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Enteral NutritionENINCONCT05879263

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

A study testing INTERMITTENT ENTERAL NUTRITITION (IEN) and CONTINUOS ENTERAL NUTRITITION (CEN) in people with Enteral Nutrition and Critical Care, run by Complejo Hospitalario Universitario de Albacete at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Enteral Nutrition, Critical Care, Feeding Methods
What is being tested?
INTERMITTENT ENTERAL NUTRITITION (IEN) and CONTINUOS ENTERAL NUTRITITION (CEN)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
190 participants
Where
1 siteSpain
Study dates
10 Feb 2022to 30 Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Insulin dependent diabetic patients
  • Abdominal surgery
  • Dire prognosis

Trial locations and contacts

1 site in 1 country.

M.Dolores Saiz-Vinuesa, NURSE contact

0034967597100 ext. 21686

tebisama@hotmail.com

M.Pilar Córcoles-Jimenez, NURSE contact

0034967597169 ext. 37169

pcorcoles@sescam.org

Spain1 site, 1 recruiting

  • Maria Dolores Saiz Vinuesa

    Albacete, 02008

    MARIA DOLORES MD SAIZ VINUESA, NURSE, 629167321, tebisama@hotmail.com

    FRANCISCA F CALERO YÁNEZ, NURSE

    Recruiting

Other trials in Spain

About this study

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

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:

Read more
  • 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.

Being tested
INTERMITTENT ENTERAL NUTRITITION (IEN), CONTINUOS ENTERAL NUTRITITION (CEN)
Keywords
Gastric Emptying, Diarrea, Vomiting, Respiratory Aspiration of Gastric Content, Caloric Intake, Enteral nutrition, Critical care
Medical subject headings
Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INTERMITTENT ENTERAL NUTRITITION (IEN)Other

    Administration of Enteral Nutriton (EN) by nasogastric tube in 4 bolus (24h): Duration of the infusion 1hour each shot, using an infusion pump.

  • CONTINUOS ENTERAL NUTRITITION (CEN)Other

    Administration of Enteral Nutriton (EN) by nasogastric tube during 24 hours, using an infusion pump.

Study groups in NCT05879263
Study groupRoleWhat they receive
INTERMITTENT ENTERAL NUTRITITION (IEN)ExperimentalAdministration of Enteral Nutriton (EN) by nasogastric tube in 4 bolus (24h): Duration of the infusion 1hour each shot, using an infusion pump.
Receives: Other: INTERMITTENT ENTERAL NUTRITITION (IEN)
CONTINUOUS ENTERAL NUTRITION (CEN)Active comparatorAdministration of Enteral Nutriton (EN) by nasogastric tube during 24 hours, using an infusion pump.
Receives: Other: CONTINUOS ENTERAL NUTRITITION (CEN)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Respiratory Complications

    Respiratory aspiration of gastric content

    Measured: during ICU stay (maximum 15 days)

  2. Gastrointestinal Complications

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

    Measured: during ICU stay (maximum 15 days)

Secondary outcomes (8)

  1. Achievement of the caloric objective

    Time in hours to reach caloric goal

    Measured: during ICU stay (up to 15 days)

  2. 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

    Measured: up to two days after admission to the ICU

  3. Changes in blood glucose

    Episodes of hypoglycemia or hyperglycemia

    Measured: during ICU stay (maximum 15 days)

  4. ICU Stay

    Days of stay in ICU

    Measured: From date of randomization until 100 months

  5. Mortality

    Percentage of deaths in ICU

    Measured: until the date of death from any cause until 100 months

  6. Change of type of EN administration

    Change of EN administration modality

    Measured: during ICU stay (maximum 15 days)

  7. 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

    Measured: up to two days after admission to the ICU

  8. Nutritional status: Biochemical values

    Measure with:biochemical values: albumin, prealbumin, total protein

    Measured: up to two days after admission to the ICU

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2023
  2. Study start10 Feb 2022
  3. Primary completion29 Feb 2024 (estimated)
  4. Study completion30 Apr 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
190 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05879263
Sponsor's protocol ID
CHUA_59_07_2021
Acronym
ENINCO
Status last verified
May 2023
First submitted
3 May 2023
Last updated
30 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 19372071

  • 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.

    PubMed 29883514

  • 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.

    PubMed 30348463

  • 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.

    PubMed 29232262

  • 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.

    PubMed 24559000

  • 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.

    PubMed 12754584

  • 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.

    PubMed 29924423

  • 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.

    PubMed 34965317

  • 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.

    PubMed 36284334

Questions about this trial

What is this clinical trial studying?

A study testing INTERMITTENT ENTERAL NUTRITITION (IEN) and CONTINUOS ENTERAL NUTRITITION (CEN) in people with Enteral Nutrition and Critical Care, run by Complejo Hospitalario Universitario de Albacete at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact M.Dolores Saiz-Vinuesa, NURSE (0034967597100 ext. 21686, tebisama@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Respiratory Complications (time frame: during ICU stay (maximum 15 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05879263, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2023.

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