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

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ClinicalTrials.gov Identifier: NCT01299779
Recruitment Status : Completed
First Posted : February 18, 2011
Last Update Posted : June 5, 2013
Sponsor:
Collaborator:
Valeant Pharmaceuticals International, Inc.
Information provided by (Responsible Party):
Thomas Jefferson University

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.


Condition or disease Intervention/treatment Phase
Hyponatremia Drug: PEG-SD Drug: PEG-ELS Not Applicable

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  (Clinical Trial)
Actual Enrollment : 460 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
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 Start Date : June 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

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 Name: 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 colonoscopy

    • Same flavor, non-red Gatorade® for all patients.
Other Name: Miralax




Primary Outcome Measures :
  1. Development of hyponatremia in the peri-colonoscopy period [ Time Frame: blood drawn 30 minutes post colonoscopy ]

Secondary Outcome Measures :
  1. Development of serum electrolytes levels outside the normal range for [ Time Frame: blood drawn 30 minutes post colonoscopy ]
    Sodium, chloride, potassium, calcium

  2. Change from baseline for serum electrolytes [ Time Frame: blood drawn 30 minutes post colonoscopy ]
    Sodium, chloride, potassium, calcium

  3. Change in renal function from baseline [ Time Frame: blood drawn pre colonoscopy and 30 minutes post colonoscopy ]
    Creatinine, calculated GFR

  4. 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 ]
  5. Serum cortisol and TSH levels for only patients who develop hyponatremia [ Time Frame: blood drawn 30 minutes post colonoscopy ]
  6. 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

  7. 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

  8. Prep Completion: <90% vs. > 90% [ Time Frame: one time assessment pre colonoscopy ]
  9. Indication for colonoscopy: Screen/Surveillance vs. Symptom [ Time Frame: one time assessment pre colonoscopy ]
  10. 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


  11. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01299779


Locations
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Valeant Pharmaceuticals International, Inc.
Investigators
Principal Investigator: David Kastenberg, MD Thomas Jefferson University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01299779     History of Changes
Other Study ID Numbers: #10C.29
First Posted: February 18, 2011    Key Record Dates
Last Update Posted: June 5, 2013
Last Verified: June 2013

Keywords provided by Thomas Jefferson University:
hyponatremia
PEG-SD
PEG-ELS

Additional relevant MeSH terms:
Hyponatremia
Water-Electrolyte Imbalance
Metabolic Diseases
Polyethylene glycol 3350
Laxatives
Gastrointestinal Agents