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

Thomas Jefferson University

Status

Completed

Conditions

Hyponatremia

Treatments

Drug: PEG-SD

Drug: PEG-ELS

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01299779

#10C.29

Details and patient eligibility

About

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.

Full 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)

Enrollment

460 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adults age 18 years or older scheduled for elective outpatient colonoscopy: 8am - noon.

Exclusion criteria

Unable or unwilling to consent
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.