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

Utah System of Higher Education (USHE)

Status: Terminated

Conditions: Tube Feeding

Treatments: Other: Promote without fiber; Other: Osmolite 1.5

Study type: Interventional

Funder types: Other

Identifiers

NCT03487744

IRB_00108798

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Promote without fiber

Active Comparator group

Description:

Lower osmolality enteral tube feed formulation

Treatment:

Other: Promote without fiber

Osmolite 1.5

Active Comparator group

Description:

Higher osmolality enteral tube feed formulation

Treatment:

Other: Osmolite 1.5