Incidence of Diarrhea Using High and Low Osmolality Enteral Tube Feeding in Critically Ill Surgical Patients

NCT ID: NCT03487744

Last Updated: 2019-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-02

Study Completion Date

2019-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Tube Feeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Promote without fiber

Lower osmolality enteral tube feed formulation

Group Type ACTIVE_COMPARATOR

Promote without fiber

Intervention Type OTHER

Continuous enteral tube feeding according to a standardized calculation via nasojejunal tube.

Osmolite 1.5

Higher osmolality enteral tube feed formulation

Group Type ACTIVE_COMPARATOR

Osmolite 1.5

Intervention Type OTHER

Continuous enteral tube feeding according to a standardized calculation via nasojejunal tube.

Interventions

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Osmolite 1.5

Continuous enteral tube feeding according to a standardized calculation via nasojejunal tube.

Intervention Type OTHER

Promote without fiber

Continuous enteral tube feeding according to a standardized calculation via nasojejunal tube.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* age \>18 years
* admitted to SICU or CVICU requiring TF for enteral nutrition
* anticipated ICU stay and TF requirement \>72 hours

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Amanda Zomp

Clinical Pharmacist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Utah Health

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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IRB_00108798

Identifier Type: -

Identifier Source: org_study_id

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