Thomas Jefferson University
Locations
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Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Countries
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References
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Matro R, Daskalakis C, Negoianu D, Katz L, Henry C, Share M, Kastenberg D. Randomised clinical trial: Polyethylene glycol 3350 with sports drink vs. polyethylene glycol with electrolyte solution as purgatives for colonoscopy--the incidence of hyponatraemia. Aliment Pharmacol Ther. 2014 Sep;40(6):610-9. doi: 10.1111/apt.12884. Epub 2014 Jul 28.
Other Identifiers
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#10C.29
Identifier Type: -
Identifier Source: org_study_id
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