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

Hyponatremia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01299779
• Other study ID #: #10C.29
• Status: Completed
• Phase: N/A
• First received: July 12, 2010
• Last updated: June 4, 2013
• Start date: June 2010
• Est. completion date: September 2012

Study information

• Verified date: June 2013
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: September 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Hyponatremia

Intervention

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.
• PEG-ELS
1L + 500 cc clear liquids at 6 pm night prior 1L + 500 cc clear liquids starting 4 hours prior to colonoscopy

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Jefferson University	Valeant Pharmaceuticals International, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of hyponatremia in the peri-colonoscopy period		blood drawn 30 minutes post colonoscopy	Yes
Secondary	Development of serum electrolytes levels outside the normal range for	Sodium, chloride, potassium, calcium	blood drawn 30 minutes post colonoscopy	Yes
Secondary	Change from baseline for serum electrolytes	Sodium, chloride, potassium, calcium	blood drawn 30 minutes post colonoscopy	Yes
Secondary	Change in renal function from baseline	Creatinine, calculated GFR	blood drawn pre colonoscopy and 30 minutes post colonoscopy	Yes
Secondary	Changes in the following from baseline a. Serum vasopressin b. Serum osmolality c. Urine electrolytes and osmolality		blood drawn pre colonoscopy and 30 minutes post colonoscopy	Yes
Secondary	Serum cortisol and TSH levels for only patients who develop hyponatremia		blood drawn 30 minutes post colonoscopy	Yes
Secondary	Hemodynamic/volume changes at baseline and immediately prior to 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	hemodynamic measurments taken pre and post colonoscopy	Yes
Secondary	Adverse Events - Incidence and severity using 10-point Likert scale	GI - nausea, vomiting, abdominal pain, bloating; Light headedness	1 hour post colonoscopy assessment	Yes
Secondary	Prep Completion: <90% vs. > 90%		one time assessment pre colonoscopy	No
Secondary	Indication for colonoscopy: Screen/Surveillance vs. Symptom		one time assessment pre colonoscopy	No
Secondary	Assessment of independent risk factors for hyponatremia	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	one time assessment pre colonoscopy	No
Secondary	Efficacy	Whole colon prep: adequate (excellent/good) vs. inadequate (fair/poor); Cecal or small bowel intubation - Yes/No	endoscopist will evaluate during colonoscopy	No