Ignite Creation Date:
2024-05-06 @ 3:53 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04791774
Status:
COMPLETED
Last Update Posted:
2021-03-10
First Post:
2017-05-02
Brief Title:
Protein-bound Versus Free Amino Acid Nutrition During INtestinal Malabsorption in Critical Illness
Sponsor:
Maastricht University Medical Center
Organization:
Maastricht University Medical Center
Study Overview
Official Title:
Systemic Bioavailability of Enteral Protein-bound Versus Free Amino Acid Nutrition During Intestinal Malabsorption in Critical Illness
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PANINI
Brief Summary:
In the current study we willquantitate the difference in digestion and absorption kinetics of dietary whole protein versus free amino acids in vivo in critically ill patients admitted to the intensive care unit suffering from malabsorption 16 adult mechanically ventilated ICU patients with clinical signs of malabsorption faecal weight 350 gday will be included All patients will receive a primed continuous intravenous infusion of L-ring2H5-phenylalanine and L-35-2H2-Tyrosine for the duration of the study period After reaching an isotopic steady state 15 hours patients will receive either 1-13C- phenylalanine labelled milk protein or free amino acids with an identical constitution and 1-13C-phenylalanine
Main study endpoint will be the splanchnic extraction of phenylalanine calculated from systemic 1-13C- and L-ring2H5-phenylalanine enrichment
Main study endpoint will be the splanchnic extraction of phenylalanine calculated from systemic 1-13C- and L-ring2H5-phenylalanine enrichment
Detailed Description:
Background of the study
The importance of the provision of sufficient protein in critical illness is increasingly recognized Protein malabsorption seems to be an underestimated but substantial problem in critically ill patients limiting the amount of this important nutrient that actually becomes available within the systemic circulation Among several contributors to malabsorption in critical illness exocrine pancreatic insufficiency has recently emerged as a regularly occurring phenomenon during critical illness Pancreatic insufficiency could lead to reduced digestion and subsequent uptake of enteral provided proteins A proposed solution to this problem could be the use of elementary feeds containing free amino acids instead of whole protein Due to the lack of easy applicable and reproducible tests for protein malabsorption the true efficacy of these feeds is still unknown We hypothesize that enteral nutrition containing free amino acids leads to higher systemic levels of amino acids and will therefore increase the amount of dietary amino acids available for protein synthesis
Objective of the study
To quantitate the difference in digestion and absorption kinetics of dietary whole protein versus free amino acids in vivo in patients admitted to the ICU suffering from malabsorption
Study design
Randomized single-blind controlled single-centre intervention study
Study population
16 adult mechanically ventilated ICU patients with clinical signs of malabsorption faecal weight 350 gday
Intervention
Normal enteral nutrition will be ceased 8 hours before the start of study participation All patients will receive a primed continuous intravenous infusion of L-ring2H5-phenylalanine and L-35-2H2-Tyrosine for the duration of the study period After reaching an isotopic steady state 15 hours patients will receive either 1-13C- phenylalanine labelled milk protein or free amino acids with an identical constitution and 1-13C-phenylalanine
Primary study parametersoutcome of the study
Main study endpoint will be the splanchnic extraction of phenylalanine calculated from systemic 1-13C- and L-ring2H5-phenylalanine enrichment
Secundary study parametersoutcome of the study
Secondary endpoints include the impact of enteral nutrition on whole body protein balance glucose and insulin concentrations and faecal energy and protein loss as a measure of malabsorption
Nature and extent of the burden and risks associated with participation benefit and group relatedness
Total study participation will take 16 hours including 8 hours of fasting Arterial blood samples will be collected regularly with 50 ml of blood being sampled in total amounting to a maximum of 10 of total circulating volume All infusions as well as blood sample collection will be performed through indwelling catheters necessary for normal ICU treatment meaning no lines or nasogastric tubes will have to be placed for the purposes of the study Both isotopically labelled protein and free amino acids have been proven safe for use in humans and carry no harmful risks for the study participant Changes in protein digestion absorption and metabolism are specific to critical illness and their impact on the clinical condition and recovery of patients is severe Investigating new strategies to modulate these effects are therefore essential but require experimental studies in a vulnerable population The risks in the present study are minimal whereas the results could help improve nutritional management in the intensive care
The importance of the provision of sufficient protein in critical illness is increasingly recognized Protein malabsorption seems to be an underestimated but substantial problem in critically ill patients limiting the amount of this important nutrient that actually becomes available within the systemic circulation Among several contributors to malabsorption in critical illness exocrine pancreatic insufficiency has recently emerged as a regularly occurring phenomenon during critical illness Pancreatic insufficiency could lead to reduced digestion and subsequent uptake of enteral provided proteins A proposed solution to this problem could be the use of elementary feeds containing free amino acids instead of whole protein Due to the lack of easy applicable and reproducible tests for protein malabsorption the true efficacy of these feeds is still unknown We hypothesize that enteral nutrition containing free amino acids leads to higher systemic levels of amino acids and will therefore increase the amount of dietary amino acids available for protein synthesis
Objective of the study
To quantitate the difference in digestion and absorption kinetics of dietary whole protein versus free amino acids in vivo in patients admitted to the ICU suffering from malabsorption
Study design
Randomized single-blind controlled single-centre intervention study
Study population
16 adult mechanically ventilated ICU patients with clinical signs of malabsorption faecal weight 350 gday
Intervention
Normal enteral nutrition will be ceased 8 hours before the start of study participation All patients will receive a primed continuous intravenous infusion of L-ring2H5-phenylalanine and L-35-2H2-Tyrosine for the duration of the study period After reaching an isotopic steady state 15 hours patients will receive either 1-13C- phenylalanine labelled milk protein or free amino acids with an identical constitution and 1-13C-phenylalanine
Primary study parametersoutcome of the study
Main study endpoint will be the splanchnic extraction of phenylalanine calculated from systemic 1-13C- and L-ring2H5-phenylalanine enrichment
Secundary study parametersoutcome of the study
Secondary endpoints include the impact of enteral nutrition on whole body protein balance glucose and insulin concentrations and faecal energy and protein loss as a measure of malabsorption
Nature and extent of the burden and risks associated with participation benefit and group relatedness
Total study participation will take 16 hours including 8 hours of fasting Arterial blood samples will be collected regularly with 50 ml of blood being sampled in total amounting to a maximum of 10 of total circulating volume All infusions as well as blood sample collection will be performed through indwelling catheters necessary for normal ICU treatment meaning no lines or nasogastric tubes will have to be placed for the purposes of the study Both isotopically labelled protein and free amino acids have been proven safe for use in humans and carry no harmful risks for the study participant Changes in protein digestion absorption and metabolism are specific to critical illness and their impact on the clinical condition and recovery of patients is severe Investigating new strategies to modulate these effects are therefore essential but require experimental studies in a vulnerable population The risks in the present study are minimal whereas the results could help improve nutritional management in the intensive care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None