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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
A Longitudinal Investigation of Energy Expenditure and Substrate Utilization in Critically Ill Patients: a Prospective Observational Multi-center Study
Secondary ID [1] 0 0
K 2021-6909
Universal Trial Number (UTN)
Trial acronym
EPIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical Illness 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Diagnosis / Prognosis - Indirect calorimetry

Diagnosis / Prognosis: Indirect calorimetry
Measurement of metabolic rate (kcal/day) by respiratory gas analysis.
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in resting energy expenditure over time in patients who stay in ICU for >10 days.
Timepoint [1] 0 0
From date of ICU admission to the date of ICU discharge or death, whichever came first, assessed up to 24 months.
Secondary outcome [1] 0 0
Change in respiratory quotient over time in patients who stay in ICU for >10 days.
Timepoint [1] 0 0
From date of ICU admission to the date of ICU discharge or death, whichever came first, assessed up to 24 months.
Secondary outcome [2] 0 0
Change in resting energy expenditure (kcal/kg/day) over time in patients who stay in ICU for =10 days.
Timepoint [2] 0 0
From date of ICU admission to the date of ICU discharge or death, whichever came first, assessed up to 24 months.
Secondary outcome [3] 0 0
Change in respiratory quotient over time in patients who stay in ICU for =10 days.
Timepoint [3] 0 0
From date of ICU admission to the date of ICU discharge or death, whichever came first, assessed up to 24 months.

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2024
Actual
Sample size
Target
1250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [2] 0 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Netherlands
State/province [1] 0 0
Ede
Country [2] 0 0
Sweden
State/province [2] 0 0
Stockholm
Country [3] 0 0
Sweden
State/province [3] 0 0
Örebro
Country [4] 0 0
Switzerland
State/province [4] 0 0
Lucerne

Funding & Sponsors
Primary sponsor type
Other
Name
Karolinska University Hospital
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Karolinska Institutet
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT05124860
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.
Public notes

Contacts
Principal investigator
Name 0 0
Martin Sundström Rehal, MD PhD
Address 0 0
Karolinska University Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Martin Sundström Rehal, MD PhD
Address 0 0
Country 0 0
Phone 0 0
08-58580000
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05124860