Clinical trial NCT05879263: "Efficacy of Intermittent Enteral Nutrition Versus Continuous Administration in Intensive Care"
Official title: "Efficacy of Intermittent Enteral Nutrition Versus Continuous Administration in Intensive Care Patients for the Reduction of Complications. Randomized Clinical Trial"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Enteral Nutrition
Critical Care
Feeding Methods
Gastric Feeding Tube
Keywords: Gastric Emptying
Diarrea
Vomiting
Respiratory Aspiration of Gastric Content
Caloric Intake
Enteral nutrition
Critical care
Lead sponsor: Complejo Hospitalario Universitario de Albacete
Sponsor class: OTHER
Collaborators: name: University of Castilla-La Mancha
First posted: 2023-05-30
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Respiratory Complications
timeFrame: during ICU stay (maximum 15 days)
measure: Gastrointestinal Complications
timeFrame: during ICU stay (maximum 15 days)
Secondary outcomes:
measure: Achievement of the caloric objective
timeFrame: during ICU stay (up to 15 days)
measure: Nutritional status: MNA
timeFrame: up to two days after admission to the ICU
measure: Changes in blood glucose
timeFrame: during ICU stay (maximum 15 days)
measure: ICU Stay
timeFrame: From date of randomization until 100 months
measure: Mortality
timeFrame: until the date of death from any cause until 100 months
measure: Change of type of EN administration
timeFrame: during ICU stay (maximum 15 days)
measure: Nutritional status:Glim Criteria
timeFrame: up to two days after admission to the ICU
measure: Nutritional status: Biochemical values
timeFrame: up to two days after admission to the ICU
Other outcomes:
Locations:
city: Albacete
country: Spain
facility: Maria Dolores Saiz Vinuesa
Study officials:
affiliation: Gerencia de Atención Integrada de Albacete
name: M.Dolores Saiz-Vinuesa, NURSE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen YC. Critical analysis of the factors associated with enteral feeding in preventing VAP: a systematic review. J Chin Med Assoc. 2009 Apr;72(4):171-8. doi: 10.1016/S1726-4901(09)70049-8.
citation: Lewis SR, Schofield-Robinson OJ, Alderson P, Smith AF. Enteral versus parenteral nutrition and enteral versus a combination of enteral and parenteral nutrition for adults in the intensive care unit. Cochrane Database Syst Rev. 2018 Jun 8;6(6):CD012276. doi: 10.1002/14651858.CD012276.pub2.
citation: Singer P, Blaser AR, Berger MM, Alhazzani W, Calder PC, Casaer MP, Hiesmayr M, Mayer K, Montejo JC, Pichard C, Preiser JC, van Zanten ARH, Oczkowski S, Szczeklik W, Bischoff SC. ESPEN guideline on clinical nutrition in the intensive care unit. Clin Nutr. 2019 Feb;38(1):48-79. doi: 10.1016/j.clnu.2018.08.037. Epub 2018 Sep 29.
citation: Patel JJ, Rosenthal MD, Heyland DK. Intermittent versus continuous feeding in critically ill adults. Curr Opin Clin Nutr Metab Care. 2018 Mar;21(2):116-120. doi: 10.1097/MCO.0000000000000447.
citation: Tavares de Araujo VM, Gomes PC, Caporossi C. Enteral nutrition in critical patients; should the administration be continuous or intermittent? Nutr Hosp. 2014 Mar 1;29(3):563-7. doi: 10.3305/nh.2014.29.3.7169.
citation: Serpa LF, Kimura M, Faintuch J, Ceconello I. Effects of continuous versus bolus infusion of enteral nutrition in critical patients. Rev Hosp Clin Fac Med Sao Paulo. 2003 Jan-Feb;58(1):9-14. doi: 10.1590/s0041-87812003000100003. Epub 2003 Apr 30.
citation: Ichimaru S. Methods of Enteral Nutrition Administration in Critically Ill Patients: Continuous, Cyclic, Intermittent, and Bolus Feeding. Nutr Clin Pract. 2018 Dec;33(6):790-795. doi: 10.1002/ncp.10105. Epub 2018 Jun 20.
citation: Thong D, Halim Z, Chia J, Chua F, Wong A. Systematic review and meta-analysis of the effectiveness of continuous vs intermittent enteral nutrition in critically ill adults. JPEN J Parenter Enteral Nutr. 2022 Aug;46(6):1243-1257. doi: 10.1002/jpen.2324. Epub 2022 Feb 13.
citation: Heffernan AJ, Talekar C, Henain M, Purcell L, Palmer M, White H. Comparison of continuous versus intermittent enteral feeding in critically ill patients: a systematic review and meta-analysis. Crit Care. 2022 Oct 25;26(1):325. doi: 10.1186/s13054-022-04140-8.