Efficacy of Intermittent Enteral Nutrition Versus Continuous Administration in Intensive Care

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Intermittent Enteral Nutrition Versus Continuous Administration in Intensive Care Patients for the Reduction of Complications. Randomized Clinical Trial

Conditions
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Enteral Nutrition, Critical Care, Feeding Methods, Gastric Feeding Tube

Intervention / Treatment
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* Other: INTERMITTENT ENTERAL NUTRITITION (IEN)
* Other: CONTINUOS ENTERAL NUTRITITION (CEN)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The patients wil be allocated to expriemental group or control group using a simple randomization sequence. There is an allocation concealment using sealed opaque envelopes Duration: From February 2022 to complete sample number.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INTERMITTENT ENTERAL NUTRITITION (IEN)<br>Administration of Enteral Nutriton (EN) by nasogastric tube in 4 bolus (24h): Duration of the infusion 1hour each shot, using an infusion pump. | Other: INTERMITTENT ENTERAL NUTRITITION (IEN)<br>* Administration of Enteral Nutriton (EN) by nasogastric tube in 4 bolus (24h): Duration of the infusion 1hour each shot, using an infusion pump.<br>|
| Active Comparator: CONTINUOUS ENTERAL NUTRITION (CEN)<br>Administration of Enteral Nutriton (EN) by nasogastric tube during 24 hours, using an infusion pump. | Other: CONTINUOS ENTERAL NUTRITITION (CEN)<br>* Administration of Enteral Nutriton (EN) by nasogastric tube during 24 hours, using an infusion pump.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory Complications | Respiratory aspiration of gastric content | during ICU stay (maximum 15 days) | 
| Gastrointestinal Complications | Digestive intolerance: Diarrhea, vomiting, increased gastric residual volume(GRV) | during ICU stay (maximum 15 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of the caloric objective | Time in hours to reach caloric goal | during ICU stay (up to 15 days) | 
| Nutritional status: MNA | Measure with:Mini Nutritional Assessment,(MNA) 12-14 points: Normal nutritional status 8-11 points: risk of malnutrition 0-7 points: Malnutrition | up to two days after admission to the ICU | 
| Changes in blood glucose | Episodes of hypoglycemia or hyperglycemia | during ICU stay (maximum 15 days) | 
| ICU Stay | Days of stay in ICU | From date of randomization until 100 months | 
| Mortality | Percentage of deaths in ICU | until the date of death from any cause until 100 months | 
| Change of type of EN administration | Change of EN administration modality | during ICU stay (maximum 15 days) | 
| Nutritional status:Glim Criteria | 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 | up to two days after admission to the ICU | 
| Nutritional status: Biochemical values | Measure with:biochemical values: albumin, prealbumin, total protein | up to two days after admission to the ICU | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric Emptying, Diarrea, Vomiting, Respiratory Aspiration of Gastric Content, Caloric Intake, Enteral nutrition, Critical care