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

Overview

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.

Full Title of Study: “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

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Investigator)
• Study Primary Completion Date: May 2012

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

• 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 colonoscopy Same flavor, non-red Gatorade® for all patients.
• Drug: PEG-ELS
  • 1L + 500 cc clear liquids at 6 pm night prior 1L + 500 cc clear liquids starting 4 hours prior to colonoscopy

Arms, Groups and Cohorts

• Active Comparator: PEG-ELS
• Active Comparator: PEG-SD

Clinical Trial Outcome Measures

Primary Measures

• Development of hyponatremia in the peri-colonoscopy period
  • Time Frame: blood drawn 30 minutes post colonoscopy

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Thomas Jefferson University
• Collaborator
  • Bausch Health Americas, Inc.
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • David Kastenberg, MD, Principal Investigator, Thomas Jefferson University