Hyponatremia
Conditions
Keywords
hyponatremia, PEG-SD, PEG-ELS
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 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)
Interventions
DRUGPEG-SD
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.
DRUGPEG-ELS
* 1L + 500 cc clear liquids at 6 pm night prior * 1L + 500 cc clear liquids starting 4 hours prior to colonoscopy
Sponsors
Bausch Health Americas, Inc.
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Development of hyponatremia in the peri-colonoscopy period | blood drawn 30 minutes post colonoscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline for serum electrolytes | blood drawn 30 minutes post colonoscopy | Sodium, chloride, potassium, calcium |
| Change in renal function from baseline | 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 | 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 | 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 |
| Development of serum electrolytes levels outside the normal range for | blood drawn 30 minutes post colonoscopy | Sodium, chloride, potassium, calcium |
| 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 | 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 | endoscopist will evaluate during colonoscopy | * Whole colon prep: adequate (excellent/good) vs. inadequate (fair/poor) * Cecal or small bowel intubation - Yes/No |
| Adverse Events - Incidence and severity using 10-point Likert scale | 1 hour post colonoscopy assessment | * GI - nausea, vomiting, abdominal pain, bloating * Light headedness |
Countries
United States
Outcome results
None listed