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

NCT03487744 | Terminated

• 1 other identifier: IRB_00108798
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Tube Feeding

Keywords

Tube Feeding; Diarrhea; Enteral Nutrition; Critically Ill; Surgical; Cardiovascular

Outcome Measures

Primary Outcomes (1)

• Incidence of diarrhea at 72 hours

  72 hour

Secondary Outcomes (8)

• 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

  14 days

• Time at 75% or more of goal tube feeding rate

  14 days

Study Arms (2)

Promote without fiber

ACTIVE COMPARATOR

Lower osmolality enteral tube feed formulation

Other: Promote without fiber

Osmolite 1.5

ACTIVE COMPARATOR

Higher osmolality enteral tube feed formulation

Other: Osmolite 1.5

Interventions

Osmolite 1.5 OTHER

Continuous enteral tube feeding according to a standardized calculation via nasojejunal tube.

Osmolite 1.5

Promote without fiber OTHER

Continuous enteral tube feeding according to a standardized calculation via nasojejunal tube.

Promote without fiber

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Health

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Diarrhea; Critical Illness

Interventions

Dietary Fiber

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Dietary Carbohydrates; Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Pharmacist

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: April 4, 2018
• Study Start: July 2, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: July 23, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)