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NCT Number: NCT06516835

Diluted and Undiluted Enteral Nutrition

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.

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Key information

Conditions

Critical Illness Acid-Base Imbalance Acidosis Digestive System Diseases Disease Attributes Enteral Feeding Intolerance Gastro-Intestinal Disorder Ketosis Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Quality of Life Surgery

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Provincial Hospital in Gorzow Wielkopolski, Gorzów Wielkopolski, Poland

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About this study

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 nausea and vomiting (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)
  • Administration of prokinetic agents. Starting with both erythromycin (125mg twice daily enterally) and metoclopramide (10mg three times per day i.v.)

Secondary outcomes (routinely performed procedures):

  • 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 (twice daily)
  • Fluid balance: additional fluids given intravenously during ICU stay
  • Blood product 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
  • 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

Follow-up:

  • Quality of recovery - phone interview 30 days after randomization

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Treatment and study plan

Enteral fluid

Other

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

Other names: ENF

Intravenous fluid

Other

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

Other names: IVF

Primary outcomes

  1. Number of participants having nausea and 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

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

  2. 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

    Incidents of diarrhea (≥ three loose stools per day)

  3. 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

    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)

  4. Number of participants in whom target EN will not 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)

  5. Number of participants in whom prokinetic agents will be used

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

Secondary outcomes

  1. 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

    Days of support with parenteral nutrition during the ICU stay.

  2. Contribution of PN in total nutrition

    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

    Percentage contribution of parenteral nutrition in total patient feeding understand as protein demands

  3. 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

  4. 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

  5. Enteral access obstruction

    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

    Need for replacement outside the ICU or under endoscopy assistance. Number of such procedures per stay.

  6. 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

  7. Sequential Organ Failure Assessment Score (SOFA)

    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 twice daily - from 0 to 24 - 0 means the lack of organ failure; 24 multiorgan failure

  8. 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

  9. 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.

  10. 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

  11. 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

  12. 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

  13. 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) with pulmonary thermodilution technique twice daily during the patient's stay

  14. 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) with pulmonary thermodilution technique twice daily during the patient's stay

  15. Extravascular lung water

    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 extravascular lung water index (ml/kg) with pulmonary thermodilution technique twice daily during the patient's stay

  16. 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

  17. 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

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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.

  29. 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.

  30. 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

  31. 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

  32. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Michal Borys, MD, PhD

CONTACT

[email protected]

+48 506350569

Pawel Piwowarczyk, MD, PhD

CONTACT

[email protected]

+48 511285352

Sponsors and collaborators

Lead sponsor

Medical University of Lublin

Other

Collaborators

  • Catholic University of Lublin
  • Nutricia Fundation

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 24, 2024
Registry last updated
Jul 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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