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

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)

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.

Study Overview

• Status: Completed
• Conditions: Hyponatremia
• Intervention / Treatment: Drug: PEG-ELS; Drug: PEG-SD

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)

• Study Type: Interventional
• Enrollment (Actual): 460
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PEG-ELS	Drug: PEG-ELS; 1L + 500 cc clear liquids at 6 pm night prior; 1L + 500 cc clear liquids starting 4 hours prior to colonoscopy; Other Names: MoviPrep
Active Comparator: PEG-SD	Drug: PEG-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 colonoscopySame flavor, non-red Gatorade® for all patients.; Other Names: Miralax

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Collaborators: Bausch Health Americas, Inc.
• Investigators: Principal Investigator: David Kastenberg, MD, Thomas Jefferson University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: July 12, 2010
• First Submitted That Met QC Criteria: February 17, 2011
• First Posted (Estimate): February 18, 2011

Study Record Updates

• Last Update Posted (Estimate): June 5, 2013
• Last Update Submitted That Met QC Criteria: June 4, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: hyponatremia; PEG-SD; PEG-ELS
• Additional Relevant MeSH Terms: Metabolic Diseases; Water-Electrolyte Imbalance; Hyponatremia; Gastrointestinal Agents; Laxatives; Polyethylene glycol 3350
• Other Study ID Numbers: #10C.29

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No