Core outcome measures for clinical effectiveness trials of nutritional and metabolic interventions in critical illness: an international modified Delphi consensus study evaluation (CONCISE)

Davies, Teifion; Gassel, Rob J. J. van; Poll, Marcel van de; Gunst, Jan; Casaer, Michaël P; Christopher, Kenneth B.; Preiser, Jean‐Charles; Hill, Aileen; Gündoğan, Kürşat; Blaser, Annika Reintam; Rousseau, A.; Hodgson, Carol; Needham, Dale M.; Castro, Martha Moreira Cavalcante; Schaller, Stefan J.; McClelland, Thomas J; Pilkington, Jeffrey J.; Sevin, Carla M.; Wischmeyer, Paul E.; Lee, Z. Y.; Govil, Deepak; Li, A.; Chapple, Lee‐anne S.; Denehy, Linda; Montejo-González, Juan Carlos; Taylor, Briana J.; Bear, Danielle E.; Pearse, Rupert M.; McNelly, Angela; Prowle, John R.; Puthucheary, Zudin

doi:10.1186/s13054-022-04113-x

Cited by 37 publications

(41 citation statements)

References 46 publications

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“…Finally, the studies inconsistency in assessing outcomes made a meta-analysis of outcomes associated with muscle wasting not possible. The recent CONCISE Delphi consensus should provide further guidance for authors assessing outcomes related to muscle wasting [ 74 ].…”

Section: Discussionmentioning

confidence: 99%

The rate and assessment of muscle wasting during critical illness: a systematic review and meta-analysis

et al. 2023

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Background Patients with critical illness can lose more than 15% of muscle mass in one week, and this can have long-term detrimental effects. However, there is currently no synthesis of the data of intensive care unit (ICU) muscle wasting studies, so the true mean rate of muscle loss across all studies is unknown. The aim of this project was therefore to systematically synthetise data on the rate of muscle loss and to identify the methods used to measure muscle size and to synthetise data on the prevalence of ICU-acquired weakness in critically ill patients. Methods We conducted a systematic literature search of MEDLINE, PubMed, AMED, BNI, CINAHL, and EMCARE until January 2022 (International Prospective Register of Systematic Reviews [PROSPERO] registration: CRD420222989540. We included studies with at least 20 adult critically ill patients where the investigators measured a muscle mass-related variable at two time points during the ICU stay. We followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and assessed the study quality using the Newcastle–Ottawa Scale. Results Fifty-two studies that included 3251 patients fulfilled the selection criteria. These studies investigated the rate of muscle wasting in 1773 (55%) patients and assessed ICU-acquired muscle weakness in 1478 (45%) patients. The methods used to assess muscle mass were ultrasound in 85% (n = 28/33) of the studies and computed tomography in the rest 15% (n = 5/33). During the first week of critical illness, patients lost every day −1.75% (95% CI −2.05, −1.45) of their rectus femoris thickness or −2.10% (95% CI −3.17, −1.02) of rectus femoris cross-sectional area. The overall prevalence of ICU-acquired weakness was 48% (95% CI 39%, 56%). Conclusion On average, critically ill patients lose nearly 2% of skeletal muscle per day during the first week of ICU admission.

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Section: Discussionmentioning

confidence: 99%

The rate and assessment of muscle wasting during critical illness: a systematic review and meta-analysis

et al. 2023

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“…A growing number of articles in the literature insists on the relevance of nutritional support beyond the acute phase and the ICU stay [ 69 , 70 ]. The definition of core outcomes for ICU nutritional trials now makes it possible to guide the choice of outcomes and to facilitate the comparison and interpretation of results [ 71 ]. Last, we did not report the energy requirements estimated by indirect calorimetry for our cohort, though this is recommended by the latest European Guidelines [ 14 ].…”

