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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05124860
Registration number
NCT05124860
Ethics application status
Date submitted
25/10/2021
Date registered
18/11/2021
Date last updated
7/03/2024
Titles & IDs
Public title
A Longitudinal Investigation of Energy Expenditure and Substrate Utilization in Critically Ill Patients
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Scientific title
A Longitudinal Investigation of Energy Expenditure and Substrate Utilization in Critically Ill Patients: a Prospective Observational Multi-center Study
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Secondary ID [1]
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K 2021-6909
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Universal Trial Number (UTN)
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Trial acronym
EPIC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Critical Illness
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Diagnosis / Prognosis - Indirect calorimetry
Diagnosis / Prognosis: Indirect calorimetry
Measurement of metabolic rate (kcal/day) by respiratory gas analysis.
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Intervention code [1]
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Diagnosis / Prognosis
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in resting energy expenditure over time in patients who stay in ICU for >10 days.
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Assessment method [1]
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Kcal/kg adjusted body weight/24 hours.
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Timepoint [1]
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From date of ICU admission to the date of ICU discharge or death, whichever came first, assessed up to 24 months.
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Secondary outcome [1]
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Change in respiratory quotient over time in patients who stay in ICU for >10 days.
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Assessment method [1]
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Quotient of carbon dioxide production and oxygen consumption.
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Timepoint [1]
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From date of ICU admission to the date of ICU discharge or death, whichever came first, assessed up to 24 months.
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Secondary outcome [2]
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Change in resting energy expenditure (kcal/kg/day) over time in patients who stay in ICU for =10 days.
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Assessment method [2]
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Kcal/kg adjusted body weight/24 hours.
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Timepoint [2]
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From date of ICU admission to the date of ICU discharge or death, whichever came first, assessed up to 24 months.
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Secondary outcome [3]
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Change in respiratory quotient over time in patients who stay in ICU for =10 days.
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Assessment method [3]
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Quotient of carbon dioxide production and oxygen consumption.
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Timepoint [3]
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From date of ICU admission to the date of ICU discharge or death, whichever came first, assessed up to 24 months.
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Eligibility
Key inclusion criteria
1. >/= 18 years old.
2. Admitted to the ICU of a participating study site.
3. At least one measurement of energy expenditure performed during ICU stay.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Patients readmitted to the ICU of a participating study site >72 hours after ICU
discharge and already included in the study (=1 measurement of energy expenditure
performed during prior admission). If a patient is readmitted within =72 hours of ICU
discharge this is considered a continuation of the last ICU admission for the purposes
of this study.
2. Burns >20% of body surface area.
3. Pregnancy.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/02/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/07/2024
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Actual
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Sample size
Target
1250
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Royal Melbourne Hospital - Melbourne
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Recruitment hospital [2]
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The Alfred - Melbourne
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Recruitment postcode(s) [1]
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- Melbourne
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Recruitment outside Australia
Country [1]
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Netherlands
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State/province [1]
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Ede
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Country [2]
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Sweden
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State/province [2]
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Stockholm
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Country [3]
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Sweden
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State/province [3]
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Örebro
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Country [4]
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Switzerland
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State/province [4]
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Lucerne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Karolinska University Hospital
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Karolinska Institutet
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The metabolic alterations associated with critical illness have significant implications for
the nutritional management of ICU patients. Despite this, little is known about these changes
in patients requiring prolonged organ support and nutritional therapy.
The overall aim of this study is to describe changes in metabolism over time in a large
prospective cohort of patients requiring >10 days of ICU care. Our hypothesis is that there
is a significant change in mean energy expenditure and respiratory quotient (RQ) between the
early (day 1-3), intermediate (day 4-10) and late (>10 days) phase in ICU.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05124860
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Trial related presentations / publications
Preiser JC, Ichai C, Orban JC, Groeneveld AB. Metabolic response to the stress of critical illness. Br J Anaesth. 2014 Dec;113(6):945-54. doi: 10.1093/bja/aeu187. Epub 2014 Jun 26.
Iwashyna TJ, Hodgson CL, Pilcher D, Bailey M, van Lint A, Chavan S, Bellomo R. Timing of onset and burden of persistent critical illness in Australia and New Zealand: a retrospective, population-based, observational study. Lancet Respir Med. 2016 Jul;4(7):566-573. doi: 10.1016/S2213-2600(16)30098-4. Epub 2016 May 4.
Haines RW, Zolfaghari P, Wan Y, Pearse RM, Puthucheary Z, Prowle JR. Elevated urea-to-creatinine ratio provides a biochemical signature of muscle catabolism and persistent critical illness after major trauma. Intensive Care Med. 2019 Dec;45(12):1718-1731. doi: 10.1007/s00134-019-05760-5. Epub 2019 Sep 17.
Nakamura K, Ogura K, Nakano H, Naraba H, Takahashi Y, Sonoo T, Hashimoto H, Morimura N. C-reactive protein clustering to clarify persistent inflammation, immunosuppression and catabolism syndrome. Intensive Care Med. 2020 Mar;46(3):437-443. doi: 10.1007/s00134-019-05851-3. Epub 2020 Jan 9.
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Public notes
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Contacts
Principal investigator
Name
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Martin Sundström Rehal, MD PhD
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Address
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Karolinska University Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Martin Sundström Rehal, MD PhD
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Address
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Country
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Phone
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08-58580000
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05124860
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