Critical IllnessNCT06516835
Diluted and Undiluted Enteral Nutrition
A study testing Enteral fluid and Intravenous fluid in people with Critical Illness and Surgery, run by Medical University of Lublin at 5 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 to 80 years
- Conditions the study is for
- Critical Illness, 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
- 60 participants
- Where
- 5 sitesPoland
- Study dates
- 2 Jan 2025to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Poland5 sites
Provincial Hospital in Gorzow Wielkopolski
Gorzów Wielkopolski, 66-400
Miroslaw Czuczwar, MD, PhD
Fifth Military Hospital
Krakow, 30-901
Wojciech Szczeklik, MD, PhD
First Military Hospital
Lublin, 20-049
Elzbieta Rypulak, MD, PhD, +48791127036, elzbieta.rypulak@gmail.com
II Department of Anesthesia and Intensive Care, Medical University of Lublin
Lublin, 20-081
Provincial Hospital in Opole
Opole, 45-372
Tomasz Czarnik, MD, PhD
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 feeding intolerance assessment in both groups of patients.
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 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
- Conditions
- Critical Illness, Surgery, Enteral Feeding Intolerance, Gastro-Intestinal Disorder, Quality of Life
- Being tested
- Enteral fluid, Intravenous fluid
- Keywords
- Zonulin, Intestinal fatty-acid binding protein (I-FABP), Ketones, Microbiome
- 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
Also called ENF
GNAK will be administered to the gastrointestinal tract with EN in the same volume.
Intravenous fluidOther
Also called IVF
Undiluted EN will be given to the gastrointestinal tract. GNAK, in the same volume, will be administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Intravenous fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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))
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
Incidents of 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
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 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)
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 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.)
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 (32)
Days of support with PN
Days of support with parenteral nutrition 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
Contribution of PN in total nutrition
Percentage contribution of parenteral nutrition in total patient feeding understand as protein demands
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
Enteral access obstruction
Need for replacement outside the ICU or under endoscopy assistance. Number of such procedures 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
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 (SOFA)
Calculating SOFA twice 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
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) with pulmonary thermodilution technique 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) with pulmonary thermodilution technique 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
Extravascular lung water
Measurement of extravascular lung water index (ml/kg) with pulmonary thermodilution technique 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 posted24 Jul 2024
- Study start2 Jan 2025 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion30 Apr 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Lublin
- Sponsor type
- University, hospital or other
- Collaborators
- Nutricia Fundation, Catholic University of Lublin
- Responsible party
- Principal investigator, Michał Borys, Medical University of Lublin
- Investigators
- Michal Borys, MD, PhD, Principal investigator, Medical University of Lublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06516835
- Sponsor's protocol ID
- KE-0254/92/05/2024
- Status last verified
- Jul 2024
- First submitted
- 7 Jul 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Diluted and Undiluted Enteral Nutrition on Nutritional Tolerance in Critically Ill Patients After Gastrointestinal Surgery - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06516835
- Acronym / sponsor ID
- KE-0254/92/05/2024
- Conditions
- Critical Illness, Surgery, Enteral Feeding Intolerance, Gastro-Intestinal Disorder, Quality of Life
- Keywords
- Zonulin, Intestinal fatty-acid binding protein (I-FABP), Ketones, Microbiome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medical University of LublinUniversity, hospital or other
- Collaborators
- Nutricia Fundation, Catholic University of Lublin
- Study start
- 2 Jan 2025 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two groups will be randomly allocated to ENF or IVF group
| Arm | Type | Receives |
|---|---|---|
| Enteral nutrition fluid - ENF | Experimental | Other: Enteral fluidEnteral 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. |
| Intravenous fluid - IVF | Experimental | Other: Intravenous fluidEnteral nutrition will be given continuously to the gastrointestinal tract. GNAK will be given continuously intravenously in the same volume. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Scheduled for major abdominal surgery requiring ICU admission
- Having access to the GI tract (gastric or jejunal)
- Planned to be fed enterally
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enteral fluidAlso: ENFGNAK will be administered to the gastrointestinal tract with EN in the same volume. | Other | Enteral nutrition fluid - ENF |
| Intravenous fluidAlso: IVFUndiluted EN will be given to the gastrointestinal tract. GNAK, in the same volume, will be administered intravenously. | Other | Intravenous fluid - IVF |
Primary outcome
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))
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)
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)
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)
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.)
32 secondary outcomes
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 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
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
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
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
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
Quality of recovery
Time frame: 30 days after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michal Borys, MD, PhD principal investigator
Medical University of Lublin
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enteral fluid and Intravenous fluid in people with Critical Illness and Surgery, run by Medical University of Lublin at 5 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michal Borys, MD, PhD (+48 506350569, michalborys1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024.