Clinical trial NCT01299779: Incidence of Hyponatremia in PEG-SD Compared to PEG-ELS
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 3350 With Electrolyte Solution (PEG-ELS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyponatremia
Keywords: hyponatremia
PEG-SD
PEG-ELS
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Bausch Health Americas, Inc.
First posted: 2011-02-18
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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)

Eligibility criteria: 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

Primary outcomes:
measure: Development of hyponatremia in the peri-colonoscopy period
timeFrame: blood drawn 30 minutes post colonoscopy
Secondary outcomes:
measure: Development of serum electrolytes levels outside the normal range for
timeFrame: blood drawn 30 minutes post colonoscopy
measure: Change from baseline for serum electrolytes
timeFrame: blood drawn 30 minutes post colonoscopy
measure: Change in renal function from baseline
timeFrame: blood drawn pre colonoscopy and 30 minutes post colonoscopy
measure: Changes in the following from baseline a. Serum vasopressin b. Serum osmolality c. Urine electrolytes and osmolality
timeFrame: blood drawn pre colonoscopy and 30 minutes post colonoscopy
measure: Serum cortisol and TSH levels for only patients who develop hyponatremia
timeFrame: blood drawn 30 minutes post colonoscopy
measure: Hemodynamic/volume changes at baseline and immediately prior to colonoscopy
timeFrame: hemodynamic measurments taken pre and post colonoscopy
measure: Adverse Events - Incidence and severity using 10-point Likert scale
timeFrame: 1 hour post colonoscopy assessment
measure: Prep Completion: <90% vs. > 90%
timeFrame: one time assessment pre colonoscopy
measure: Indication for colonoscopy: Screen/Surveillance vs. Symptom
timeFrame: one time assessment pre colonoscopy
measure: Assessment of independent risk factors for hyponatremia
timeFrame: one time assessment pre colonoscopy
measure: Efficacy
timeFrame: endoscopist will evaluate during colonoscopy
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: David Kastenberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.