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

NCT ID: NCT05879263

Last Updated: 2023-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-10

Study Completion Date

2024-04-30

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.

Detailed Description

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Conditions

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Enteral Nutrition Critical Care Feeding Methods Gastric Feeding Tube

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

By the nature of the intervention(intermittent or continuous administration of enteral nutrition) is impossible to mask it to participats, care provider or investigators.

Study Groups

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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.

Group Type EXPERIMENTAL

INTERMITTENT ENTERAL NUTRITITION (IEN)

Intervention Type OTHER

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

CONTINUOUS ENTERAL NUTRITION (CEN)

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

Group Type ACTIVE_COMPARATOR

CONTINUOS ENTERAL NUTRITITION (CEN)

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

CONTINUOS ENTERAL NUTRITITION (CEN)

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

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Castilla-La Mancha

OTHER

Sponsor Role collaborator

Complejo Hospitalario Universitario de Albacete

OTHER

Sponsor Role lead

Responsible Party

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Maria Dolores Saiz Vinuesa

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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M.Dolores Saiz-Vinuesa, NURSE

Role: PRINCIPAL_INVESTIGATOR

Gerencia de Atención Integrada de Albacete

Locations

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Maria Dolores Saiz Vinuesa

Albacete, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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M.Dolores Saiz-Vinuesa, NURSE

Role: CONTACT

0034967597100 ext. 21686

M.Pilar Córcoles-Jimenez, NURSE

Role: CONTACT

0034967597169 ext. 37169

Facility Contacts

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MARIA DOLORES MD SAIZ VINUESA, NURSE

Role: primary

629167321

References

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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.

Reference Type BACKGROUND
PMID: 19372071 (View on PubMed)

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.

Reference Type RESULT
PMID: 29883514 (View on PubMed)

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.

Reference Type RESULT
PMID: 30348463 (View on PubMed)

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.

Reference Type RESULT
PMID: 29232262 (View on PubMed)

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.

Reference Type RESULT
PMID: 24559000 (View on PubMed)

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.

Reference Type RESULT
PMID: 12754584 (View on PubMed)

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.

Reference Type RESULT
PMID: 29924423 (View on PubMed)

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.

Reference Type RESULT
PMID: 34965317 (View on PubMed)

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.

Reference Type RESULT
PMID: 36284334 (View on PubMed)

Related Links

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http://www.joannabriggslibrary.org/jbilibrary/index.php/jbisrir/article/view/1129

Effectiveness of continuous enteral nutrition versus intermittent enteral nutrition in intensive care patients: a systematic review.

Other Identifiers

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CHUA_59_07_2021

Identifier Type: -

Identifier Source: org_study_id

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