NCT07024264

Brief Summary

The goal of this observational study is to compare energy requirements estimated by predictive equation and indirect calorimetry across different BMI categories, and to examine how these estimates, along with early nutritional strategies and progressive caloric delivery relate to ICU outcomes. The main questions it aims to answer are:

  1. 1.To evaluate whether predictive equation and/or indirect calorimetry provides accurate caloric targets in critically ill patients.
  2. 2.To identify high-risk malnutrition patients (underweight, normal and overweight, obese) who may benefit most from IC-based measurement.
  3. 3.To investigate the impact of caloric strategies and nutritional achievement during the acute phase on the length of ICU stay.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
133

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 14, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 17, 2025

Completed
Last Updated

June 17, 2025

Status Verified

October 1, 2024

Enrollment Period

1.5 years

First QC Date

May 14, 2025

Last Update Submit

June 12, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • The primary outcome was ICU length of stay.

    This study aimed to compare energy requirements estimated by PE and IC across different BMI categories, and to examine how these estimates, along with early nutritional strategies and progressive caloric delivery relate to the length of ICU stay.

    From admitted to ICU which defined as day 1, until transferred to the general wards or expired, up to 12 weeks.

Interventions

Critically ill patients are highly susceptible to malnutrition, making accurate caloric estimation essential to prevent both underfeeding and overfeeding during the acute phase in the ICU. Although predictive equations (PE) are widely used to estimate energy requirement, indirect calorimetry (IC) remains the gold standard. This study aimed to compare energy requirements estimated by PE and IC across different BMI categories.

Eligibility Criteria

Age20 Years - 105 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to ICU and ventilator dependent in Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare.

You may qualify if:

  • Length of ICU stay \> 4 days
  • Mechanically ventilated adults (\>20 y/o)
  • Tube feeding
  • At high risk of malnutrition by Global Leadership Initiative on Malnutrition (GLIM) criteria: underweight and obesity
  • Doctor's preference: cachexia, hypermetabolic status, TPN etc.,…

You may not qualify if:

  • Length of ICU stay \<4 days
  • Mechanically ventilated adults (\<=20 y/o)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare

New Taipei City, Taiwan

Location

Related Publications (4)

  • McClave SA, Taylor BE, Martindale RG, Warren MM, Johnson DR, Braunschweig C, McCarthy MS, Davanos E, Rice TW, Cresci GA, Gervasio JM, Sacks GS, Roberts PR, Compher C; Society of Critical Care Medicine; American Society for Parenteral and Enteral Nutrition. Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient: Society of Critical Care Medicine (SCCM) and American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.). JPEN J Parenter Enteral Nutr. 2016 Feb;40(2):159-211. doi: 10.1177/0148607115621863. No abstract available.

    PMID: 26773077BACKGROUND
  • Singer P, Blaser AR, Berger MM, Alhazzani W, Calder PC, Casaer MP, Hiesmayr M, Mayer K, Montejo JC, Pichard C, Preiser JC, van Zanten ARH, Oczkowski S, Szczeklik W, Bischoff SC. ESPEN guideline on clinical nutrition in the intensive care unit. Clin Nutr. 2019 Feb;38(1):48-79. doi: 10.1016/j.clnu.2018.08.037. Epub 2018 Sep 29.

    PMID: 30348463BACKGROUND
  • De Waele E, Jonckheer J, Wischmeyer PE. Indirect calorimetry in critical illness: a new standard of care? Curr Opin Crit Care. 2021 Aug 1;27(4):334-343. doi: 10.1097/MCC.0000000000000844.

    PMID: 33990505BACKGROUND
  • Zusman O, Theilla M, Cohen J, Kagan I, Bendavid I, Singer P. Resting energy expenditure, calorie and protein consumption in critically ill patients: a retrospective cohort study. Crit Care. 2016 Nov 10;20(1):367. doi: 10.1186/s13054-016-1538-4.

    PMID: 27832823BACKGROUND

MeSH Terms

Conditions

Critical IllnessMalnutrition

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2025

First Posted

June 17, 2025

Study Start

October 1, 2022

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

June 17, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations