Clinical Trial: Incidence of Hyponatremia in PEG-SD Compared to PEG-ELS

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary: 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)
Sponsor: Thomas Jefferson University

Current Primary Outcome: Development of hyponatremia in the peri-colonoscopy period [ Time Frame: blood drawn 30 minutes post colonoscopy ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Development of serum electrolytes levels outside the normal range for [ Time Frame: blood drawn 30 minutes post colonoscopy ]
    Sodium, chloride, potassium, calcium
  • Change from baseline for serum electrolytes [ Time Frame: blood drawn 30 minutes post colonoscopy ]
    Sodium, chloride, potassium, calcium
  • Change in renal function from baseline [ Time Frame: blood drawn pre colonoscopy and 30 minutes post colonoscopy ]
    Creatinine, calculated GFR
  • Changes in the following from baseline a. Serum vasopressin b. Serum osmolality c. Urine electrolytes and osmolality [ Time Frame: blood drawn pre colonoscopy and 30 minutes post colonoscopy ]
  • Serum cortisol and TSH levels for only patients who develop hyponatremia [ Time Frame: blood drawn 30 minutes post colonoscopy ]
  • Hemodynamic/volume changes at baseline and immediately prior to colonoscopy [ Time Frame: hemodynamic measurments taken pre and post colonoscopy ]
    • Weight
    • Blood pressure supine and upright - systolic, diastolic
    • Pulse supine and upright
    • Development of orthostatic change: yes/no
    • Development of orthostatic symptoms - light-headed, dizzy, diaphoretic, etc.: yes/no
  • Adverse Events - Incidence and severity using 10-point Likert scale [ Time Frame: 1 hour post colonoscopy assessment ]
    • GI - nausea, vomiting, abdominal pain, bloating
    • Light headedness
  • Prep Completion: <90% vs. > 90% [ Time Frame: one time assessment pre colonoscopy ]
  • Indication for colonoscopy: Screen/Surveillance vs. Symptom [ Time Frame: one time assessment pre colonoscopy ]
  • Assessment of independent risk factors for hyponatremia [ Time Frame: one time assessment pre colonoscopy ]
    • Age
    • Sex
    • Race
    • Medications
    • Medical history
    • BMI
    • Anxiety - Beck scale

    • Fluid intake for 24 hours prior to colonoscopy (not including the prep or fluids required to accompany the prep); patients will be shown a liter container to assist with their estimate.

      i. Less than 3 Liters ii. 3-5 liters iii. More than 5 liters

  • Efficacy [ Time Frame: endoscopist will evaluate during colonoscopy ]
    • Whole colon prep: adequate (excellent/good) vs. inadequate (fair/poor)
    • Cecal or small bowel intubation - Yes/No


Original Secondary Outcome: Same as current

Information By: Thomas Jefferson University

Dates:
Date Received: July 12, 2010
Date Started: June 2010
Date Completion:
Last Updated: June 4, 2013
Last Verified: June 2013