Enteral Nutrition in Critically Ill Patients Undergoing Vasoactive Drugs Therapy. The NUTRIVAD Study.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Enteral Nutrition
- Sponsor
- Hospital Severo Ochoa
- Enrollment
- 200
- Locations
- 23
- Primary Endpoint
- Enteral nutrition-related mesenteric ischemia.
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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
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.
Investigators
Jose Luis Flordelis Lasierra, MD, PhD
Principal Investigator
Hospital Severo Ochoa
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Enteral nutrition-related mesenteric ischemia.
Time Frame: Daily to a maximum of 14 days after Intensive Care Unit Admission.
Main enteral nutrition- safety related variable, suspected by the presence of warning signs (clinical, analytical, radiological), confirmed by laparotomy/laparoscopy, arteriography or angio-CT.
Dose of vasoactive drugs.
Time Frame: Daily to a maximum of 14 days after Intensive Care Unit Admission.
Dose of vasoactive drugs (highest daily), in μg/kg/min.
Kilocalories delivered by enteral route and Energy balance (Kilocalories delivered by enteral nutrition - (minus) enteral nutrition target in Kilocalories).
Time Frame: Daily to a maximum of 14 days after Intensive Care Unit Admission.
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.
Secondary Outcomes
- Abdominal distention.(Daily to a maximum of 14 days after Intensive Care Unit Admission.)
- Regurgitation.(Daily to a maximum of 14 days after Intensive Care Unit Admission.)
- Nasogastric tube complications.(Daily to a maximum of 14 days after Intensive Care Unit Admission.)
- Enteral nutrition interruptions.(Daily to a maximum of 14 days after Intensive Care Unit Admission.)
- Nutrition Tolerance.(Daily to a maximum of 14 days after Intensive Care Unit Admission.)
- High gastric residual volume.(Daily to a maximum of 14 days after Intensive Care Unit Admission)
- Constipation.(Daily to a maximum of 14 days after Intensive Care Unit Admission.)
- Bronchoaspiration.(Daily to a maximum of 14 days after Intensive Care Unit Admission.)
- Blood lactate.(Daily to a maximum of 14 days after Intensive Care Unit Admission.)
- Cardiac index.(Daily to a maximum of 14 days after Intensive Care Unit Admission.)
- Mechanical circulatory support.(Daily to a maximum of 14 days after Intensive Care Unit Admission.)
- Enteral nutrition-related diarrhea.(Daily to a maximum of 14 days after Intensive Care Unit Admission.)
- Time from Intensive Care Unit admission to the start of enteral nutrition.(Up to 120 hours after Intensive Care Unit Admission.)