Effect of Location of Feeding on Glycemic Control in Critically Ill Patients (ELF) (ELF)
Primary Purpose
Glucose Metabolism Disorders, Critical Illness
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gastric
Sponsored by
About this trial
This is an interventional treatment trial for Glucose Metabolism Disorders
Eligibility Criteria
Inclusion Criteria:
- Adult (18 years or above) patients admitted in the critical care unit on mechanical ventilation for at least 48 hours
- Orders for tube feeding
Exclusion Criteria:
- Intubated for less than 48 hours (suspected insufficient time for the role of feeding mode to affect glycemic control)
- Patients not being fed (such as DKA, GI bleed, obstruction, ileus, etc)
- Pre-existing PEG/PEJ tubes
- Surgically altered upper and middle GI tract such as partial gastrectomy, gastric bypass surgeries etc. (patients with ileostomy and colostomy may still be included if the enteral route is used for nutrition)
- No informed consent
- Primary attending finds medical necessity to have a specific type of tube preventing randomization
Sites / Locations
- Winchester Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Gastric Tube Placement
Small bowel
Arm Description
Nasoenteric tube placed in the stomach.
Nasoenteric tube placed in the small bowel.
Outcomes
Primary Outcome Measures
Nasoenteric tube placement
Investigate the effect of location of feeding on glycemic control
Secondary Outcome Measures
Full Information
NCT ID
NCT03566992
First Posted
June 12, 2018
Last Updated
June 22, 2018
Sponsor
Winchester Medical Center
Collaborators
Halyard Health
1. Study Identification
Unique Protocol Identification Number
NCT03566992
Brief Title
Effect of Location of Feeding on Glycemic Control in Critically Ill Patients (ELF)
Acronym
ELF
Official Title
Effect of Location of Feeding on Glycemic Control in Critically Ill Patients (ELF)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
July 1, 2018 (Anticipated)
Study Completion Date
September 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Winchester Medical Center
Collaborators
Halyard Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate the effect of location of feeding on glycemic control in critically ill patients.
The investigators hypothesize that glycemic control in critically ill patients who receive enteral nutrition through postpyloric location (beyond stomach) will have better glycemic control compared to critically ill patients fed gastrically.
Detailed Description
Randomization will happen after initial stabilization phase which may last up to 24 hours till when patient may or may not have an enteric access. If enteral access is gained and patient is screened in for the study using inclusion and exclusion criteria, a consent shall be obtained for enrollment. The tube may be continued to be used if randomized in group A. If patient is randomized to group B, a postpyloric placement will be achieved.
Randomization using computer software and a unique identification number will be assigned to every intubated patients who may need mechanical ventilation or tube feed for more than 48 hours.
Randomization will be considered incomplete and the case will be excluded if the process of assigning group, confirmation of placement of appropriate group specific tube and nutrition is not initiated within 24 hours.
If patient is randomized into group A, a bedside RN or the intensivist will place a Salem Sump gastric tube. A nutrition consult for tube feed will be obtained. Confirmation of gastric placement and not a postpyloric placement will be based on the length of the orogastric/nasogastric tube and a standard chest radiograph obtained routinely after intubation. The NG or OG tube should not be more than 65 cm in most cases to prevent it from migrating into the postpyloric location. A standard enteral tube feed formula will be initiated. Blood sugars checked via basic metabolic (at least daily) panel and point-of-care glucose tests (at least every 6 hours) will be obtained. Data collection and Salem Sump placement will be confirmed by the studying team and will not be known to the RD prescribing the nutrition.
If a patient is randomized into group B, a trained RN or RD will place the small-bore feeding feeding tube in the postpyloric position. The effort will be to assure jejunal placement, but postpyloric placement should be sufficient. If for some reason, the small-bore tube cannot be passed beyond pylorus, then sufficient length will be left in IRB the stomach and the case will be noted to have not had the postpyloric placement.
A per protocol analysis and an intention to treat analysis will be carried in the end to take into consideration cases when placement of tube in certain location could not be achieved.
