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Clinical Trials/NCT05879263
NCT05879263
Recruiting
Not Applicable

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

Complejo Hospitalario Universitario de Albacete1 site in 1 country190 target enrollmentFebruary 10, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Enteral Nutrition
Sponsor
Complejo Hospitalario Universitario de Albacete
Enrollment
190
Locations
1
Primary Endpoint
Respiratory Complications
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 10, 2022
End Date
April 30, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Complejo Hospitalario Universitario de Albacete
Responsible Party
Principal Investigator
Principal Investigator

Maria Dolores Saiz Vinuesa

Principal Investigator

Complejo Hospitalario Universitario de Albacete

Eligibility Criteria

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

Outcomes

Primary Outcomes

Respiratory Complications

Time Frame: during ICU stay (maximum 15 days)

Respiratory aspiration of gastric content

Gastrointestinal Complications

Time Frame: during ICU stay (maximum 15 days)

Digestive intolerance: Diarrhea, vomiting, increased gastric residual volume(GRV)

Secondary Outcomes

  • ICU Stay(From date of randomization until 100 months)
  • Achievement of the caloric objective(during ICU stay (up to 15 days))
  • Nutritional status: Biochemical values(up to two days after admission to the ICU)
  • Nutritional status: MNA(up to two days after admission to the ICU)
  • Changes in blood glucose(during ICU stay (maximum 15 days))
  • Mortality(until the date of death from any cause until 100 months)
  • Change of type of EN administration(during ICU stay (maximum 15 days))
  • Nutritional status:Glim Criteria(up to two days after admission to the ICU)

Study Sites (1)

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