Diluted and Undiluted Enteral Nutrition

NCT06516835 | Not Yet Recruiting

• 1 other identifier: KE-0254/92/05/2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

Brief Summary

Adult patients after elective major abdominal surgeries who are planned to be admitted to the Intensive Care Unit (ICU) can be included in the trial. Each patient will be fed via the gastrointestinal tract. Half of the patients will receive enteral nutrition (EN) with additional fluids, and the rest will receive undiluted EN. The primary aim of this study is feeding intolerance assessment in both groups of patients.

Conditions

Critical Illness; Surgery; Enteral Feeding Intolerance; Gastro-Intestinal Disorder; Quality of Life

Keywords

Zonulin; Intestinal fatty-acid binding protein (I-FABP); Ketones; Microbiome

Outcome Measures

Primary Outcomes (5)

• Number of participants having nausea and vomiting

  Incidents of nausea and vomiting (nausea measured with a 4-point verbal descriptive scale (0=no nausea, 1=mild, 2=moderate, 3=severe))

  From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first

• Number of participants having diarrhea

  Incidents of diarrhea (≥ three loose stools per day)

  From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first

• Number of participants having increased gastric residual volume

  Increased gastric residual volume (\> 500 ml of gastric aspirate/ 6 hours). Only in patients after lower GI tract surgeries (with intact stomach and gastric feeding)

  From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first

• Number of participants in whom target EN will not be achieved

  Achieving target EN on day three and later: 80% of protein requirements according to ESPEN (1.3/kg of ideal body weight (patients BMI \< 30) or adjusted body weight, BMI ≥ 30)

  From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first

• Number of participants in whom prokinetic agents will be used

  Administration of prokinetic agents according to the intensivist discretion. Starting with both erythromycin (125 mg twice daily enterally) and metoclopramide (10mg three times per day i.v.)

  From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first

Secondary Outcomes (32)

• Days of support with PN

  From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first

• Contribution of PN in total nutrition

  From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first

• Insulin consumption

  From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first

• Electrolyte supplementation

  From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first

• Enteral access obstruction

  From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first

Study Arms (2)

Enteral nutrition fluid - ENF

EXPERIMENTAL

Enteral nutrition will be given continuously with glucose-Na-K Baxter 50 mg/ml solution for infusion (GNAK)-both products to the gastrointestinal tract in the same volume.

Other: Enteral fluid

Intravenous fluid - IVF

EXPERIMENTAL

Enteral nutrition will be given continuously to the gastrointestinal tract. GNAK will be given continuously intravenously in the same volume.

Other: Intravenous fluid

Interventions

Enteral fluid OTHER

GNAK will be administered to the gastrointestinal tract with EN in the same volume.

Also known as: ENF

Enteral nutrition fluid - ENF

Intravenous fluid OTHER

Undiluted EN will be given to the gastrointestinal tract. GNAK, in the same volume, will be administered intravenously.

Also known as: IVF

Intravenous fluid - IVF

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled for major abdominal surgery requiring ICU admission
• Having access to the GI tract (gastric or jejunal)
• Planned to be fed enterally

You may not qualify if:

• Patients unable to give informed consent
• After emergency surgeries
• Without access to the GI tract
• Individuals with contraindications to EN, such as short bowel syndrome, uncompensated shock, acidosis (pH \< 7.1; lactate \> 5 mmol/l), bleeding from the upper GI tract, obstruction, intestinal ischemia, abdominal compartment syndrome
• Patients with symptomatic gastro-esophageal reflux
• Expected ICU stay \< 3 days
• Pregnancy and lactation

Sponsors & Collaborators

• Medical University of Lublin: lead
• Nutricia Fundation: collaborator
• Catholic University of Lublin: collaborator

Study Sites (5)

Provincial Hospital in Gorzow Wielkopolski

Gorzów Wielkopolski, 66-400, Poland

Location

Fifth Military Hospital

Krakow, 30-901, Poland

Location

First Military Hospital

Lublin, 20-049, Poland

Location

II Department of Anesthesia and Intensive Care, Medical University of Lublin

Lublin, 20-081, Poland

Location

Provincial Hospital in Opole

Opole, 45-372, Poland

Location

MeSH Terms

Conditions

Critical Illness; Digestive System Diseases; Ketosis

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Michal Borys, MD, PhD

  Medical University of Lublin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michal Borys, MD, PhD

CONTACT

+48 506350569; michalborys1@gmail.com

Pawel Piwowarczyk, MD, PhD

CONTACT

+48 511285352; piwowarczyk.pawel@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patient will not be aware of the allocation
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Model Details: Two groups will be randomly allocated to ENF or IVF group

Study Record Dates

• First Submitted: July 7, 2024
• First Posted: July 24, 2024
• Study Start: January 2, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

PL (5)