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

Completed · Not applicable

Conditions studied: Hyponatremia

In brief

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.

Key facts

Study ID

NCT01299779

Run by

Thomas Jefferson University

People needed

460

Starts

2010-06-01

Expected to finish

2012-09-01

Last updated by the study team

2013-06-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.
• Exclusion Criteria (post-enrollment), from baseline labs:
• 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

Where it is running

• Thomas Jefferson University — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.