Enteral Nutrition and Vasoactive Drugs

Study Overview
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Brief Summary
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Enteral nutrition in critically ill patients undergoing vasoactive support due to hemodynamic instability is controversial. Hypothesis: enteral nutrition delivered in such patients can be feasible and safe.

Detailed Description
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Nutrition support in critically ill patients undergoing vasoactive support due to hemodynamic instability is controversial and challenging. However, if it is delivered according to an enteral nutrition protocol and under proper medical supervision, it can be feasible and safe. The present multicenter prospective study was designed to examine the feasibility and safety of enteral nutrition support in such patients.

Official Title
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Enteral Nutrition in Critically Ill Patients Undergoing Vasoactive Drugs Therapy. The NUTRIVAD Study.

Conditions
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Enteral Nutrition, Vasopressor Agents, Hemodynamics Instability, Critical Care

Intervention / Treatment
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* Other: Enteral nutrition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Authorization to participate in the study by informed consent. Dependence of vasoactive drugs and/or mechanical circulatory support to at least 48 hours from Intensive Care Unit admission. Invasive mechanical ventilation time of at least 48 hours. Expected survival greater than 72 hours. ICU Stay greater than or equal to 72 hours. Exclusion Criteria: Refusal to participate in the study. Refractory shock, defined as the progressive elevation of the dose of vasoactive drugs and / or markers of tissue hypoperfusion, or mean arterial pressure ≤ 60 mm Hg despite the therapeutic maneuvers. History of significant abdominal vascular disease (ischemic colitis, chronic mesenteric ischemia, aortic aneurysm abdominal, aortic dissection with involvement of mesenteric vessels, etc). Absolute contraindication for the onset of enteral nutrition (active gastrointestinal hemorrhage, intestinal obstruction, etc.) or patients with a non-functional gastrointestinal tract.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Enteral nutrition|Enteral nutrition support|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose of vasoactive drugs. | Dose of vasoactive drugs (highest daily), in μg/kg/min. | Daily to a maximum of 14 days after Intensive Care Unit Admission. | 
| Kilocalories delivered by enteral route and Energy balance (Kilocalories delivered by enteral nutrition - (minus) enteral nutrition target in Kilocalories). | Main Enteral nutrition efficacy-related variables. Enteral nutrition target was 25 Kilocalories/Kg, if body mass index (BMI) was between 20 and 30. Corrections were made if BMI was under 20/ or over 30. | Daily to a maximum of 14 days after Intensive Care Unit Admission. | 
| Enteral nutrition-related mesenteric ischemia. | Main enteral nutrition- safety related variable, suspected by the presence of warning signs (clinical, analytical, radiological), confirmed by laparotomy/laparoscopy, arteriography or angio-CT. | Daily to a maximum of 14 days after Intensive Care Unit Admission. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood lactate. | Daily peak blood lactate, in mmol/l. | Daily to a maximum of 14 days after Intensive Care Unit Admission. | 
| Cardiac index. | Daily lowest cardiac index, in L/min/m^2 | Daily to a maximum of 14 days after Intensive Care Unit Admission. | 
| Mechanical circulatory support. | Dependence on Mechanical circulatory support (intra-aortic balloon pump, mechanical circulatory assistance, or extracorporeal membrane oxygenation). | Daily to a maximum of 14 days after Intensive Care Unit Admission. | 
| Time from Intensive Care Unit admission to the start of enteral nutrition. | Time frame in hours from Intensive Care Unit admission to the start of enteral nutrition. | Up to 120 hours after Intensive Care Unit Admission. | 
| Nutrition Tolerance. | Kilocalories delivered by enteral nutrition, divided by nutrition target in Kilocalories, expressed as percentage. | Daily to a maximum of 14 days after Intensive Care Unit Admission. | 
| High gastric residual volume. | Gastric residual volume was described as high when >500 mL was obtained in each assessment. | Daily to a maximum of 14 days after Intensive Care Unit Admission | 
| Abdominal distention. | A change in the abdomen detected in a physical examination, with an increase in abdominal cavity size relative to that recorded in the pre-enteral nutrition examination | Daily to a maximum of 14 days after Intensive Care Unit Admission. | 
| Regurgitation. | Presence of Enteral nutrition feed in the oral cavity or oropharynx, as well as its spontaneous drainage by the oral and/or nasal route | Daily to a maximum of 14 days after Intensive Care Unit Admission. | 
| Enteral nutrition-related diarrhea. | 5 or more liquid stools in 24 hours or more than two 1000-mL stool volumes, each deposited over a 24-hour period. | Daily to a maximum of 14 days after Intensive Care Unit Admission. | 
| Constipation. | Lack of bowel movements in 7 days from the onset of enteral nutrition or for 3 days in the first week of admission. | Daily to a maximum of 14 days after Intensive Care Unit Admission. | 
| Bronchoaspiration. | The presence of respiratory secretions of similar characteristics to the prescribed enteral nutrition feed, confirmed by the glucose-oxidase technique in tracheal secretion. | Daily to a maximum of 14 days after Intensive Care Unit Admission. | 
| Nasogastric tube complications. | Obstruction or misplacement/accidental extubation. | Daily to a maximum of 14 days after Intensive Care Unit Admission. | 
| Enteral nutrition interruptions. | Need to interrupt or discontinue enteral nutrition (and reasons) | Daily to a maximum of 14 days after Intensive Care Unit Admission. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Enteral nutrition, Vasoactive Drugs, Critical Care