Endogenous Energy Production in Critically Ill Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKarolinska University Hospital
About this trial
The aim of this study is to investigate when critically ill patients transition from a non-suppressible catabolism to a normal response to feeding.
Endogenous production of glucose, fat and protein will be studied on a minimum of two occasions in mechanically ventilated ICU patients, in a fasted state and during parenteral nutrition. Substrate kinetics are estimated by a tracer dilution method using infusions of isotopically labeled glucose, glycerol and phenylalanine. Blood sampling for metabolomics analysis will be performed to elucidate potential biomarkers indicating an anabolic response to nutrition.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
≥18 years old and admitted to the ICU
Invasive mechanical ventilation
Arterial and central line in situ
Expected to remain in ICU >72 hours
Disqualifiers
Lack of informed consent by patient/next of kin
Liver transplant
Acute or acute on chronic liver failure
Cirrhosis
Trial design
Design model
Parallel
Treatments tested in this trial
Stable isotope tracers
Other interventionDeuterium-labelled non-radioactive stable isotopes of glucose, phenylalanine and glycerol.
Parenteral nutrition
Dietary supplementParenteral nutrition infused a rate corresponding to 100% of measured energy expenditure, started after blood sampling during a baseline fasting period.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: ICU PatientsExperimental treatment 2 interventions
Group B: Control groupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Attenuation of glucose production in response to nutrition in early acute phase in ICU.
Difference in endogenous rate of appearance of glucose, calculated from enrichment of labelled substrates in plasma of glucose between the fasted and fed state in the early acute phase in ICU.
Time frame
Early acute phase of critical illness, i.e., 24-72 hours after ICU admission. The difference between substrate kinetics at 165-180 min and 345-360 min after the start of the tracer infusion will be calculated.2
Attenuation of phenylalanine production in response to nutrition in early acute phase in ICU.
Difference in endogenous rate of appearance of phenylalanine, calculated from enrichment of labelled substrates in plasma of phenylalanine, between the fasted and fed states in the early acute phase in ICU.
Time frame
Early acute phase of critical illness, i.e., 24-72 hours after ICU admission. The difference between substrate kinetics at 165-180 min and 345-360 min after the start of the tracer infusion will be calculated.3
Attenuation of glycerol production in response to nutrition in early acute phase in ICU.
Difference in endogenous rate of appearance of glycerol, calculated from enrichment of labelled substrates in plasma of glycerol, between the fasted and fed states in the early acute phase in ICU.
Time frame
Early acute phase of critical illness, i.e., 24-72 hours after ICU admission. The difference between substrate kinetics at 165-180 min and 345-360 min after the start of the tracer infusion will be calculated.Secondary outcomes
1
Attenuation of glucose production in response to nutrition in the late acute phase compared to the early acute phase in the ICU.
Difference in endogenous rate of appearance, calculated from enrichment of labelled substrates in plasma glucose, between the fasted and fed state in the early acute phase, compared to the late acute phase in the ICU.
Time frame
The early acute phase is between 24 and 72 hours after ICU admission, and the late acute phase between 120 and 148 hours, i.e., 5-7 days after ICU admission.2
Attenuation of glycerol production in response to nutrition in the late acute phase compared to the early acute phase in the ICU.
Difference in endogenous rate of appearance, calculated from enrichment of labelled substrates in plasma glycerol, between the fasted and fed state in the early acute phase, compared to the late acute phase in the ICU.
Time frame
The early acute phase is between 24 and 72 hours after ICU admission, and the late acute phase between 120 and 148 hours, i.e., 5-7 days after ICU admission.3
Attenuation of phenylalanine production in response to nutrition in the late acute phase compared to the early acute phase in the ICU.
Difference in endogenous rate of appearance, calculated from enrichment of labelled substrates in plasma phenylalanine, between the fasted and fed state in the early acute phase, compared to the late acute phase in the ICU.
Time frame
The early acute phase is between 24 and 72 hours after ICU admission, and the late acute phase between 120 and 148 hours, i.e., 5-7 days after ICU admission.4
Attenuation of glucose production in response to nutrition in the early acute phase in the ICU compared to healthy controls.
Difference in endogenous rate of appearance, calculated from enrichment of labeled substrates in plasma of glucose between fasted and fed state in the early acute phase, compared to healthy controls.
Time frame
Early acute phase of critical illness, i.e., 24-72 hours after ICU admission. The difference between substrate kinetics at 165-180 min and 345-360 min after the start of the tracer infusion will be calculated.Other outcomes
1
Metabolomics
Within-group changes in ICU patients between the fasted and fed states of metabolomics. This will be compared between the early acute and the late acute phase.
Time frame
The early acute phase is between 24 and 72 hours after ICU admission, and the late acute phase is between 120 and 148 hours, i.e., 5-7 days after ICU admission.2
Attenuation of glucose production in response to nutrition in the late phase compared to the early acute phase in the ICU.
Difference in endogenous rate of appearance, calculated from enrichment of labelled substrates in plasma of glucose between fasted and fed states in the early acute phase, compared to the late phase in the ICU.
Time frame
The early acute phase is between 24 and 72 hours after ICU admission, and the late acute phase is more than 240 hours, i.e., 10 days after ICU admission.3
Attenuation of glycerol production in response to nutrition in the late phase compared to the early acute phase in the ICU.
Difference in endogenous rate of appearance, calculated from enrichment of labelled substrates in plasma of glycerol between fasted and fed states in the early acute phase, compared to the late phase in the ICU.
Time frame
The early acute phase is between 24 and 72 hours after ICU admission, and the late acute phase is more than 240 hours, i.e., 10 days after ICU admission.4
Attenuation of phenylalanine production in response to nutrition in the late phase compared to the early acute phase in the ICU.
Difference in endogenous rate of appearance, calculated from enrichment of labelled substrates in plasma of phanylalanine between fasted and fed states in the early acute phase, compared to the late phase in the ICU.
Time frame
The early acute phase is between 24 and 72 hours after ICU admission, and the late acute phase is more than 240 hours, i.e., 10 days after ICU admission.Sponsors and contacts
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Source ClinicalTrials.gov