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

Tube Feeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03487744
• Other study ID #: IRB_00108798
• Status: Terminated
• Phase: N/A
• Start date: July 2, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: July 2019
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 with a lower osmolality.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Diarrhea
• Tube Feeding

Intervention

Other:
• Osmolite 1.5
Continuous enteral tube feeding according to a standardized calculation via nasojejunal tube.
• Promote without fiber
Continuous enteral tube feeding according to a standardized calculation via nasojejunal tube.

Locations

Country	Name	City	State
United States	University of Utah Health	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of diarrhea at 72 hours		72 hour
Secondary	Incidence of diarrhea at 14 days		14 days
Secondary	Mean frequency of diarrhea days		14 days
Secondary	Total number of diarrhea days		14 days
Secondary	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
Secondary	Time at 75% or more of goal tube feeding rate		14 days
Secondary	Incidence of hypokalemia		14 days
Secondary	Incidence of perineal dermatitis		14 days
Secondary	Number of Clostridium difficile assays sent		14 days