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

July 12, 2010
June 4, 2013
June 2010
May 2012   (final data collection date for primary outcome measure)
Development of hyponatremia in the peri-colonoscopy period [ Time Frame: blood drawn 30 minutes post colonoscopy ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01299779 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Incidence of Hyponatremia in PEG-SD Compared to PEG-ELS
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)

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.

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)

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Hyponatremia
  • 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
  • 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-ELS
    Intervention: Drug: PEG-ELS
  • Active Comparator: PEG-SD
    Intervention: Drug: PEG-SD
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
460
September 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01299779
#10C.29
No
Thomas Jefferson University
Thomas Jefferson University
Salix Pharmaceuticals
Principal Investigator: David Kastenberg, MD Thomas Jefferson University
Thomas Jefferson University
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP