
==== Front
Indian J Crit Care Med
Indian J Crit Care Med
IJCCM
Indian Journal of Critical Care Medicine : Peer-reviewed, Official Publication of Indian Society of Critical Care Medicine
0972-5229
1998-359X
Jaypee Brothers Medical Publishers

10.5005/jp-journals-10071-24759
Letter to the Editor
Emphasizing Patient-centered Outcomes and Improved Exclusion Criteria in Randomized Controlled Trials for Clinical Nutrition in Critically Ill Patients
Sundarsingh Vijay 1https://orcid.org/0009-0009-3303-2328

Kumar Manoj 2https://orcid.org/0000-0002-4990-3708

1 Department of Critical Care Medicine, Father Muller Medical College, Mangaluru, Karnataka, India
2 Department of Anaesthesiology, Father Muller Medical College, Mangaluru, Karnataka, India
Vijay Sundarsingh, Department of Critical Care Medicine, Father Muller Medical College, Mangaluru, Karnataka, India, Phone: +91 8072952625, e-mail: vijayss87pm@gmail.com
8 2024
31 7 2024
28 8 804805
Copyright © 2024; The Author(s).
2024
https://creativecommons.org/licenses/by-nc/4.0/ © The Author(s). 2024 Open Access. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by-nc/4.0/), which permits unrestricted use, distribution, and non-commercial reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
How to cite this article: Sundarsingh V, Kumar M. Emphasizing Patient-centered Outcomes and Improved Exclusion Criteria in Randomized Controlled Trials for Clinical Nutrition in Critically Ill Patients. Indian J Crit Care Med 2024;28(8):804–805.

Keywords

Bias
Indirect calorimetry
Nutrition
Quadriceps muscle thickness
Randomized controlled trial
==== Body
pmc Dear Editor,

We are writing to express our thoughts on the recent study comparing indirect calorimetry (IC) and weight-based equation-guided nutrition's effect on quadriceps muscle thickness (QMT) in ICU patients, by Chandrasekaran et al.1 The research provides valuable insights into the nutritional management of critically ill patients. However, several aspects warrant further discussion and consideration.

Firstly, the study did not include patient-centered outcomes. Patient important outcomes and care provider decision-making outcomes such as mortality, quality of life, functional outcomes (ICU acquired weakness) assessed at ICU discharge, mechanical ventilation duration, and length of stay will add more to clinical decision-making than relying solely on surrogate outcome measures like laboratory and radiological outcomes, etc.2 While the reduction in QMT is a significant measure, reporting patient-important outcomes as well would have made it easier to interpret the clinical utility of these results.

Secondly, we feel that patients whose IC and QMT measurements could have been influenced by their prior functional status and organ supports received in the ICU were not excluded, such as patients who stayed in the hospital for more than five days and those who did not ambulate before ICU illness would have poor baseline muscle status. This exclusion is critical because the pre-ICU functional status can significantly impact the extent of muscle wasting observed. Furthermore, the exclusion of patients undergoing continuous renal replacement therapy (CRRT) or extracorporeal membrane oxygenation (ECMO) was not mentioned. In CRRT, the measured resting energy expenditure (REE) will not reflect the patient's REE, as it affects the respiratory pattern due to CO2 removal. Patients on ECMO need gas exchange analysis by IC on both the ventilator and ECMO sides.3

Thirdly, our concern is the lack of blinding in the study. Bias in an randomized controlled trial (RCT) is avoided not only by randomization but also by blinding. Blinding is essential to minimize the influence of subjective biases on outcome assessment and intervention administration. The absence of blinding could have affected the interpretation of QMT measurements.

Fourthly, the study did not report adverse effects associated with nutritional interventions as guided by IC vs weight-based equation such as feed intolerance, metabolic derangements, and variations in insulin requirements. Reporting these adverse effects is essential in an RCT to fully understand the safety profile of the interventions and to make informed clinical decisions.4

Lastly, the conclusion of the study seems to be overstated. The authors claim that IC-based nutrition reduces sarcopenia in critically ill patients. However, sarcopenia is a complex condition characterized not only by muscle loss but also by decreased muscle function, which was not assessed in this study. Therefore, a more appropriate conclusion would be that IC-based nutrition reduces muscle wasting rather than definitively concluding a reduction in sarcopenia.

We appreciate the valuable insights provided by the study on IC-based nutrition and QMT in ICU patients. However, incorporating patient-centered outcomes, excluding certain patient groups, ensuring blinding, and reporting adverse effects would enhance the study's clinical applicability and accuracy of conclusions.

Orcid

Vijay Sundarsingh https://orcid.org/0009-0009-3303-2328

Manoj Kumar https://orcid.org/0000-0002-4990-3708

Source of support: Nil

Conflict of interest: None
==== Refs
References

1. Chandrasekaran A Pal D Harne R Patel SJ Jagadeesh KN Pachisia AV et al. Comparison between effect of indirect calorimetry vs weight-based equation (25 kcal/kg/day)-guided nutrition on quadriceps muscle thickness as assessed by bedside ultrasonography in medical intensive care unit patients: A randomized clinical trial Indian J Crit Care Med 2024 28 6 587 594 10.5005/jp-journals-10071-24737 39130394
2. Gaudry S Messika J Ricard JD Guillo S Pasquet B Dubief E et al. Patient-important outcomes in randomized controlled trials in critically ill patients: A systematic review Ann Intensive Care 2017 7 1 28 10.1186/s13613-017-0243-z 28271450
3. Delsoglio M Achamrah N Berger MM Pichard C Indirect calorimetry in clinical practice J Clin Med 2019 8 9 1387 10.3390/jcm8091387 31491883
4. Kabisch M Ruckes C Seibert-Grafe M Blettner M Randomized controlled trials: Part 17 of a series on evaluation of scientific publications Dtsch Arztebl Int 2011 108 39 663 668 10.3238/arztebl.2011.0663 22013494
