A Longitudinal Investigation of Energy Expenditure and Substrate Utilization in Critically Ill Patients

NCT05124860 | Completed

• 1 other identifier: K 2021-6909
• Study Type: observational
• Target: 714
• Locations: 4 countries
• Sites: 7

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.

Conditions

Critical Illness

Keywords

Energy expenditure; Indirect calorimetry; Metabolism; Prolonged critical illness

Outcome Measures

Primary Outcomes (1)

• Change in resting energy expenditure over time in patients who stay in ICU for >10 days.

  Kcal/kg adjusted body weight/24 hours.

  From date of ICU admission to the date of ICU discharge or death, whichever came first, assessed up to 24 months.

Secondary Outcomes (3)

• Change in respiratory quotient over time in patients who stay in ICU for >10 days.

  From date of ICU admission to the date of ICU discharge or death, whichever came first, assessed up to 24 months.

• Change in resting energy expenditure (kcal/kg/day) over time in patients who stay in ICU for ≤10 days.

  From date of ICU admission to the date of ICU discharge or death, whichever came first, assessed up to 24 months.

• Change in respiratory quotient over time in patients who stay in ICU for ≤10 days.

  From date of ICU admission to the date of ICU discharge or death, whichever came first, assessed up to 24 months.

Other Outcomes (1)

• Correlations between energy expenditure/respiratory quotient and markers of inflammation, protein catabolism, antecedent characteristics and outcomes.

  From date of ICU admission to the date of ICU discharge or death, whichever came first, assessed up to 24 months.

Interventions

Indirect calorimetry DIAGNOSTIC_TEST

Measurement of metabolic rate (kcal/day) by respiratory gas analysis.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult intensive care unit patients with ≥1 measurement of energy expenditure by indirect calorimetry.

You may qualify if:

• \>/= 18 years old.
• Admitted to the ICU of a participating study site.
• At least one measurement of energy expenditure performed during ICU stay.

You may not qualify if:

• 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.
• Burns \>20% of body surface area.
• Pregnancy.

Sponsors & Collaborators

• Karolinska University Hospital: lead
• Karolinska Institutet: collaborator

Study Sites (7)

Royal Melbourne Hospital

Melbourne, Australia

Location

The Alfred

Melbourne, Australia

Location

Gelderse Vallei Hospital

Ede, Netherlands

Location

Karolinska University Hospital

Huddinge, Stockholm County, 14186, Sweden

Location

Universitetssjukhuset Örebro

Örebro, Sweden

Location

Capio S:t Görans Sjukhus

Stockholm, Sweden

Location

Lucerne Cantonal Hospital

Lucerne, Switzerland

Location

Related Publications (4)

• 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.

  PMID: 24970271 BACKGROUND

• 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.

  PMID: 27155770 BACKGROUND

• 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.

  PMID: 31531715 BACKGROUND

• 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.

  PMID: 31919541 BACKGROUND

Related Links

• Reporting on length of ICU stay 2015-2019 from the Swedish ICU Registry database.

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Martin Sundström Rehal, MD PhD

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

• Olav Rooyackers, PhD

  Karolinska Institutet

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 18, 2021
• Study Start: February 21, 2022
• Primary Completion: July 18, 2024
• Study Completion: March 21, 2025
• Last Updated: April 11, 2025

Record last verified: 2025-04

Locations

NL (1); CH (1); SE (3); AU (2)