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

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.