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Individualised versus conventional glucose control in critically-ill patients: the CONTROLING study—a randomized clinical trial

PURPOSE: Hyperglycaemia is an adaptive response to stress commonly observed in critical illness. Its management remains debated in the intensive care unit (ICU). Individualising hyperglycaemia management, by targeting the patient’s pre-admission usual glycaemia, could improve outcome. METHODS: In a...

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Autores principales: Bohé, Julien, Abidi, Hassane, Brunot, Vincent, Klich, Amna, Klouche, Kada, Sedillot, Nicholas, Tchenio, Xavier, Quenot, Jean-Pierre, Roudaut, Jean-Baptiste, Mottard, Nicolas, Thiollière, Fabrice, Dellamonica, Jean, Wallet, Florent, Souweine, Bertrand, Lautrette, Alexandre, Preiser, Jean-Charles, Timsit, Jean-François, Vacheron, Charles-Hervé, Ait Hssain, Ali, Maucort-Boulch, Delphine
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8550173/
https://www.ncbi.nlm.nih.gov/pubmed/34590159
http://dx.doi.org/10.1007/s00134-021-06526-8
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author Bohé, Julien
Abidi, Hassane
Brunot, Vincent
Klich, Amna
Klouche, Kada
Sedillot, Nicholas
Tchenio, Xavier
Quenot, Jean-Pierre
Roudaut, Jean-Baptiste
Mottard, Nicolas
Thiollière, Fabrice
Dellamonica, Jean
Wallet, Florent
Souweine, Bertrand
Lautrette, Alexandre
Preiser, Jean-Charles
Timsit, Jean-François
Vacheron, Charles-Hervé
Ait Hssain, Ali
Maucort-Boulch, Delphine
author_facet Bohé, Julien
Abidi, Hassane
Brunot, Vincent
Klich, Amna
Klouche, Kada
Sedillot, Nicholas
Tchenio, Xavier
Quenot, Jean-Pierre
Roudaut, Jean-Baptiste
Mottard, Nicolas
Thiollière, Fabrice
Dellamonica, Jean
Wallet, Florent
Souweine, Bertrand
Lautrette, Alexandre
Preiser, Jean-Charles
Timsit, Jean-François
Vacheron, Charles-Hervé
Ait Hssain, Ali
Maucort-Boulch, Delphine
author_sort Bohé, Julien
collection PubMed
description PURPOSE: Hyperglycaemia is an adaptive response to stress commonly observed in critical illness. Its management remains debated in the intensive care unit (ICU). Individualising hyperglycaemia management, by targeting the patient’s pre-admission usual glycaemia, could improve outcome. METHODS: In a multicentre, randomized, double-blind, parallel-group study, critically-ill adults were considered for inclusion. Patients underwent until ICU discharge either individualised glucose control by targeting the pre-admission usual glycaemia using the glycated haemoglobin A1c level at ICU admission (IC group), or conventional glucose control by maintaining glycaemia below 180 mg/dL (CC group). A non-commercial web application of a dynamic sliding-scale insulin protocol gave to nurses all instructions for glucose control in both groups. The primary outcome was death within 90 days. RESULTS: Owing to a low likelihood of benefit and evidence of the possibility of harm related to hypoglycaemia, the study was stopped early. 2075 patients were randomized; 1917 received the intervention, 942 in the IC group and 975 in the CC group. Although both groups showed significant differences in terms of glycaemic control, survival probability at 90-day was not significantly different (IC group: 67.2%, 95% CI [64.2%; 70.3%]; CC group: 69.6%, 95% CI [66.7%; 72.5%]). Severe hypoglycaemia (below 40 mg/dL) occurred in 3.9% of patients in the IC group and in 2.5% of patients in the CC group (p = 0.09). A post hoc analysis showed for non-diabetic patients a higher risk of 90-day mortality in the IC group compared to the CC group (HR 1.3, 95% CI [1.05; 1.59], p = 0.018). CONCLUSION: Targeting an ICU patient’s pre-admission usual glycaemia using a dynamic sliding-scale insulin protocol did not demonstrate a survival benefit compared to maintaining glycaemia below 180 mg/dL. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s00134-021-06526-8.
