Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06516835
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-07
Brief Title:
Diluted and Undiluted Enteral Nutrition
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Influence of Diluted and Undiluted Enteral Nutrition on Nutritional Tolerance in Critically Ill Patients After Gastrointestinal Surgery - a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 mgml solution for infusion GNAK GNAK will be administered in the same flow as EN enterally or intravenously iv
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 iv 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 0no nausea 1mild 2moderate 3severe
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 13kg 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 iv
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
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 mgml solution for infusion GNAK GNAK will be administered in the same flow as EN enterally or intravenously iv
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 iv 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 0no nausea 1mild 2moderate 3severe
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 13kg 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 iv
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None