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

Study Overview
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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.

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

Conditions
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Tube Feeding

Intervention / Treatment
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* Other: Osmolite 1.5
* Other: Promote without fiber


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Promote without fiber<br>Lower osmolality enteral tube feed formulation | Other: Promote without fiber<br>* Continuous enteral tube feeding according to a standardized calculation via nasojejunal tube.<br>|
| Active Comparator: Osmolite 1.5<br>Higher osmolality enteral tube feed formulation | Other: Osmolite 1.5<br>* Continuous enteral tube feeding according to a standardized calculation via nasojejunal tube.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of diarrhea at 72 hours |  | 72 hour | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tube Feeding, Diarrhea, Enteral Nutrition, Critically Ill, Surgical, Cardiovascular