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A Randomized Controlled Study of Enteral Nutrition in Septic Shock

This study is currently recruiting participants.
Verified August 2017 by Jayshil Patel, Medical College of Wisconsin
Sponsor:
ClinicalTrials.gov Identifier:
NCT02025127
First Posted: December 31, 2013
Last Update Posted: August 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Jayshil Patel, Medical College of Wisconsin
  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
Intervention Model: Parallel Assignment
Masking: None (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 Jayshil Patel, Medical College of Wisconsin:

Primary Outcome Measures:
  • Intensive care unit free days [ Time Frame: 28 days ]
    Number of intensive care unit free days


Secondary Outcome Measures:
  • Ventilator free days [ Time Frame: 28 days ]
    Number of ventilator free days

  • Mortality [ Time Frame: 30 days ]
  • Time to 50% reduction in vasopressors [ Time Frame: 30 days ]
    Determination of the time in days to 50% reduction of the maximal vasopressor dose

  • Initiation of physical therapy [ Time Frame: 30 days ]
    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: April 2018
Estimated Primary Completion Date: April 2018 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02025127


Contacts
Contact: Jayshil J Patel, MD 414-955-7040 jpatel2@mcw.edu
Contact: Jeanette Graf, BS, CCRP 414-955-6987 jgraf@mcw.edu

Locations
United States, Wisconsin
Froedtert Hospital Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Jayshil J Patel, MD    414-955-7040    jpatel2@mcw.edu   
Contact: Jeanette Graf, BS, CCRP    414-955-6987    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 Patel, Principle Investigator, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT02025127     History of Changes
Other Study ID Numbers: 19966
First Submitted: December 17, 2013
First Posted: December 31, 2013
Last Update Posted: August 18, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jayshil Patel, 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