Section: Discussionmentioning

confidence: 99%

Association between early nutrition support and 28-day mortality in critically ill patients: the FRANS prospective nutrition cohort study

et al. 2023

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Background Current guidelines suggest the introduction of early nutrition support within the first 48 h of admission to the intensive care unit (ICU) for patients who cannot eat. In that context, we aimed to describe nutrition practices in the ICU and study the association between the introduction of early nutrition support (< 48 h) in the ICU and patient mortality at day 28 (D28) using data from a multicentre prospective cohort. Methods The ‘French-Speaking ICU Nutritional Survey’ (FRANS) study was conducted in 26 ICUs in France and Belgium over 3 months in 2015. Adult patients with a predicted ICU length of stay > 3 days were consecutively included and followed for 10 days. Their mortality was assessed at D28. We investigated the association between early nutrition (< 48 h) and mortality at D28 using univariate and multivariate propensity-score-weighted logistic regression analyses. Results During the study period, 1206 patients were included. Early nutrition support was administered to 718 patients (59.5%), with 504 patients receiving enteral nutrition and 214 parenteral nutrition. Early nutrition was more frequently prescribed in the presence of multiple organ failure and less frequently in overweight and obese patients. Early nutrition was significantly associated with D28 mortality in the univariate analysis (crude odds ratio (OR) 1.69, 95% confidence interval (CI) 1.23–2.34) and propensity-weighted multivariate analysis (adjusted OR (aOR) 1.05, 95% CI 1.00–1.10). In subgroup analyses, this association was stronger in patients ≤ 65 years and with SOFA scores ≤ 8. Compared with no early nutrition, a significant association was found of D28 mortality with early enteral (aOR 1.06, 95% CI 1.01–1.11) but not early parenteral nutrition (aOR 1.04, 95% CI 0.98–1.11). Conclusions In this prospective cohort study, early nutrition support in the ICU was significantly associated with increased mortality at D28, particularly in younger patients with less severe disease. Compared to no early nutrition, only early enteral nutrition appeared to be associated with increased mortality. Such findings are in contrast with current guidelines on the provision of early nutrition support in the ICU and may challenge our current practices, particularly concerning patients at low nutrition risk. Trial registration ClinicalTrials.gov Identifier: NCT02599948. Retrospectively registered on November 5th 2015.

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“…This positive impact of indirect calorimetry needs to be confirmed in further large studies in ICU, but also in post-ICU settings. The appropriate outcomes for nutrition studies have recently been defined in a core outcome set [ 30 ].…”

Section: Discussionmentioning

confidence: 99%

Measured Energy Expenditure Using Indirect Calorimetry in Post-Intensive Care Unit Hospitalized Survivors: A Comparison with Predictive Equations

et al. 2022

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Actual energy needs after a stay in intensive care units (ICUs) are unknown. The aims of this observational study were to measure the energy expenditure (mEE) of ICU survivors during their post-ICU hospitalization period, and to compare this to the estimations of predictive equations (eEE). Survivors of an ICU stay ≥ 7 days were enrolled in the general ward during the first 7 days after ICU discharge. EE was measured using the Q-NRG calorimeter in canopy mode. This measure was compared to the estimated EE using the Harris–Benedict (HB) equation multiplied by a 1.3 stress factor, the Penn–State (PS) equation or the 30 kcal weight-based (WB) equation. A total of 55 adults were included (67.3% male, age 60 (52–67) y, body mass index 26.1 (22.2–29.7) kg/m2). Indirect calorimetry was performed 4 (3–6) d after an ICU stay of 12 (7–16) d. The mEE was 1682 (1328–1975) kcal/d, corresponding to 22.9 (19.1–24.2) kcal/kg/day. The eEE values derived using HB and WB equations were significantly higher than mEE: 3048 (1805–3332) and 2220 (1890–2640) kcal/d, respectively (both p < 0.001). There was no significant difference between mEE and eEE using the PS equation: 1589 (1443–1809) kcal/d (p = 0.145). The PS equation tended to underestimate mEE with a bias of −61.88 kcal and a wide 95% limit of agreement (−717.8 to 594 kcal). Using the PS equation, agreement within 15% of the mEE was found in 32/55 (58.2%) of the patients. In the present cohort of patients who survived a prolonged ICU stay, mEE was around 22–23 kcal/kg/day. In this post-ICU hospitalization context, none of the tested equations were accurate in predicting the EE measured by indirect calorimetry.

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Core outcome measures for clinical effectiveness trials of nutritional and metabolic interventions in critical illness: an international modified Delphi consensus study evaluation (CONCISE)

Cited by 37 publications

References 46 publications

The rate and assessment of muscle wasting during critical illness: a systematic review and meta-analysis

The rate and assessment of muscle wasting during critical illness: a systematic review and meta-analysis

Association between early nutrition support and 28-day mortality in critically ill patients: the FRANS prospective nutrition cohort study

Measured Energy Expenditure Using Indirect Calorimetry in Post-Intensive Care Unit Hospitalized Survivors: A Comparison with Predictive Equations

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