HyponatremiaNCT01299779
Incidence of Hyponatremia in PEG-SD Compared to PEG-ELS
A study testing PEG-SD and PEG-ELS in people with Hyponatremia, run by Thomas Jefferson University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyponatremia
- What is being tested?
- PEG-SD and PEG-ELS
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults age 18 years or older scheduled for elective outpatient colonoscopy: 8am - noon.
Who cannot join
- Unable or unwilling to consent
- Pregnant
- Breast feeding
- Significant psychiatric illness
- -> 50% colon resection
- Bowel obstruction
Show all 23Show fewer
- 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.
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
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)
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.
Read the 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)
- Conditions
- Hyponatremia
- Being tested
- PEG-SD, PEG-ELS
- Keywords
- hyponatremia, PEG-SD, PEG-ELS
- Medical subject headings
- Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-SDDrug
Also called Miralax
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-ELSDrug
Also called MoviPrep
- 1L + 500 cc clear liquids at 6 pm night prior
- 1L + 500 cc clear liquids starting 4 hours prior to colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| PEG-ELS | Active comparator | Not described Receives: Drug: PEG-ELS |
| PEG-SD | Active comparator | Not described Receives: Drug: PEG-SD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of hyponatremia in the peri-colonoscopy period
Measured: blood drawn 30 minutes post colonoscopy
Secondary outcomes (11)
Development of serum electrolytes levels outside the normal range for
Sodium, chloride, potassium, calcium
Measured: blood drawn 30 minutes post colonoscopy
Change from baseline for serum electrolytes
Sodium, chloride, potassium, calcium
Measured: blood drawn 30 minutes post colonoscopy
Change in renal function from baseline
Creatinine, calculated GFR
Measured: 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
Measured: blood drawn pre colonoscopy and 30 minutes post colonoscopy
Serum cortisol and TSH levels for only patients who develop hyponatremia
Measured: blood drawn 30 minutes post colonoscopy
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
Measured: hemodynamic measurments taken pre and post colonoscopy
Adverse Events - Incidence and severity using 10-point Likert scale
- GI - nausea, vomiting, abdominal pain, bloating
- Light headedness
Measured: 1 hour post colonoscopy assessment
Prep Completion: <90% vs. > 90%
Measured: one time assessment pre colonoscopy
Indication for colonoscopy: Screen/Surveillance vs. Symptom
Measured: one time assessment pre colonoscopy
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.
- Less than 3 Liters ii. 3-5 liters iii. More than 5 liters
Measured: one time assessment pre colonoscopy
Efficacy
- Whole colon prep: adequate (excellent/good) vs. inadequate (fair/poor)
- Cecal or small bowel intubation - Yes/No
Measured: endoscopist will evaluate during colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startJun 2010
- Primary completionMay 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyponatremiaStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Bausch Health Americas, Inc.
- Responsible party
- Sponsor
- Investigators
- David Kastenberg, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01299779
- Sponsor's protocol ID
- #10C.29
- Status last verified
- Jun 2013
- First submitted
- 12 Jul 2010
- Last updated
- 5 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25066025
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01299779
- Acronym / sponsor ID
- #10C.29
- Conditions
- Hyponatremia
- Keywords
- hyponatremia, PEG-SD, PEG-ELS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Bausch Health Americas, Inc.
- Study start
- Jun 2010
- Primary completion
- May 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 18 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG-ELS | Active comparator | Drug: PEG-ELS |
| PEG-SD | Active comparator | Drug: PEG-SD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults age 18 years or older scheduled for elective outpatient colonoscopy: 8am - noon.
Key exclusion criteria (23 listed)
- Unable or unwilling to consent
- Pregnant
- Breast feeding
- Significant psychiatric illness
- -> 50% colon resection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEG-SDAlso: MiralaxPEG-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. | Drug | PEG-SD |
| PEG-ELSAlso: MoviPrep* 1L + 500 cc clear liquids at 6 pm night prior * 1L + 500 cc clear liquids starting 4 hours prior to colonoscopy | Drug | PEG-ELS |
Primary outcome
Development of hyponatremia in the peri-colonoscopy period
Time frame: blood drawn 30 minutes post colonoscopy
11 secondary outcomes
Development of serum electrolytes levels outside the normal range for
Time frame: blood drawn 30 minutes post colonoscopy
Change from baseline for serum electrolytes
Time frame: blood drawn 30 minutes post colonoscopy
Change in renal function from baseline
Time frame: 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
Time frame: blood drawn pre colonoscopy and 30 minutes post colonoscopy
Serum cortisol and TSH levels for only patients who develop hyponatremia
Time frame: blood drawn 30 minutes post colonoscopy
Hemodynamic/volume changes at baseline and immediately prior to colonoscopy
Time frame: hemodynamic measurments taken pre and post colonoscopy
Adverse Events - Incidence and severity using 10-point Likert scale
Time frame: 1 hour post colonoscopy assessment
Prep Completion: <90% vs. > 90%
Time frame: one time assessment pre colonoscopy
Indication for colonoscopy: Screen/Surveillance vs. Symptom
Time frame: one time assessment pre colonoscopy
Assessment of independent risk factors for hyponatremia
Time frame: one time assessment pre colonoscopy
Efficacy
Time frame: endoscopist will evaluate during colonoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2013.
- Derived from this study: PubMed 25066025Matro 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Kastenberg, MD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEG-SD and PEG-ELS in people with Hyponatremia, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of hyponatremia in the peri-colonoscopy period (time frame: blood drawn 30 minutes post colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01299779, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2013.