A Randomized Controlled Study of Enteral Nutrition in Septic Shock

Septic Shock Clinical Trial

Official title:

A Randomized Controlled Study of Enteral Nutrition in Septic Shock

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02025127
• Other study ID #: 19966
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: January 2018

Study information

• Verified date: August 2019
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Other:
• Enteral nutrition
Enteral nutrition introduced via a feeding tube

Locations

Country	Name	City	State
United States	Froedtert Hospital	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

References & Publications (7)

Annane D, Bellissant E, Cavaillon JM. Septic shock. Lancet. 2005 Jan 1-7;365(9453):63-78. Review. — View 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. Review. — View Citation

Cresci G, Cúe 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. Review. — View 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. — View 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. Erratum in: Am J Crit Care. 2010 Nov;19(6):488. — View 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. — View Citation

Revelly JP, Tappy L, Berger MM, Gersbach P, Cayeux C, Chioléro 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Ventilator free days	Number of days alive and off mechanical ventilatory support out of 30	30 days
Secondary	Hospital mortality	number of patients who died during hospitalization	30 days
Secondary	intensive care unit free days	number of days alive and out of the intensive care unit out of 30	30 days
Secondary	change in 48 hour sequential organ failure assessment score, with higher score representing worse outcome	absolute change in sequential organ failure assessment score (range 0-24 points) from day 0 to 48 hours, with higher scores representing worse outcomes	48 hours