Enteral Nutrition and Vasoactive Drugs

Completed

• Conditions: Vasopressor Agents; Critical Care; Enteral Nutrition; Hemodynamics Instability

• Registration Number: NCT03401632
• Lead Sponsor: Hospital Severo Ochoa

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.

Study Timeline

• Study Start: 2017-01-15
• Study First Submitted: 2018-01-03
• Study First Submitted QC: 2018-01-16
• Study First Posted: 2018-01-17
• Primary Completion: 2020-03-01
• Study Completion: 2020-06-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-27
• Last Update Posted: 2020-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Enteral nutrition-related mesenteric ischemia.	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.	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).	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 Outcome Measures

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

Trial Locations

Locations (23)

Hospital Regional Universitario de Málaga; 🇪🇸 Málaga, Andalucía, Spain

Hospital de Barbastro; 🇪🇸 Huesca, Aragón, Spain

Hospital de San Jorge; 🇪🇸 Huesca, Aragón, Spain

Hospital Universitario Miguel Servet; 🇪🇸 Zaragoza, Aragón, Spain

Hospital Universitario Río Hortega; 🇪🇸 Valladolid, Castilla Y León, Spain

Hospital Universitario de Bellvitge; 🇪🇸 Barcelona, Cataluña, Spain

Hospital Universitario de Girona Josep Trueta; 🇪🇸 Gerona, Cataluña, Spain

Hospital Universitario Arnau de Villanova; 🇪🇸 Lérida, Cataluña, Spain

Hospital Universitario Germans Trias i Pujol; 🇪🇸 Barcelona, Cataluña, Spain

Hospital General Universitario de Castellón; 🇪🇸 Castelló de la Plana, Comunidad Valenciana, Spain

Hospital Universitario Mútua Terrassa; 🇪🇸 Terrassa, Cataluña, Spain

Hospital Universitario Lucus Augusti; 🇪🇸 Lugo, Galicia, Spain

Hospital Universitario del Tajo; 🇪🇸 Aranjuez, Madrid, Spain

Hospital Universitario de Fuenlabrada; 🇪🇸 Fuenlabrada, Madrid, Spain

Hospital Universitario Severo Ochoa; 🇪🇸 Leganés., Madrid, Spain

Hospital Universitario Infanta Cristina; 🇪🇸 Parla, Madrid, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Universitario Clínico San Carlos; 🇪🇸 Madrid, Spain

Hospital General Universitario Reina Sofía; 🇪🇸 Murcia, Spain

Hospital de Manacor.; 🇪🇸 Palma De Mallorca, Islas Baleares, Spain

Hospital Clínico Universitario de Valencia; 🇪🇸 Valencia, Comunidad Valenciana, Spain

Complejo Hospitalario Universitario A Coruña; 🇪🇸 A Coruña, Galicia, Spain