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

July 18, 2019 updated by: Amanda Zomp, University of Utah

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • University of Utah Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Promote without fiber
Lower osmolality enteral tube feed formulation
Other: Promote without fiber
Continuous enteral tube feeding according to a standardized calculation via nasojejunal tube.
ACTIVE_COMPARATOR: Osmolite 1.5
Higher osmolality enteral tube feed formulation
Other: Osmolite 1.5
Continuous enteral tube feeding according to a standardized calculation via nasojejunal tube.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of diarrhea at 72 hours
Time Frame: 72 hour
72 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of diarrhea at 14 days
Time Frame: 14 days
14 days
Mean frequency of diarrhea days
Time Frame: 14 days
14 days
Total number of diarrhea days
Time Frame: 14 days
14 days
Mean diarrhea scores
Time Frame: 14 days
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)
14 days
Time at 75% or more of goal tube feeding rate
Time Frame: 14 days
14 days
Incidence of hypokalemia
Time Frame: 14 days
14 days
Incidence of perineal dermatitis
Time Frame: 14 days
14 days
Number of Clostridium difficile assays sent
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 2, 2018

Primary Completion (ACTUAL)

June 30, 2019

Study Completion (ACTUAL)

June 30, 2019

Study Registration Dates

First Submitted

March 20, 2018

First Submitted That Met QC Criteria

March 27, 2018

First Posted (ACTUAL)

April 4, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 23, 2019

Last Update Submitted That Met QC Criteria

July 18, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB_00108798

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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