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.
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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
SINGLE
Enrollment
460
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.
* 1L + 500 cc clear liquids at 6 pm night prior * 1L + 500 cc clear liquids starting 4 hours prior to colonoscopy
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Development of hyponatremia in the peri-colonoscopy period
Time frame: blood drawn 30 minutes post colonoscopy
Development of serum electrolytes levels outside the normal range for
Sodium, chloride, potassium, calcium
Time frame: blood drawn 30 minutes post colonoscopy
Change from baseline for serum electrolytes
Sodium, chloride, potassium, calcium
Time frame: blood drawn 30 minutes post colonoscopy
Change in renal function from baseline
Creatinine, calculated GFR
Time frame: blood drawn pre colonoscopy and 30 minutes post colonoscopy
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
* 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
Time frame: hemodynamic measurments taken pre and post colonoscopy
Adverse Events - Incidence and severity using 10-point Likert scale
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* GI - nausea, vomiting, abdominal pain, bloating * Light headedness
Time frame: 1 hour post colonoscopy assessment
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
* 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
Time frame: one time assessment pre colonoscopy
Efficacy
* Whole colon prep: adequate (excellent/good) vs. inadequate (fair/poor) * Cecal or small bowel intubation - Yes/No
Time frame: endoscopist will evaluate during colonoscopy