Enteral Nutrition and Vasoactive Drugs

Critical Care Clinical Trial

— NUTRIVAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03401632
• Other study ID #: HSeveroOchoa
• Status: Completed
• Start date: January 15, 2017
• Est. completion date: June 30, 2020

Study information

• Verified date: July 2020
• Source: Hospital Severo Ochoa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 30, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Critical Care
• Enteral Nutrition
• Hemodynamics Instability
• Vasopressor Agents

Intervention

Other:
• Enteral nutrition
Enteral nutrition support

Locations

Country	Name	City	State
Spain	Complejo Hospitalario Universitario A Coruña	A Coruña	Galicia
Spain	Hospital Universitario del Tajo	Aranjuez	Madrid
Spain	Hospital Universitario de Bellvitge	Barcelona	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 de Fuenlabrada	Fuenlabrada	Madrid
Spain	Hospital Universitario de Girona Josep Trueta	Gerona	Cataluña
Spain	Hospital de Barbastro	Huesca	Aragón
Spain	Hospital de San Jorge	Huesca	Aragón
Spain	Hospital Universitario Severo Ochoa	Leganés.	Madrid
Spain	Hospital Universitario Arnau de Villanova	Lérida	Cataluña
Spain	Hospital Universitario Lucus Augusti	Lugo	Galicia
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Clínico San Carlos	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Regional Universitario de Málaga	Málaga	Andalucía
Spain	Hospital General Universitario Reina Sofía	Murcia
Spain	Hospital de Manacor.	Palma De Mallorca	Islas Baleares
Spain	Hospital Universitario Infanta Cristina	Parla	Madrid
Spain	Hospital Universitario Mútua Terrassa	Terrassa	Cataluña
Spain	Hospital Clínico Universitario de Valencia	Valencia	Comunidad Valenciana
Spain	Hospital Universitario Río Hortega	Valladolid	Castilla Y León
Spain	Hospital Universitario Miguel Servet	Zaragoza	Aragón

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Severo Ochoa	Hospital Universitario 12 de Octubre

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	Blood lactate.	Daily peak blood lactate, in mmol/l.	Daily to a maximum of 14 days after Intensive Care Unit Admission.
Secondary	Cardiac index.	Daily lowest cardiac index, in L/min/m^2	Daily to a maximum of 14 days after Intensive Care Unit Admission.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Nasogastric tube complications.	Obstruction or misplacement/accidental extubation.	Daily to a maximum of 14 days after Intensive Care Unit Admission.
Secondary	Enteral nutrition interruptions.	Need to interrupt or discontinue enteral nutrition (and reasons)	Daily to a maximum of 14 days after Intensive Care Unit Admission.