"Efficacy of Intermittent Enteral Nutrition Versus Continuous Administration in Intensive Care"

Not Applicable

Recruiting

• Conditions: Gastric Feeding Tube; Feeding Methods; Enteral Nutrition; Critical Care
• Interventions: Other: CONTINUOS ENTERAL NUTRITITION (CEN); Other: INTERMITTENT ENTERAL NUTRITITION (IEN)

• Registration Number: NCT05879263
• Lead Sponsor: Complejo Hospitalario Universitario de Albacete

Brief Summary

The goal of this clinical trial is to Determine efficacy of intermittent enteral nutrition vs continuous enteral nutrition in adults patients with a nasogastric tube in a intensive care unit.

The main question\[s\] it aims to answer are:

* Reduction of gastrointestinal and respiratory complications

* Evaluate the achievement of the caloric objective Informed consent will be requested from participants who meet the inclusion criteria.

The participants will be randomized into two groups: control group (continuous enteral nutrition) or experimental group (intermittent enteral nutrition) Researchers will compare intermittent enteral nutrition vs continuous to see if there is a reduction in gastrointestinal and respiratory complications.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-10
• Status Verified: 2023-05
• Study First Submitted: 2023-05-03
• Study First Submitted QC: 2023-05-25
• Last Update Submitted: 2023-05-25
• Study First Posted: 2023-05-30
• Last Update Posted: 2023-05-30
• Primary Completion: 2024-02-29
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

• Patients admitted to ICU of University General Hospital of Albacete
• Need for enteral nutrition by nasogastric tube in the first 48 hours
• Signed informed consent

Exclusion Criteria

• Insulin dependent diabetic patients
• Abdominal surgery
• Dire prognosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CONTINUOUS ENTERAL NUTRITION (CEN)	CONTINUOS ENTERAL NUTRITITION (CEN)	Administration of Enteral Nutriton (EN) by nasogastric tube during 24 hours, using an infusion pump.
INTERMITTENT ENTERAL NUTRITITION (IEN)	INTERMITTENT ENTERAL NUTRITITION (IEN)	Administration of Enteral Nutriton (EN) by nasogastric tube in 4 bolus (24h): Duration of the infusion 1hour each shot, using an infusion pump.

Primary Outcome Measures

Name	Time	Method
Respiratory Complications	during ICU stay (maximum 15 days)	Respiratory aspiration of gastric content
Gastrointestinal Complications	during ICU stay (maximum 15 days)	Digestive intolerance: Diarrhea, vomiting, increased gastric residual volume(GRV)

Secondary Outcome Measures

Name	Time	Method
Achievement of the caloric objective	during ICU stay (up to 15 days)	Time in hours to reach caloric goal
Nutritional status: MNA	up to two days after admission to the ICU	Measure with:Mini Nutritional Assessment,(MNA) 12-14 points: Normal nutritional status 8-11 points: risk of malnutrition 0-7 points: Malnutrition
ICU Stay	From date of randomization until 100 months	Days of stay in ICU
Nutritional status: Biochemical values	up to two days after admission to the ICU	Measure with:biochemical values: albumin, prealbumin, total protein
Changes in blood glucose	during ICU stay (maximum 15 days)	Episodes of hypoglycemia or hyperglycemia
Mortality	until the date of death from any cause until 100 months	Percentage of deaths in ICU
Change of type of EN administration	during ICU stay (maximum 15 days)	Change of EN administration modality
Nutritional status:Glim Criteria	up to two days after admission to the ICU	Measure with: Glim criteria: Phenotypic criteria:Non-volitional weight loss (%) Low BMI (kg/m2)Reduced muscle mass(calf circumference (cm)) Etiologic criteria: Reduced food intake or assimilation. Inflammation; \*Requires at least one phenotypic criterion and one etiologic criterion for the diagnosis of malnutrition

Trial Locations

Locations (1)

Maria Dolores Saiz Vinuesa; 🇪🇸 Albacete, Spain