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

Study Overview
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Brief Summary
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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
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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)

Official Title
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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
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Hyponatremia

Intervention / Treatment
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* Drug: PEG-SD
* Drug: PEG-ELS


Participation Criteria
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Eligibility Criteria
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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. 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PEG-ELS<br> | Drug: PEG-ELS<br>* 1L + 500 cc clear liquids at 6 pm night prior 1L + 500 cc clear liquids starting 4 hours prior to colonoscopy<br>* Other names: MoviPrep;|
| Active Comparator: PEG-SD<br> | Drug: PEG-SD<br>* 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.<br>* Other names: Miralax;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of hyponatremia in the peri-colonoscopy period |  | blood drawn 30 minutes post colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of serum electrolytes levels outside the normal range for | Sodium, chloride, potassium, calcium | blood drawn 30 minutes post colonoscopy | 
| Change from baseline for serum electrolytes | Sodium, chloride, potassium, calcium | blood drawn 30 minutes post colonoscopy | 
| Change in renal function from baseline | Creatinine, calculated GFR | 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 |  | blood drawn pre colonoscopy and 30 minutes post colonoscopy | 
| Serum cortisol and TSH levels for only patients who develop hyponatremia |  | 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 | hemodynamic measurments taken pre and post colonoscopy | 
| Adverse Events - Incidence and severity using 10-point Likert scale | GI - nausea, vomiting, abdominal pain, bloating Light headedness | 1 hour post colonoscopy assessment | 
| Prep Completion: <90% vs. > 90% |  | one time assessment pre colonoscopy | 
| Indication for colonoscopy: Screen/Surveillance vs. Symptom |  | 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 | one time assessment pre colonoscopy | 
| Efficacy | Whole colon prep: adequate (excellent/good) vs. inadequate (fair/poor) Cecal or small bowel intubation - Yes/No | endoscopist will evaluate during colonoscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hyponatremia, PEG-SD, PEG-ELS