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| ID | Type | Description | Link |
|---|---|---|---|
| RG 1/2024 | Other Grant/Funding Number | NUTRICIA FOUNDATION |
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| Name | Class |
|---|---|
| Center of Oncology of the Lublin Region | UNKNOWN |
| Provincial Specialist Hospital in Lublin | UNKNOWN |
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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.
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:
Secondary outcomes (routinely performed procedures):
Additional procedures:
Follow-up:
• Quality of recovery - phone interview 30 days after randomization
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Intravenous fluid - IVF | Experimental | Enteral nutrition will be given continuously to the gastrointestinal tract. GNAK will be given continuously intravenously at the same volume. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enteral fluid | Other | GNAK will be administered to the gastrointestinal tract with EN in the same volume. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of patients having vomiting. | Any incidents of vomiting. | From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first |
| Number of participants who received prokinetic agents. | Administration of prokinetic agents starting with both erythromycin (125mg twice daily enterally) and metoclopramide (10mg three times per day i.v.) due to significant EN intolerance, i.e. ≥ 2 incidents of vomiting/24h; > 500 mL of gastric volume/6h; presence of gastric contents/nutrition in the endotracheal tube due to regurgitation | From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants having nausea | 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 |
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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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michal Borys | Contact | +48506350569 | michal.borys@kul.pl | |
| Katarzyna Kosz | Contact | +48 508612175 | Michalborys1@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Michał Borys | Medical Faculty, John Paul II Catholic University of Lublin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center of Oncology of the Lublin Region | Lublin | Województwo | 20-090 | Poland |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D004066 | Digestive System Diseases |
| D007662 | Ketosis |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000138 | Acidosis |
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Two groups will be randomly allocated to ENF or IVF group
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| Intravenous fluid | Other | Undiluted EN will be given to the gastrointestinal tract. GNAK, in the same volume, will be administered intravenously. |
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≥ 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 | > 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 | 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 | 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 | 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 | 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 |
| Intraabdominal pressure | 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 |
| Sequential Organ Failure Assessment Score | 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 | 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 |
| Fluid balance | 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 | 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) | 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 | 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 | 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 |
| Cardiac output | 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 | 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 |
| Lactates | 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) | 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 | 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 | 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 | 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 | 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) | 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) | 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 | 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 | 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 | 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 | 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 |
| . Intestinal fatty-acid binding protein (I-FABP) | 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 |
| Zonulin | 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 | 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 | 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 | 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 |
| Provincial Specialist Hospital in Lublin | Lublin | 20-718 | Poland |
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| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |