Incidence of Diarrhea Using High and Low Osmolality Enter... | NCT03487744

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

NCT03487744

Sponsor

University of Utah

Status

Terminated

Last Update Posted

Jul 23, 2019Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Tube Feeding

Interventions

Osmolite 1.5
Promote without fiber

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

slow enrollment

Expanded Access Info

Start Date

Jul 2, 2018Actual

Primary Completion Date

Jun 30, 2019Actual

Completion Date

Jun 30, 2019Actual

First Submitted Date

Mar 20, 2018

First Submission Date that Met QC Criteria

Mar 27, 2018

First Posted Date

Apr 4, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2019

Last Update Posted Date

Jul 23, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Osmolite 1.5	Other	Continuous enteral tube feeding according to a standardized calculation via nasojejunal tube.	Osmolite 1.5

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of diarrhea at 72 hours		72 hour

Secondary Outcomes

Measure	Description	Time Frame
Incidence of diarrhea at 14 days		14 days
Mean frequency of diarrhea days		14 days
Total number of diarrhea days

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Utah Health		Salt Lake City	Utah	84112	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003967	Diarrhea
D016638	Critical Illness

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D020969	Disease Attributes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004043	Dietary Fiber

Ancestor Terms

ID	Term
D004040	Dietary Carbohydrates
D002241	Carbohydrates
D005502	Food
D000066888	Diet, Food, and Nutrition

Browse Leaves

Not provided

Browse Branches

Not provided