NCT02025127

Brief Summary

There is a paucity of data on the timing and role of enteral nutrition in septic shock. The primary aim of this study is to conduct a phase III single-center pilot randomized controlled trial comparing early trophic enteral nutrition to 'no enteral nutrition' in mechanically ventilated septic shock patients to determine feasibility.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

December 17, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 31, 2013

Completed
1 day until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

August 16, 2019

Status Verified

August 1, 2019

Enrollment Period

4 years

First QC Date

December 17, 2013

Last Update Submit

August 13, 2019

Conditions

Septic Shock

Keywords

septic shockmechanical ventilationenteral nutritiontrophic feeding

Outcome Measures

Primary Outcomes (1)

  • number of patients consenting to study and remaining compliant with assigned study arm

    consent and compliance rate of \>75% and contamination rate \<10%

    46 months

Secondary Outcomes (4)

  • Ventilator free days

    30 days

  • Hospital mortality

    30 days

  • intensive care unit free days

    30 days

  • change in 48 hour sequential organ failure assessment score, with higher score representing worse outcome

    48 hours

Study Arms (2)

Trophic feeding

EXPERIMENTAL

Mechanically ventilated patients with septic shock \> 18 years old randomized to this group will receive more than 50 but less than 600 kilocalories of enteral nutrition per day while on vasopressors. This will be started within 24 hours of intensive care unit admission.

Other: Enteral nutrition

No Enteral Nutrition

NO INTERVENTION

Mechanically ventilated patients with septic shock randomized to this group will receive no enteral nutrition while on vasopressor support.

Interventions

Enteral nutritionOTHER

Enteral nutrition introduced via a feeding tube

Trophic feeding

Eligibility Criteria

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

You may qualify if:

  • Adults greater than or equal to 18 years old
  • Clinical diagnosis of septic shock
  • Mechanically ventilation anticipated for at least 48 hours

You may not qualify if:

  • Do not resuscitate order
  • Not able to obtain consent
  • Those not able to be randomized within 18 hours
  • Those with small bowel ischemia or obstruction
  • Protracted ileus, intractable vomiting, major gastrointestinal bleeding defined as needing 2 or more units of packed red cells, and any bowel surgery within the previous 30 days prior to intensive care unit admission
  • Those with a contraindication for placement of a feeding tube

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (7)

  • Annane D, Bellissant E, Cavaillon JM. Septic shock. Lancet. 2005 Jan 1-7;365(9453):63-78. doi: 10.1016/S0140-6736(04)17667-8.

    PMID: 15639681BACKGROUND

  • Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, Sevransky JE, Sprung CL, Douglas IS, Jaeschke R, Osborn TM, Nunnally ME, Townsend SR, Reinhart K, Kleinpell RM, Angus DC, Deutschman CS, Machado FR, Rubenfeld GD, Webb S, Beale RJ, Vincent JL, Moreno R; Surviving Sepsis Campaign Guidelines Committee including The Pediatric Subgroup. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock, 2012. Intensive Care Med. 2013 Feb;39(2):165-228. doi: 10.1007/s00134-012-2769-8. Epub 2013 Jan 30.

    PMID: 23361625BACKGROUND

  • McClave SA, Martindale RG, Vanek VW, McCarthy M, Roberts P, Taylor B, Ochoa JB, Napolitano L, Cresci G; A.S.P.E.N. Board of Directors; American College of Critical Care Medicine; Society of Critical Care Medicine. Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient: Society of Critical Care Medicine (SCCM) and American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.). JPEN J Parenter Enteral Nutr. 2009 May-Jun;33(3):277-316. doi: 10.1177/0148607109335234. No abstract available.

    PMID: 19398613BACKGROUND

  • Cresci G, Cue J. The patient with circulatory shock: to feed or not to feed? Nutr Clin Pract. 2008 Oct-Nov;23(5):501-9. doi: 10.1177/0884533608323431.

    PMID: 18849555BACKGROUND

  • Revelly JP, Tappy L, Berger MM, Gersbach P, Cayeux C, Chiolero R. Early metabolic and splanchnic responses to enteral nutrition in postoperative cardiac surgery patients with circulatory compromise. Intensive Care Med. 2001 Mar;27(3):540-7. doi: 10.1007/s001340100855.

    PMID: 11355123BACKGROUND

  • Khalid I, Doshi P, DiGiovine B. Early enteral nutrition and outcomes of critically ill patients treated with vasopressors and mechanical ventilation. Am J Crit Care. 2010 May;19(3):261-8. doi: 10.4037/ajcc2010197.

    PMID: 20436064BACKGROUND

  • Bone RC, Balk RA, Cerra FB, Dellinger RP, Fein AM, Knaus WA, Schein RM, Sibbald WJ. Definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. The ACCP/SCCM Consensus Conference Committee. American College of Chest Physicians/Society of Critical Care Medicine. Chest. 1992 Jun;101(6):1644-55. doi: 10.1378/chest.101.6.1644.

    PMID: 1303622BACKGROUND

MeSH Terms

Conditions

Shock, Septic

Interventions

Enteral Nutrition

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Study Officials

  • Jayshil J Patel, MD

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

December 17, 2013

First Posted

December 31, 2013

Study Start

January 1, 2014

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

August 16, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)