Clinical trial NCT02025127: A Randomized Controlled Study of Enteral Nutrition in Septic Shock
Official title: A Randomized Controlled Study of Enteral Nutrition in Septic Shock
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Septic Shock
Keywords: septic shock
mechanical ventilation
enteral nutrition
trophic feeding
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2013-12-31
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Septic shock represents the body's dysregulated response to an infection, manifesting as persistent hypotension (mean arterial pressure \< 70 mmHg) despite intravenous (IV) fluid resuscitation. Severe sepsis and septic shock are major healthcare problems, affecting millions of people around the world each year In critically ill patients without shock, provision of enteral nutrition within 24-48 hours has shown to preserve intestinal epithelium, maintain brush border enzyme activity, maintenance of barrier function to enhance immune function, and preservation of tight cell junctions to reduce permeability. These benefits of enteral nutrition are postulated to prevent downstream complications of nosocomial infections and the multiple organ dysfunction syndrome (MODS), though direct data addressing this question are lacking.

The primary aim of this study is to conduct a phase III single-center pilot randomized controlled trial comparing early trophic EN to 'no EN' in mechanically ventilated septic shock patients to determine feasibility of achieving \>75% consent and compliance rate and \<10% contamination rate.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: number of patients consenting to study and remaining compliant with assigned study arm
timeFrame: 46 months
Secondary outcomes:
measure: Ventilator free days
timeFrame: 30 days
measure: Hospital mortality
timeFrame: 30 days
measure: intensive care unit free days
timeFrame: 30 days
measure: change in 48 hour sequential organ failure assessment score, with higher score representing worse outcome
timeFrame: 48 hours
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Froedtert Hospital
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Jayshil J Patel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.