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

Not Applicable

Terminated

• Conditions: Tube Feeding
• Interventions: Other: Osmolite 1.5; Other: Promote without fiber

• Registration Number: NCT03487744
• Lead Sponsor: University of Utah

Brief 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 with a lower osmolality.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-20
• Study First Submitted QC: 2018-03-27
• Study First Posted: 2018-04-04
• Study Start: 2018-07-02
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-18
• Last Update Posted: 2019-07-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Osmolite 1.5	Osmolite 1.5	Higher osmolality enteral tube feed formulation
Promote without fiber	Promote without fiber	Lower osmolality enteral tube feed formulation

Primary Outcome Measures

Name	Time	Method
Incidence of diarrhea at 72 hours	72 hour

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Utah Health; 🇺🇸 Salt Lake City, Utah, United States