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spelling pubmed-85501732021-10-29 Individualised versus conventional glucose control in critically-ill patients: the CONTROLING study—a randomized clinical trial Bohé, Julien Abidi, Hassane Brunot, Vincent Klich, Amna Klouche, Kada Sedillot, Nicholas Tchenio, Xavier Quenot, Jean-Pierre Roudaut, Jean-Baptiste Mottard, Nicolas Thiollière, Fabrice Dellamonica, Jean Wallet, Florent Souweine, Bertrand Lautrette, Alexandre Preiser, Jean-Charles Timsit, Jean-François Vacheron, Charles-Hervé Ait Hssain, Ali Maucort-Boulch, Delphine Intensive Care Med Original PURPOSE: Hyperglycaemia is an adaptive response to stress commonly observed in critical illness. Its management remains debated in the intensive care unit (ICU). Individualising hyperglycaemia management, by targeting the patient’s pre-admission usual glycaemia, could improve outcome. METHODS: In a multicentre, randomized, double-blind, parallel-group study, critically-ill adults were considered for inclusion. Patients underwent until ICU discharge either individualised glucose control by targeting the pre-admission usual glycaemia using the glycated haemoglobin A1c level at ICU admission (IC group), or conventional glucose control by maintaining glycaemia below 180 mg/dL (CC group). A non-commercial web application of a dynamic sliding-scale insulin protocol gave to nurses all instructions for glucose control in both groups. The primary outcome was death within 90 days. RESULTS: Owing to a low likelihood of benefit and evidence of the possibility of harm related to hypoglycaemia, the study was stopped early. 2075 patients were randomized; 1917 received the intervention, 942 in the IC group and 975 in the CC group. Although both groups showed significant differences in terms of glycaemic control, survival probability at 90-day was not significantly different (IC group: 67.2%, 95% CI [64.2%; 70.3%]; CC group: 69.6%, 95% CI [66.7%; 72.5%]). Severe hypoglycaemia (below 40 mg/dL) occurred in 3.9% of patients in the IC group and in 2.5% of patients in the CC group (p = 0.09). A post hoc analysis showed for non-diabetic patients a higher risk of 90-day mortality in the IC group compared to the CC group (HR 1.3, 95% CI [1.05; 1.59], p = 0.018). CONCLUSION: Targeting an ICU patient’s pre-admission usual glycaemia using a dynamic sliding-scale insulin protocol did not demonstrate a survival benefit compared to maintaining glycaemia below 180 mg/dL. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s00134-021-06526-8. Springer Berlin Heidelberg 2021-09-29 2021 /pmc/articles/PMC8550173/ /pubmed/34590159 http://dx.doi.org/10.1007/s00134-021-06526-8 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by-nc/4.0/Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Original
Bohé, Julien
Abidi, Hassane
Brunot, Vincent
Klich, Amna
Klouche, Kada
Sedillot, Nicholas
Tchenio, Xavier
Quenot, Jean-Pierre
Roudaut, Jean-Baptiste
Mottard, Nicolas
Thiollière, Fabrice
Dellamonica, Jean
Wallet, Florent
Souweine, Bertrand
Lautrette, Alexandre
Preiser, Jean-Charles
Timsit, Jean-François
Vacheron, Charles-Hervé
Ait Hssain, Ali
Maucort-Boulch, Delphine
Individualised versus conventional glucose control in critically-ill patients: the CONTROLING study—a randomized clinical trial
title Individualised versus conventional glucose control in critically-ill patients: the CONTROLING study—a randomized clinical trial
title_full Individualised versus conventional glucose control in critically-ill patients: the CONTROLING study—a randomized clinical trial
title_fullStr Individualised versus conventional glucose control in critically-ill patients: the CONTROLING study—a randomized clinical trial
title_full_unstemmed Individualised versus conventional glucose control in critically-ill patients: the CONTROLING study—a randomized clinical trial
title_short Individualised versus conventional glucose control in critically-ill patients: the CONTROLING study—a randomized clinical trial
title_sort individualised versus conventional glucose control in critically-ill patients: the controling study—a randomized clinical trial
topic Original
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8550173/
https://www.ncbi.nlm.nih.gov/pubmed/34590159
http://dx.doi.org/10.1007/s00134-021-06526-8
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