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Completed

NCT Number: NCT01299779

Incidence of Hyponatremia in PEG-SD Compared to 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.

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Key information

Conditions

Hyponatremia Metabolic Diseases Nutritional and Metabolic Diseases Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PEG-SD

Drug

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 names: Miralax

PEG-ELS

Drug
  • 1L + 500 cc clear liquids at 6 pm night prior
  • 1L + 500 cc clear liquids starting 4 hours prior to colonoscopy

Other names: MoviPrep

Primary outcomes

  1. Development of hyponatremia in the peri-colonoscopy period

    Time frame: blood drawn 30 minutes post colonoscopy

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Collaborators

  • Bausch Health Americas, Inc.

Registry information

Official study 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)

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Feb 18, 2011
Registry last updated
Jun 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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