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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03487744

Enrollment

Registered

2018-04-04

Start date

2018-07-02

Completion date

2019-06-30

Last updated

2019-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tube Feeding

Keywords

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

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.

Interventions

OTHEROsmolite 1.5

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

OTHERPromote without fiber

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Incidence of diarrhea at 72 hours	72 hour

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026