A Randomized Controlled Study of Enteral Nutrition in Septic Shock
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|ClinicalTrials.gov Identifier: NCT02025127|
Recruitment Status : Recruiting
First Posted : December 31, 2013
Last Update Posted : August 18, 2017
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 or disease||Intervention/treatment||Phase|
|Septic Shock||Other: Enteral nutrition||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Study of Enteral Nutrition in Septic Shock|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||April 2018|
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.
- Intensive care unit free days [ Time Frame: 28 days ]Number of intensive care unit free days
- 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
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
|Contact: Jayshil J Patel, MDfirstname.lastname@example.org|
|Contact: Jeanette Graf, BS, CCRPemail@example.com|
|United States, Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Contact: Jayshil J Patel, MD 414-955-7040 firstname.lastname@example.org|
|Contact: Jeanette Graf, BS, CCRP 414-955-6987 email@example.com|
|Principal Investigator: Jayshil J Patel, MD|
|Principal Investigator:||Jayshil J Patel, MD||Medical College of Wisconsin|