NCT01299779

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
460

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 12, 2010

Completed
7 months until next milestone

First Posted

Study publicly available on registry

February 18, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

June 5, 2013

Status Verified

June 1, 2013

Enrollment Period

1.9 years

First QC Date

July 12, 2010

Last Update Submit

June 4, 2013

Conditions

Hyponatremia

Keywords

hyponatremiaPEG-SDPEG-ELS

Outcome Measures

Primary Outcomes (1)

  • Development of hyponatremia in the peri-colonoscopy period

    blood drawn 30 minutes post colonoscopy

Secondary Outcomes (11)

  • Development of serum electrolytes levels outside the normal range for

    blood drawn 30 minutes post colonoscopy

  • Change from baseline for serum electrolytes

    blood drawn 30 minutes post colonoscopy

  • Change in renal function from baseline

    blood drawn pre colonoscopy and 30 minutes post colonoscopy

  • 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

  • +6 more secondary outcomes

Study Arms (2)

PEG-ELS

ACTIVE COMPARATOR
Drug: PEG-ELS

PEG-SD

ACTIVE COMPARATOR
Drug: PEG-SD

Interventions

PEG-SDDRUG

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.

Also known as: Miralax
PEG-SD
PEG-ELSDRUG

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

Also known as: MoviPrep
PEG-ELS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults age 18 years or older scheduled for elective outpatient colonoscopy: 8am - noon.

You may not qualify if:

  • 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)
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

  • Matro R, Daskalakis C, Negoianu D, Katz L, Henry C, Share M, Kastenberg D. Randomised clinical trial: Polyethylene glycol 3350 with sports drink vs. polyethylene glycol with electrolyte solution as purgatives for colonoscopy--the incidence of hyponatraemia. Aliment Pharmacol Ther. 2014 Sep;40(6):610-9. doi: 10.1111/apt.12884. Epub 2014 Jul 28.

    PMID: 25066025DERIVED

MeSH Terms

Conditions

Hyponatremia

Interventions

polyethylene glycol 3350MoviPrep

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • David Kastenberg, MD

    Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2010

First Posted

February 18, 2011

Study Start

June 1, 2010

Primary Completion

May 1, 2012

Study Completion

September 1, 2012

Last Updated

June 5, 2013

Record last verified: 2013-06

Locations

US(1)