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Enteral Nutrition and Vasoactive Drugs

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03401632
Acronym
NUTRIVAD
Enrollment
200
Registered
2018-01-17
Start date
2017-01-15
Completion date
2020-06-30
Last updated
2020-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Care, Enteral Nutrition, Hemodynamics Instability, Vasopressor Agents

Keywords

Enteral nutrition, Vasoactive Drugs, Critical Care

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.

Interventions

OTHEREnteral nutrition

Enteral nutrition support

Sponsors

Hospital Universitario 12 de Octubre
CollaboratorOTHER
Hospital Severo Ochoa
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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.
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.

Secondary

MeasureTime frameDescription
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.
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.
High gastric residual volume.Daily to a maximum of 14 days after Intensive Care Unit AdmissionGastric residual volume was described as high when \>500 mL was obtained in each assessment.
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
Blood lactate.Daily to a maximum of 14 days after Intensive Care Unit Admission.Daily peak blood lactate, in mmol/l.
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.
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.
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)
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.
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).

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026