Critical IllnessNCT07352150
Undiluted and Diluted Nutrition
A study testing Enteral fluid and Intravenous fluid in people with Critical Illness and Gastro Intestinal Surgery, run by John Paul II Catholic University of Lublin at 2 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Gastro Intestinal Surgery, Enteral Feeding Intolerance
- What is being tested?
- Enteral fluid and Intravenous fluid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesPoland
- Study dates
- 2 Feb 2026to 30 Sep 2027
- Phase
- Interventional
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
- Adults, ≥18, Scheduled for major abdominal surgery requiring ICU admission Having access to the GI tract (gastric or jejunal) Planned to be fed enterally
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Poland2 sites
Center of Oncology of the Lublin Region
Lublin, Województwo, 20-090
Michał Borys, 506350569, mborys@cozl.pl
Katarzyna Kosz, +48 508612 175, katarzyna.kosz@kul.pl
Provincial Specialist Hospital in Lublin
Lublin, 20-718
Paweł Piwowarczyk, +48 511285352, pawel.piwowarczyk@kul.pl
About this study
Official title: 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.
Read the 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
- Conditions
- Critical Illness, Gastro Intestinal Surgery, Enteral Feeding Intolerance, Gastro-Intestinal Disorder, Quality of Lifte
- Being tested
- Enteral fluid, Intravenous fluid
- Keywords
- Zonulin, Intestinal fatty-acid binding protein (I-FABP), Ketones, enteral feeding, GNAK
- Medical subject headings
- Critical Illness, Digestive System Diseases, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteral fluidOther
GNAK will be administered to the gastrointestinal tract with EN in the same volume.
Intravenous fluidOther
Undiluted EN will be given to the gastrointestinal tract. GNAK, in the same volume, will be administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Intravenous fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients having vomiting.
Any incidents of vomiting.
Measured: 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
Measured: 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
nausea measured with a 4-point verbal descriptive scale (0=no nausea, 1=mild, 2=moderate, 3=severe)
Measured: 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
≥ three loose stools per day
Measured: 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
> 500 ml of gastric aspirate/ 6 hours. Only in patients after lower GI tract surgeries (with intact stomach and gastric feeding)
Measured: 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
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)
Measured: 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
PN requirements (days of support, grams of proteins, extra protein calories per day, contribution of PN in total nutrition)
Measured: 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
Insulin consumption (units per day and total per stay)
Measured: 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
Electrolyte supplementation (potassium, phosphorus, calcium, and magnesium in mmol/ stay)
Measured: 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
Intraabdominal pressure via urinary catheter twice daily
Measured: 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
Calculating SOFA daily - from 0 to 24 - 0 means the lack of organ failure; 24 multiorgan failure
Measured: 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
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.
Measured: 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
Additional crystalloids or colloids given intravenously during ICU stay measured in milliliters
Measured: 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
Transfusion of any blood products, including red-packed cells, fresh-frozen plasma, platelets, and cryoprecipitate, measured in units per stay.
Measured: 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)
Recognition of AKI according to Kidney Disease: Improving Global Outcomes (KDIGO) definition
Measured: 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
Usage of vasoactive drugs including noradrenaline, dobutamine, dopamine, adrenaline, and others measured in milligrams as cumulative dose per stay
Measured: 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
Measurement of stroke volume variation presented in percent twice daily during the patient stay
Measured: 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
Measurement of cardiac output (L/min) twice daily during the patient's stay
Measured: 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
Measurement of systemic vascular resistance (dynes/sec/cm-5) twice daily during the patient's stay
Measured: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Lactates
At least once daily, arterial blood lactates (mmol/L) will be measured
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)
Once daily CBC will be tested
Measured: 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
Plasma protein concentrations (g/dL) will measured at least once a week.
Measured: 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
Site of infection during the ICU stay.
Measured: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Antibiotics
Antibiotics wchich will be used in ICU.
Measured: 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
Plasma albumin concentrations (g/dL) will measured at least once a week.
Measured: 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)
CRP (mg/L) will be measured once daily.
Measured: 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)
PCT (ng/mL) will be measured once daily.
Measured: 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
Mechanical ventilation time in hours per stay
Measured: 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
ICU stay in days
Measured: 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
Hospital stay in days
Measured: 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
In-hospital mortality
Measured: 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)
I-FABP concentrations (nmol/mL) will be measured in the blood and urine once daily.
Measured: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Zonulin
Zonulin concetration (ng/mL) will measured in the patient's blood on the 1st day, 4th day, and at the ICU discharge.
Measured: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Ketones
Serum ketone concentrations (mmol/L) will be collected and measured at ICU admission, 4th day, and discharge
Measured: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Microbiome
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
Measured: 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
Phone interview using a modified version of Quality of recovery-40 scale (37-185 points,more points better) 30 days after randomization
Measured: 30 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start2 Feb 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups will be randomly allocated to ENF or IVF group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- John Paul II Catholic University of Lublin
- Sponsor type
- University, hospital or other
- Collaborators
- Center of Oncology of the Lublin Region, Provincial Specialist Hospital in Lublin
- Responsible party
- Sponsor
- Investigators
- Michał Borys, Principal investigator, Medical Faculty, John Paul II Catholic University of Lublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07352150
- Sponsor's protocol ID
- KUL nr 21/2025
- Other IDs
- RG 1/2024
- Status last verified
- Jan 2026
- First submitted
- 11 Jan 2026
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No