Undiluted and Diluted Nutrition

January 11, 2026 updated by: John Paul II Catholic University of Lublin

The Influence of Diluted and Undiluted Enteral Nutrition on Nutritional Tolerance in Critically Ill Patients After Gastrointestinal Surgery - a Randomized Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Approximately 50 % of the intensive care unit (ICU) population has feeding intolerance (FI), which includes nausea, vomiting, diarrhea, and others. Some studies suggest that FI can be alleviated in patients fed with supplemental parenteral nutrition (PN). Adult patients after elective major abdominal surgeries who are planned to be admitted to the ICU can be included in the trial. After the ICU admission, the patient will be stabilized, including warming, correction of water, electrolyte, and acid-base disorders, and blood transfusion if required. The fluid therapy will be monitored using the transpulmonary dilution technique. Then, an attending physician will contact an investigator. The investigator will decide about the randomization (no contraindication). The investigators plan to maintain fluid therapy with continuous Glucose-Na-K Baxter 50 mg/ml solution for infusion (GNAK). GNAK will be administered in the same flow as EN, enterally or intravenously (i.v.). Patients will be randomized to one of two studied groups: Continuous EN will be administered solely to the GI tract in the first group. The same dose of GNAK will be given i.v. (IVF group). In the second group, GNAK will be administered enterally with EN, a routine practice in our department (ENF group). The attending physician will correct all fluid disturbances with balanced fluids or blood products according to laboratory tests and hemodynamic monitoring. GNAK will only be given as maintenance fluid with EN.

The primary outcome of our study will be feeding intolerance (FI). FI is a composite outcome consisting of at least one of the following:

  • Incidents of vomiting
  • 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

Secondary outcomes (routinely performed procedures):

  • Incidents of nausea (nausea measured with a 4-point verbal descriptive scale (0=no nausea, 1=mild, 2=moderate, 3=severe)
  • Incidents of diarrhea (≥ three loose stools per day)
  • 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)
  • 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)
  • PN requirements (days of support, grams of proteins, extra protein calories per day, contribution of PN in total nutrition)
  • Insulin consumption (units per day and total per stay)
  • Electrolyte supplementation (potassium, phosphorus, calcium, and magnesium in mmol/ stay)
  • Enteral access obstruction (rinsing with fluid, need for replacement) per stay
  • Intraabdominal pressure (twice daily)
  • Sequential Organ Failure Assessment Score (daily)
  • Acute Physiology and Chronic Health Evaluation II (daily)
  • Fluid balance: additional fluids given intravenously during ICU stay
  • Blood products transfusion
  • Acute kidney injury, according to KDIGO definition
  • Usage of vasoactive drugs: cumulative dose per stay
  • Hemodynamic parameters, measured at least twice per day, such as stroke volume variation, pulse pressure variation, cardiac output, global end-diastolic volume, systemic vascular resistance, and extravascular lung water
  • Laboratory tests, including lactate, electrolytes, arterial blood gas analysis, coagulation, total blood count
  • Infections during the stay (site, antibiotics requirements)
  • Mechanical ventilation time (hours)
  • ICU stay (days)
  • Hospital stay (days)
  • Hospital mortality

Additional procedures:

  • Intestinal fatty-acid binding protein (I-FABP) collection from blood and urine once daily during ICU stay
  • Serum zonulin on the 1st day, 4th day, and at ICU discharge
  • Serum ketones collection at ICU admission, 4th day, and discharge
  • Gut microbiome collection at ICU admission and discharge (for 60 patients, 30 participants in each group)

Follow-up:

• Quality of recovery - phone interview 30 days after randomization

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Poland
      • Lublin, Poland, 20-718
        • Provincial Specialist Hospital in Lublin
        • Contact:
    • Województwo
      • Lublin, Województwo, Poland, 20-090
        • Center of Oncology of the Lublin Region
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Adults, ≥18, Scheduled for major abdominal surgery requiring ICU admission Having access to the GI tract (gastric or jejunal) Planned to be fed enterally

