Tube FeedingNCT03487744
Incidence of Diarrhea Using High and Low Osmolality Enteral Tube Feeding in Critically Ill Surgical Patients
A study testing Osmolite 1.5 and Promote without fiber in people with Tube Feeding, run by University of Utah at 1 site in United States.
Trial summary
The purpose and primary objective of this study is to determine if there is an association between enteral tube feed (TF) osmolality and diarrhea in critically ill patients. The investigators hypothesize that the administration of a TF formulation with high osmolality will cause more diarrhea than a TF formulation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tube Feeding
- What is being tested?
- Osmolite 1.5 and Promote without fiber
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2018to 30 Jun 2019
- 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
- age >18 years
- admitted to SICU or CVICU requiring TF for enteral nutrition
- anticipated ICU stay and TF requirement >72 hours
Who cannot join
- Contraindication to receiving one of the study TF formulations
- Inability to tolerate at least 75% of estimated requirement by day 3 of enteral TF administration
- Clostridium difficile infection or other cause of infectious diarrhea prior to study enrollment
- Presence of an ileostomy or colostomy
- History of inflammatory bowel disease, bowel resection, short gut syndrome, or chronic diarrhea
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Health
Salt Lake City, Utah, 84112
About this study
Official title: Comparison of the Incidence of Diarrhea Using High and Low Osmolality Enteral Tube Feeding in Critically Ill Surgical Patients
The purpose and primary objective of this study is to determine if there is an association between enteral tube feed (TF) osmolality and diarrhea in critically ill patients. The investigators hypothesize that the administration of a TF formulation with high osmolality will cause more diarrhea than a TF formulation with a lower osmolality.
- Conditions
- Tube Feeding
- Being tested
- Osmolite 1.5, Promote without fiber
- Keywords
- Tube Feeding, Diarrhea, Enteral Nutrition, Critically Ill, Surgical, Cardiovascular
- Medical subject headings
- Diarrhea, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osmolite 1.5Other
Continuous enteral tube feeding according to a standardized calculation via nasojejunal tube.
Promote without fiberOther
Continuous enteral tube feeding according to a standardized calculation via nasojejunal tube.
| Study group | Role | What they receive |
|---|---|---|
| Promote without fiber | Active comparator | Lower osmolality enteral tube feed formulation Receives: Other: Promote without fiber |
| Osmolite 1.5 | Active comparator | Higher osmolality enteral tube feed formulation Receives: Other: Osmolite 1.5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of diarrhea at 72 hours
Measured: 72 hour
Secondary outcomes (8)
Incidence of diarrhea at 14 days
Measured: 14 days
Mean frequency of diarrhea days
Measured: 14 days
Total number of diarrhea days
Measured: 14 days
Mean diarrhea scores
Hart and Dobb Diarrhea Scale (a tool based on consistency and size of each stool, with a sum of all stools in one day equaling the score for each day and a score of 12 or more indicates diarrhea)
Measured: 14 days
Time at 75% or more of goal tube feeding rate
Measured: 14 days
Incidence of hypokalemia
Measured: 14 days
Incidence of perineal dermatitis
Measured: 14 days
Number of Clostridium difficile assays sent
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2018
- Study start2 Jul 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Why it stopped: slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tube FeedingStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amanda Zomp, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03487744
- Sponsor's protocol ID
- IRB_00108798
- Status last verified
- Jul 2019
- First submitted
- 20 Mar 2018
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Incidence of Diarrhea Using High and Low Osmolality Enteral Tube Feeding in Critically Ill Surgical Patients
- ClinicalTrials.gov ID
- NCT03487744
- Acronym / sponsor ID
- IRB_00108798
- Conditions
- Tube Feeding
- Keywords
- Tube Feeding, Diarrhea, Enteral Nutrition, Critically Ill, Surgical, Cardiovascular
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow enrollment
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 4 Apr 2018 (actual)
- 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.
The purpose and primary objective of this study is to determine if there is an association between enteral tube feed (TF) osmolality and diarrhea in critically ill patients. The investigators hypothesize that the administration of a TF formulation with high osmolality will cause more diarrhea than a TF formulation with a lower osmolality.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Promote without fiber | Active comparator | Other: Promote without fiberLower osmolality enteral tube feed formulation |
| Osmolite 1.5 | Active comparator | Other: Osmolite 1.5Higher osmolality enteral tube feed formulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age >18 years
- admitted to SICU or CVICU requiring TF for enteral nutrition
- anticipated ICU stay and TF requirement >72 hours
Key exclusion criteria (5 listed)
- Contraindication to receiving one of the study TF formulations
- Inability to tolerate at least 75% of estimated requirement by day 3 of enteral TF administration
- Clostridium difficile infection or other cause of infectious diarrhea prior to study enrollment
- Presence of an ileostomy or colostomy
- History of inflammatory bowel disease, bowel resection, short gut syndrome, or chronic diarrhea
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 |
|---|---|---|
| Osmolite 1.5Continuous enteral tube feeding according to a standardized calculation via nasojejunal tube. | Other | Osmolite 1.5 |
| Promote without fiberContinuous enteral tube feeding according to a standardized calculation via nasojejunal tube. | Other | Promote without fiber |
Primary outcome
Incidence of diarrhea at 72 hours
Time frame: 72 hour
8 secondary outcomes
Incidence of diarrhea at 14 days
Time frame: 14 days
Mean frequency of diarrhea days
Time frame: 14 days
Total number of diarrhea days
Time frame: 14 days
Mean diarrhea scores
Time frame: 14 days
Time at 75% or more of goal tube feeding rate
Time frame: 14 days
Incidence of hypokalemia
Time frame: 14 days
Incidence of perineal dermatitis
Time frame: 14 days
Number of Clostridium difficile assays sent
Time frame: 14 days
Results and safety
The study was stopped early (reason given: slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osmolite 1.5 and Promote without fiber in people with Tube Feeding, run by University of Utah 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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 23 Jul 2019. 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 was stopped early (reason given: slow enrollment). Results are not available in the source record.
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?
Incidence of diarrhea at 72 hours (time frame: 72 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2019.