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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03487744
Recruitment Status : Terminated (slow enrollment)
First Posted : April 4, 2018
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Amanda Zomp, University of Utah

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.

Condition or disease Intervention/treatment Phase
Tube Feeding Other: Osmolite 1.5 Other: Promote without fiber Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Comparison of the Incidence of Diarrhea Using High and Low Osmolality Enteral Tube Feeding in Critically Ill Surgical Patients
Actual Study Start Date : July 2, 2018
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arm Intervention/treatment
Active Comparator: Promote without fiber
Lower osmolality enteral tube feed formulation
Other: Promote without fiber
Continuous enteral tube feeding according to a standardized calculation via nasojejunal tube.

Active Comparator: Osmolite 1.5
Higher osmolality enteral tube feed formulation
Other: Osmolite 1.5
Continuous enteral tube feeding according to a standardized calculation via nasojejunal tube.




Primary Outcome Measures :
  1. Incidence of diarrhea at 72 hours [ Time Frame: 72 hour ]

Secondary Outcome Measures :
  1. Incidence of diarrhea at 14 days [ Time Frame: 14 days ]
  2. Mean frequency of diarrhea days [ Time Frame: 14 days ]
  3. Total number of diarrhea days [ Time Frame: 14 days ]
  4. Mean diarrhea scores [ Time Frame: 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)

  5. Time at 75% or more of goal tube feeding rate [ Time Frame: 14 days ]
  6. Incidence of hypokalemia [ Time Frame: 14 days ]
  7. Incidence of perineal dermatitis [ Time Frame: 14 days ]
  8. Number of Clostridium difficile assays sent [ Time Frame: 14 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03487744


Locations
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United States, Utah
University of Utah Health
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah

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Responsible Party: Amanda Zomp, Clinical Pharmacist, University of Utah
ClinicalTrials.gov Identifier: NCT03487744    
Other Study ID Numbers: IRB_00108798
First Posted: April 4, 2018    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Amanda Zomp, University of Utah:
Tube Feeding
Diarrhea
Enteral Nutrition
Critically Ill
Surgical
Cardiovascular
Additional relevant MeSH terms:
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Critical Illness
Diarrhea
Disease Attributes
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms