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

Not Applicable

Completed

• Conditions: Hyponatremia
• Interventions: Drug: PEG-ELS; Drug: PEG-SD

• Registration Number: NCT01299779
• Lead Sponsor: Thomas Jefferson University

Brief 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.

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)

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-07-12
• Study First Submitted QC: 2011-02-17
• Study First Posted: 2011-02-18
• Primary Completion: 2012-05
• Study Completion: 2012-09
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-04
• Last Update Posted: 2013-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 460

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEG-ELS	PEG-ELS	-
PEG-SD	PEG-SD	-

Primary Outcome Measures

Name	Time	Method
Development of hyponatremia in the peri-colonoscopy period	blood drawn 30 minutes post colonoscopy

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States