NCT01299779

Incidence of Hyponatremia in PEG-SD Compared to PEG-ELS

The Incidence of Hyponatremia With Two Commonly Prescribed Purgatives for Colonoscopy-Polyethylene Glycol 3350 With a Sports Drink (PEG-SD) Compared to Polyethylene Glycol 3350 With Electrolyte Solution (PEG-ELS)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 460 (actual)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Objective: To compare the incidence of peri-colonoscopy hyponatremia associated with PEG 3350 + sports drink (PEG-SD) versus PEG 3350-electrolyte solution + sodium sulfate + sodium ascorbate and ascorbic acid (PEG-ELS). Hypothesis: As compared to PEG-SD, hyponatremia occurs significantly less often with PEG-ELS.

Detailed description

Looking at the Incidence of Hyponatremia With Two Commonly Prescribed Purgatives for Colonoscopy-Polyethylene Glycol 3350 With a Sports Drink (PEG-SD) Compared to Polyethylene Glycol 3350 With Electrolyte Solution (PEG-ELS)

Conditions

• Hyponatremia

Interventions

Type	Name	Description
DRUG	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.
DRUG	PEG-ELS	* 1L + 500 cc clear liquids at 6 pm night prior * 1L + 500 cc clear liquids starting 4 hours prior to colonoscopy

Timeline

• Start date: 2010-06-01
• Primary completion: 2012-05-01
• Completion: 2012-09-01
• First posted: 2011-02-18
• Last updated: 2013-06-05

Locations

1 site across 1 country: United States