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental : Enteral nutrition fluid - ENF
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
GNAK will be administered to the gastrointestinal tract with EN in the same volume.
Experimental: Intravenous fluid - IVF
Enteral nutrition will be given continuously to the gastrointestinal tract. GNAK will be given continuously intravenously at the same volume.
Other: Intravenous fluid
Undiluted EN will be given to the gastrointestinal tract. GNAK, in the same volume, will be administered intravenously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients having vomiting.
Time Frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
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.
Time Frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraabdominal pressure
Time Frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Intraabdominal pressure via urinary catheter twice daily
From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Fluid balance
Time Frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Additional crystalloids or colloids given intravenously during ICU stay measured in milliliters
From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Blood products transfusion
Time Frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Transfusion of any blood products, including red-packed cells, fresh-frozen plasma, platelets, and cryoprecipitate, measured in units per stay.
From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Acute kidney injury (AKI)
Time Frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Recognition of AKI according to Kidney Disease: Improving Global Outcomes (KDIGO) definition
From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Vasoactive drugs
Time Frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Usage of vasoactive drugs including noradrenaline, dobutamine, dopamine, adrenaline, and others measured in milligrams as cumulative dose per stay
From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Stroke volume variation
Time Frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Measurement of stroke volume variation presented in percent twice daily during the patient stay
From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Lactates
Time Frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
At least once daily, arterial blood lactates (mmol/L) will be measured
From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Complete blood count (CBC)
Time Frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Once daily CBC will be tested
From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Blood proteins
Time Frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Plasma protein concentrations (g/dL) will measured at least once a week.
From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Infection site
Time Frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Site of infection during the ICU stay.
From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Antibiotics
Time Frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Antibiotics wchich will be used in ICU.
From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Blood albumins
Time Frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Plasma albumin concentrations (g/dL) will measured at least once a week.
From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
C-reactive protein (CRP)
Time Frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
CRP (mg/L) will be measured once daily.
From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Procalcitonin (PCT)
Time Frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
PCT (ng/mL) will be measured once daily.
From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Mechanical ventilation
Time Frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Mechanical ventilation time in hours per stay
From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Intensive care unit (ICU) stay
Time Frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
ICU stay in days
From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Hospital stay
Time Frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Hospital stay in days
From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Hospital mortality
Time Frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
In-hospital mortality
From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Zonulin
Time Frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Zonulin concetration (ng/mL) will measured in the patient's blood on the 1st day, 4th day, and at the ICU discharge.
From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Ketones
Time Frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Serum ketone concentrations (mmol/L) will be collected and measured at ICU admission, 4th day, and discharge
From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Microbiome
Time Frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Intestinal microbiome collection upon admission and discharge from the ICU. Sequencing of the V3 V4 region of the 16SrRNA gene using NGS using Illumina technology, 2x250 bp, min. 100,000 readings, including DNA isolation. Preparation of the OTU table and basic alpha biodiversity measures
From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Quality of recovery
Time Frame: 30 days after randomization
Phone interview using a modified version of Quality of recovery-40 scale (37-185 points,more points better) 30 days after randomization
30 days after randomization
Number of participants having nausea
Time Frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
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
Time Frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
≥ 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
Time Frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
> 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 be achieved
Time Frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
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
Days of support with PN
Time Frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
PN requirements (days of support, grams of proteins, extra protein calories per day, 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
Time Frame: 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 (units per day and total per stay)
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
Time Frame: 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 (potassium, phosphorus, calcium, and magnesium in mmol/ stay)
From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Sequential Organ Failure Assessment Score
Time Frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Calculating SOFA daily - from 0 to 24 - 0 means the lack of organ failure; 24 multiorgan failure
From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
APACHE II
Time Frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
APACHE II (Acute Physiology and Chronic Health Evaluation II) measured daily. Ranging from 0 to 71. 0 - meaning no organ failure. 71 - meaning multiorgan failure.
From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Cardiac output
Time Frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Measurement of cardiac output (L/min) twice daily during the patient's stay
From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Systemic vascular resistance
Time Frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Measurement of systemic vascular resistance (dynes/sec/cm-5) twice daily during the patient's stay
From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
. Intestinal fatty-acid binding protein (I-FABP)
Time Frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
I-FABP concentrations (nmol/mL) will be measured in the blood and urine once daily.
From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

John Paul II Catholic University of Lublin

Collaborators

Center of Oncology of the Lublin Region
Provincial Specialist Hospital in Lublin

Investigators

  • Principal Investigator: Michał Borys, Medical Faculty, John Paul II Catholic University of Lublin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 2, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

January 11, 2026

First Submitted That Met QC Criteria

January 11, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 11, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUL nr 21/2025
  • RG 1/2024 (Other Grant/Funding Number: NUTRICIA FOUNDATION)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Critical Illness

Clinical Trials on Enteral fluid

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mozambique

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe