NCT03566992

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 25, 2018

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

June 26, 2018

Status Verified

June 1, 2018

Enrollment Period

1.2 years

First QC Date

June 12, 2018

Last Update Submit

June 22, 2018

Conditions

Glucose Metabolism DisordersCritical Illness

Outcome Measures

Primary Outcomes (1)

  • Nasoenteric tube placement

    Investigate the effect of location of feeding on glycemic control

    Intubated patients >48 hours and up to 7 days.

Study Arms (2)

Gastric Tube Placement

ACTIVE COMPARATOR

Nasoenteric tube placed in the stomach.

Procedure: Gastric

Small bowel

EXPERIMENTAL

Nasoenteric tube placed in the small bowel.

Procedure: Gastric

Interventions

GastricPROCEDURE

Placement of a nasoenteric tube

Gastric Tube PlacementSmall bowel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult (18 years or above) patients admitted in the critical care unit on mechanical ventilation for at least 48 hours
  • Orders for tube feeding

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Winchester Medical Center

Winchester, Virginia, 22602, United States

RECRUITING

Related Publications (4)

  • 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.

    PMID: 16484901BACKGROUND

  • 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.

    PMID: 22985684BACKGROUND

  • 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.

    PMID: 22480751BACKGROUND

  • 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.

    PMID: 26762368BACKGROUND

MeSH Terms

Conditions

Glucose Metabolism DisordersCritical Illness

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Padmaraj Duvvuri, MD

    Winchester Medical Center

    STUDY DIRECTOR

Central Study Contacts

Brett Baney, MS, RD

CONTACT

540-536-1631bbaney@valleyhealthlink.com

Susan Lessar, MS, RD

CONTACT

540-536-1882slessar@valleyhealthlink.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Critical Care Physician

Study Record Dates

First Submitted

June 12, 2018

First Posted

June 25, 2018

Study Start

May 1, 2017

Primary Completion

July 1, 2018

Study Completion

September 1, 2018

Last Updated

June 26, 2018

Record last verified: 2018-06

Locations

US(1)