Evaluation of the Efficiency of Intermittent Enteral Nutrition on Multi-organ Failure From Patients With Mechanical Ventilation in Intensive Care Unit

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Rouen

About this trial

This study aims to evaluate the efficiency of intermittent enteral nutrition versus continuous enteral nutrition to prevent from organ failures for patients at the acute phase of sepsis shock with mechanical ventilation in ICU.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient admitted in ICU for less than 48h, with invasive mechanical ventilation predicted for at least 48h, that can undergo nasogastric feeding for 7 days.

Patient under vasopressive drugs

Adult patients (age ≥ 18 years)

Informed person who has read and signed their consent

Disqualifiers

Contraindication to enteral nutrition and/or nasogastric tube insertion: esophageal varices and occlusive syndrome

Artificial enteral nutrition that cannot be initiated within 48 hours of intubation

Enteral nutrition ongoing for more than one hour at the time of inclusion

Need for exclusive or supplemental parenteral nutrition

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intermittent enteral nutrition

    Other intervention

    Patients will receive intermittent enteral nutrition, defined as 3 60-minute administrations every 8 hours.

Treatment groups

174 Participants
are divided into 2 treatment groups
Group A: Intermittent enteral nutritionExperimental treatment 1 intervention
Group B: continuous enteral nutritionNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Evolution of variation of the SOFA (Sepsis-related organ failure assessment) score.

Comparison of variation of the SOFA score between patients with intermittent nutrition versus patients with continuous nutrition.

Time frame
day-1 (nutrition start) and day-7

Secondary outcomes

1

evaluation of caloric intake

evaluation of caloric intake (kcal/day)

Time frame
from day-1 (nutrition start) to day-7
2

evaluation of protein intake

evaluation of protein intake (g/kg/day)

Time frame
from day-1 (nutrition start) to day-7
3

Measurement of nutritionnal status

measurement of weight (kg)

Time frame
day-1 (nutrition start) and day-7
4

Evaluation of the digestive tolerance

Number of vomit (number)

Time frame
from day-1 (nutrition start) to day-7

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Rouen

Lead sponsor

University Hospital, Lille

Collaborator

University Hospital, Caen

Collaborator

Amiens University Hospital

Collaborator

Centre Hospitalier Saint-Philibert, GHICL

Collaborator

Centre Hospitalier Intercommunal Elbeuf-Louviers-Val de Reuil

Collaborator

Groupe Hospitalier du Havre

Collaborator

Centre Hospitalier de Dieppe

Collaborator