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

This study has been completed.
Sponsor:
Collaborator:
Salix Pharmaceuticals
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT01299779
First received: July 12, 2010
Last updated: June 4, 2013
Last verified: June 2013
  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:


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


Enrollment: 460
Study Start Date: June 2010
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: June 4, 2013
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 July 29, 2014