Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Bausch Health Americas, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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)
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG-ELS | Active Comparator |
| |
| PEG-SD | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG-SD | Drug | PEG-SD
|
| Measure | Description | Time Frame |
|---|---|---|
| Development of hyponatremia in the peri-colonoscopy period | blood drawn 30 minutes post colonoscopy |
| 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 |
Not provided
Inclusion Criteria:
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:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David Kastenberg, MD | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25066025 | Derived | Matro R, Daskalakis C, Negoianu D, Katz L, Henry C, Share M, Kastenberg D. Randomised clinical trial: Polyethylene glycol 3350 with sports drink vs. polyethylene glycol with electrolyte solution as purgatives for colonoscopy--the incidence of hyponatraemia. Aliment Pharmacol Ther. 2014 Sep;40(6):610-9. doi: 10.1111/apt.12884. Epub 2014 Jul 28. |
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 28, 2023 | |
| Reset | Dec 19, 2023 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 28, 2023 | Dec 19, 2023 |
| ID | Term |
|---|---|
| D007010 | Hyponatremia |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000595212 | polyethylene glycol 3350 |
| C520497 | MoviPrep |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| PEG-ELS | Drug |
|
|
|
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 |
| hemodynamic measurments taken pre and post colonoscopy |
| Adverse Events - Incidence and severity using 10-point Likert scale |
| 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 |
| one time assessment pre colonoscopy |
| Efficacy |
| endoscopist will evaluate during colonoscopy |