A Randomized Controlled of Enteral Nutrition in Septic Shock

This study is currently recruiting participants.
Verified March 2014 by Medical College of Wisconsin
Sponsor:
Information provided by (Responsible Party):
Jayshil Patal, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT02025127
First received: December 17, 2013
Last updated: March 11, 2014
Last verified: March 2014
  Purpose

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.

There is a paucity of data on the timing and role of enteral nutrition in septic shock.

Specific aim 1: To examine the effect of enteral nutrition of >50 kcal/day but <600 kcal/day compared to no enteral nutrition initiated with 24 hours of admission on the number of intensive care unit free days' in patients with septic shock.

Hypothesis 1: The investigators hypothesize that amongst mechanically ventilated patients with a diagnosis of septic shock, the initiation of early enteral nutrition of >50 kcal/day but <600 kcal/day, as compared to no enteral nutrition, improves the primary outcome of number of intensive care unit free days'.

Specific aim 2: To examine the effect of enteral nutrition of >50 kcal/day but< 600 kcal/day initiated with 24 hours of admission on in-hospital mortality, mechanical ventilator free days, time to 50% reduction in vasopressor dose, and time to initiation of physical therapy in patients with septic shock.

Hypothesis 2: The investigators hypothesize that amongst mechanically ventilated patients with a diagnosis of septic shock, the initiation of early enteral nutrition of >50 kcal/day but <600 kcal/day, as compared to no enteral nutrition, decreases mortality, duration of mechanical ventilation, time to 50% reduction in vasopressor dose, and time to initiation of physical therapy.


Condition Intervention
Septic Shock
Other: Enteral nutrition

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Study of Enteral Nutrition in Septic Shock

Resource links provided by NLM:


Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • Intensive care unit free days [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Number of intensive care unit free days


Secondary Outcome Measures:
  • Ventilator free days [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Number of ventilator free days

  • Mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Time to 50% reduction in vasopressors [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Determination of the time in days to 50% reduction of the maximal vasopressor dose

  • Initiation of physical therapy [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Time in days to initiation of physical therapy from intensive care unit admission


Estimated Enrollment: 64
Study Start Date: January 2014
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Trophic feeding
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
Enteral nutrition introduced via a feeding tube
No Intervention: No Enteral Nutrition
Mechanically ventilated patients with septic shock randomized to this group will receive no enteral nutrition while on vasopressor support.

Detailed Description:

See above

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02025127

Contacts
Contact: Jayshil J Patel, MD 414-955-7042 jpatel2@mcw.edu
Contact: Jeanette Graf 414-955-7042 jgraf@mcw.edu

Locations
United States, Wisconsin
Froedtert Hospital Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Jayshil J Patel, MD    414-955-7042    jpatel2@mcw.edu   
Contact: Jeanette Graf    414-955-7042    jgraf@mcw.edu   
Principal Investigator: Jayshil J Patel, MD         
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
Principal Investigator: Jayshil J Patel, MD Medical College of Wisconsin
  More Information

Publications:

Responsible Party: Jayshil Patal, Principle investigator, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT02025127     History of Changes
Other Study ID Numbers: 19966
Study First Received: December 17, 2013
Last Updated: March 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:
septic shock
mechanical ventilation
enteral nutrition
trophic feeding

Additional relevant MeSH terms:
Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation

ClinicalTrials.gov processed this record on April 20, 2014