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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Salix Pharmaceuticals
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT01299779
First received: July 12, 2010
Last updated: May 27, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention
Hyponatremia
 Drug: PEG-SD
Drug: PEG-ELS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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)

Resource links provided by NLM:

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Development of hyponatremia in the peri-colonoscopy period [ Time Frame: blood drawn 30 minutes post colonoscopy ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Development of serum electrolytes levels outside the normal range for [ Time Frame: blood drawn 30 minutes post colonoscopy ] [ Designated as safety issue: Yes ]
    Sodium, chloride, potassium, calcium

  • Change from baseline for serum electrolytes [ Time Frame: blood drawn 30 minutes post colonoscopy ] [ Designated as safety issue: Yes ]
    Sodium, chloride, potassium, calcium

  • Change in renal function from baseline [ Time Frame: blood drawn pre colonoscopy and 30 minutes post colonoscopy ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • Serum cortisol and TSH levels for only patients who develop hyponatremia [ Time Frame: blood drawn 30 minutes post colonoscopy ] [ Designated as safety issue: Yes ]
  • Hemodynamic/volume changes at baseline and immediately prior to colonoscopy [ Time Frame: hemodynamic measurments taken pre and post colonoscopy ] [ Designated as safety issue: Yes ]
    • 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 ] [ Designated as safety issue: Yes ]
    • GI - nausea, vomiting, abdominal pain, bloating
    • Light headedness

  • Prep Completion: <90% vs. > 90% [ Time Frame: one time assessment pre colonoscopy ] [ Designated as safety issue: No ]
  • Indication for colonoscopy: Screen/Surveillance vs. Symptom [ Time Frame: one time assessment pre colonoscopy ] [ Designated as safety issue: No ]
  • Assessment of independent risk factors for hyponatremia [ Time Frame: one time assessment pre colonoscopy ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    • Whole colon prep: adequate (excellent/good) vs. inadequate (fair/poor)
    • Cecal or small bowel intubation - Yes/No


Estimated Enrollment: 460
Study Start Date: June 2010
Estimated Study Completion Date: September 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01299779

Locations
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Salix Pharmaceuticals
Investigators
Principal Investigator: David Kastenberg, MD Thomas Jefferson University
  More Information

No publications provided

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01299779     History of Changes
Other Study ID Numbers: #10C.29
Study First Received: July 12, 2010
Last Updated: May 27, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Hyponatremia
Water-Electrolyte Imbalance
Metabolic Diseases

ClinicalTrials.gov processed this record on May 22, 2013