If a feeding tube becomes occluded, it will be replaced with a new tube within 12 hours. If the patient had a postpyloric tube and the new tube cannot be positioned in the postpyloric location, the patient's involvement in the study will be halted (no further data collection).
A standard enteral tube feed formula will be initiated. Blood sugars checked via basic metabolic (at least daily) panel and point-of-care glucose tests (at least every 6 hours) will be obtained.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucose Metabolism Disorders, Critical Illness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
170 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gastric Tube Placement
Arm Type
Active Comparator
Arm Description
Nasoenteric tube placed in the stomach.
Arm Title
Small bowel
Arm Type
Experimental
Arm Description
Nasoenteric tube placed in the small bowel.
Intervention Type
Procedure
Intervention Name(s)
Gastric
Intervention Description
Placement of a nasoenteric tube
Primary Outcome Measure Information:
Title
Nasoenteric tube placement
Description
Investigate the effect of location of feeding on glycemic control
Time Frame
Intubated patients >48 hours and up to 7 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adult (18 years or above) patients admitted in the critical care unit on mechanical ventilation for at least 48 hours
Orders for tube feeding
Exclusion Criteria:
Intubated for less than 48 hours (suspected insufficient time for the role of feeding mode to affect glycemic control)
Patients not being fed (such as DKA, GI bleed, obstruction, ileus, etc)
Pre-existing PEG/PEJ tubes
Surgically altered upper and middle GI tract such as partial gastrectomy, gastric bypass surgeries etc. (patients with ileostomy and colostomy may still be included if the enteral route is used for nutrition)
No informed consent
Primary attending finds medical necessity to have a specific type of tube preventing randomization
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brett Baney, MS, RD
Phone
540-536-1631
Email
bbaney@valleyhealthlink.com
First Name & Middle Initial & Last Name or Official Title & Degree
Susan Lessar, MS, RD
Phone
540-536-1882
Email
slessar@valleyhealthlink.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Padmaraj Duvvuri, MD
Organizational Affiliation
Winchester Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Winchester Medical Center
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22602
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brett Baney, MS, RD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
16484901
Citation
Metheny NA, Clouse RE, Chang YH, Stewart BJ, Oliver DA, Kollef MH. Tracheobronchial aspiration of gastric contents in critically ill tube-fed patients: frequency, outcomes, and risk factors. Crit Care Med. 2006 Apr;34(4):1007-15. doi: 10.1097/01.CCM.0000206106.65220.59.
Results Reference
background
PubMed Identifier
22985684
Citation
Di Bartolomeo AE, Chapman MJ, V Zaknic A, Summers MJ, Jones KL, Nguyen NQ, Rayner CK, Horowitz M, Deane AM. Comparative effects on glucose absorption of intragastric and post-pyloric nutrient delivery in the critically ill. Crit Care. 2012 Sep 17;16(5):R167. doi: 10.1186/cc11522.
Results Reference
background
PubMed Identifier
22480751
Citation
Pournaras DJ, Aasheim ET, Bueter M, Ahmed AR, Welbourn R, Olbers T, le Roux CW. Effect of bypassing the proximal gut on gut hormones involved with glycemic control and weight loss. Surg Obes Relat Dis. 2012 Jul-Aug;8(4):371-4. doi: 10.1016/j.soard.2012.01.021. Epub 2012 Mar 3.
Results Reference
background
PubMed Identifier
26762368
Citation
Luttikhold J, van Norren K, Rijna H, Buijs N, Ankersmit M, Heijboer AC, Gootjes J, Hartmann B, Holst JJ, van Loon LJ, van Leeuwen PA. Jejunal feeding is followed by a greater rise in plasma cholecystokinin, peptide YY, glucagon-like peptide 1, and glucagon-like peptide 2 concentrations compared with gastric feeding in vivo in humans: a randomized trial. Am J Clin Nutr. 2016 Feb;103(2):435-43. doi: 10.3945/ajcn.115.116251. Epub 2016 Jan 13.
Results Reference
background
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Effect of Location of Feeding on Glycemic Control in Critically Ill Patients (ELF)
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