Undiluted and Diluted Nutrition

NCT07352150 | Not Yet Recruiting

• 2 other identifiers: KUL nr 21/2025RG 1/2024
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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 to assess feeding intolerance in both patient groups.

Conditions

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

Keywords

Zonulin; Intestinal fatty-acid binding protein (I-FABP); Ketones; enteral feeding; GNAK

Outcome Measures

Primary Outcomes (2)

• Number of patients having vomiting.

  Any incidents of vomiting.

  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 who received prokinetic agents.

  Administration of prokinetic agents starting with both erythromycin (125mg twice daily enterally) and metoclopramide (10mg three times per day i.v.) due to significant EN intolerance, i.e. ≥ 2 incidents of vomiting/24h; \> 500 mL of gastric volume/6h; presence of gastric contents/nutrition in the endotracheal tube due to regurgitation

  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 (34)

• Number of participants having nausea

  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

  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

  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 be achieved

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

• 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

Study Arms (2)

Experimental : Enteral nutrition fluid - ENF

EXPERIMENTAL

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

Other: Intravenous fluid

Interventions

Enteral fluid OTHER

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

Experimental : 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.

Intravenous fluid - IVF

Eligibility Criteria

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

You may qualify if:

• Adults, ≥18, 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

• John Paul II Catholic University of Lublin: lead
• Center of Oncology of the Lublin Region: collaborator
• Provincial Specialist Hospital in Lublin: collaborator

Study Sites (2)

Center of Oncology of the Lublin Region

Lublin, Województwo, 20-090, Poland

Location

Provincial Specialist Hospital in Lublin

Lublin, 20-718, 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

• Michał Borys

  Medical Faculty, John Paul II Catholic University of Lublin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michal Borys

CONTACT

+48506350569; michal.borys@kul.pl

Katarzyna Kosz

CONTACT

+48 508612175; Michalborys1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: January 11, 2026
• First Posted: January 20, 2026
• Study Start: February 2, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2)