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Article ; Online: Intraoperative protective mechanical ventilation in patients requiring emergency abdominal surgery

Samir Jaber / Emmanuel Futier / Karim Asehnoune / Bruno Pereira / Gerald Chanques / Justine Bourdier / Thomas Godet / Louisa Khaled / Lynda Araujo

BMJ Open, Vol 12, Iss

the multicentre prospective randomised IMPROVE-2 study protocol

2022 Volume 5

Keywords	Medicine ; R
Language	English
Publishing date	2022-05-01T00:00:00Z
Publisher	BMJ Publishing Group
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Association between proteinuria trajectories and outcomes in critically ill patients with sepsis or shock.

Raphael Monge / Charlotte Oris / Matthieu Jabaudon / Marina Braïlova / Emmanuel Futier / Vincent Sapin / Bruno Pereira / Alexandre Lautrette

PLoS ONE, Vol 17, Iss 8, p e

2022 Volume 0272835

Abstract: Background Proteinuria results from kidney damage and can be a predictor of illness severity and mortality in the intensive care unit (ICU). However, the optimal timing of proteinuria measurements and the reference values remain undetermined. Our ... ...

Abstract	Background Proteinuria results from kidney damage and can be a predictor of illness severity and mortality in the intensive care unit (ICU). However, the optimal timing of proteinuria measurements and the reference values remain undetermined. Our objective was to identify the patterns of proteinuria change associated with mortality in ICU patients with sepsis or shock. Methods This monocentric retrospective cohort study performed from April 2010 to April 2018 involved all ICU patients with sepsis or shock and at least two measurements of proteinuria from a 24h-urine collection during the first 10 days of ICU stay, the first of which was made within 48h after ICU admission. We identified proteinuria trajectories by a semi-parametric mixture model and analysed the association between the trajectories and the mortality at day 28 by Cox proportional-hazards model. Results A total of 3,344 measurements of proteinuria from 659 patients were analysed. Four proteinuria trajectories were identified. Trajectories 1, 2, 3 and 4 comprised 127, 421, 60 and 51 patients, and were characterized by a first proteinuria of 1.14 [0.66-1.55], 0.52 [0.26-0.91], 2.92 [2.38-3.84] and 2.58 [1.75-3.32] g/24h (p<0.001) and a mortality of 24.4%, 38%, 20% and 43% (p = 0.002), respectively. Trajectories 3 and 4 had a high first proteinuria (>2g/24h). Only, the proteinuria of trajectory 4 increased within 3 days following the first measurement and was associated with increased mortality at day 28 (hazard ratio: 2.36 95%CI [1.07-5.19], p = 0.03), regardless of acute renal failure. The factors associated with trajectory 4 were cancer (relative risk: 8.91 95%CI [2.09-38.02], p = 0.003) and use of inotropic drugs (relative risk: 0.17 95%CI [0.04-0.69], p = 0.01). Conclusion This exploratory study of ICU patients with sepsis or shock identified four proteinuria trajectories with distinct patterns of proteinuria change over time and mortality rates. These results provide novel insights into renal pathophysiology and may be helpful to ...
Keywords	Medicine ; R ; Science ; Q
Subject code	616 ; 610
Language	English
Publishing date	2022-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: A multivariate model for successful publication of intensive care medicine randomized controlled trials in the highest impact factor journals

Joris Pensier / Audrey De Jong / Gerald Chanques / Emmanuel Futier / Elie Azoulay / Nicolas Molinari / Samir Jaber

Annals of Intensive Care, Vol 11, Iss 1, Pp 1-

the SCOTI score

2021 Volume 11

Abstract: Abstract Background Critical care randomized controlled trials (RCTs) are often published in high-impact journals, whether general journals [the New England Journal of Medicine (NEJM), The Lancet, the Journal of the American Medical Association (JAMA)] ... ...

Abstract	Abstract Background Critical care randomized controlled trials (RCTs) are often published in high-impact journals, whether general journals [the New England Journal of Medicine (NEJM), The Lancet, the Journal of the American Medical Association (JAMA)] or critical care journals [Intensive Care Medicine (ICM), the American Journal of Respiratory and Critical Care Medicine (AJRCCM), Critical Care Medicine (CCM)]. As rejection occurs in up to 97% of cases, it might be appropriate to assess pre-submission probability of being published. The objective of this study was to develop and internally validate a simplified score predicting whether an ongoing trial stands a chance of being published in high-impact general journals. Methods A cohort of critical care RCTs published between 1999 and 2018 in the three highest impact medical journals (NEJM, The Lancet, JAMA) or the three highest impact critical care journals (ICM, AJRCCM, CCM) was split into two samples (derivation cohort, validation cohort) to develop and internally validate the simplified score. Primary outcome was journal of publication assessed as high-impact general journal (NEJM, The Lancet, JAMA) or critical care journal (ICM, AJRCCM, CCM). Results A total of 968 critical care RCTs were included in the predictive cohort and split into a derivation cohort (n = 510) and a validation cohort (n = 458). In the derivation cohort, the sample size (P value < 0.001), the number of centers involved (P value = 0.01), mortality as primary outcome (P value = 0.002) or a composite item including mortality as primary outcome (P value = 0.004), and topic [ventilation (P value < 0.001) or miscellaneous (P value < 0.001)] were independent factors predictive of publication in high-impact general journals, compared to high-impact critical care journals. The SCOTI score (Sample size, Centers, Outcome, Topic, and International score) was developed with an area under the ROC curve of 0.84 (95% Confidence Interval, 0.80–0.88) in validation by split sample. Conclusions ...
Keywords	Intensive care unit ; Critical care ; Critically ill patients ; Intensive care medicine ; Precision medicine ; Medical emergencies. Critical care. Intensive care. First aid ; RC86-88.9
Subject code	001 ; 050
Language	English
Publishing date	2021-11-01T00:00:00Z
Publisher	SpringerOpen
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Dexmedetomidine after Cardiac Surgery for Prevention of Delirium (EXACTUM) trial protocol

Emmanuel Futier / Thomas Kerforne / Sigismond Lasocki / Olivier Huet / Bertrand Rozec / Nicolas Nesseler / Dauphou Eddi / Thomas Gargadennec / Jean-Ferréol Oilleau / Julien Amour / Michel Durand / Adrien Bougle / Maëlys Consigny

BMJ Open, Vol 12, Iss

a multicentre randomised, double-blind, placebo-controlled trial

2022 Volume 4

Keywords	Medicine ; R
Language	English
Publishing date	2022-04-01T00:00:00Z
Publisher	BMJ Publishing Group
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Use of volatile agents for sedation in the intensive care unit

Raiko Blondonnet / Audrey Quinson / Céline Lambert / Jules Audard / Thomas Godet / Ruoyang Zhai / Bruno Pereira / Emmanuel Futier / Jean-Etienne Bazin / Jean-Michel Constantin / Matthieu Jabaudon

PLoS ONE, Vol 16, Iss 4, p e

A national survey in France.

2021 Volume 0249889

Abstract: Background Current intensive care unit (ICU) sedation guidelines recommend strategies using non-benzodiazepine sedatives. This survey was undertaken to explore inhaled ICU sedation practice in France. Methods In this national survey, medical directors of ...

Abstract	Background Current intensive care unit (ICU) sedation guidelines recommend strategies using non-benzodiazepine sedatives. This survey was undertaken to explore inhaled ICU sedation practice in France. Methods In this national survey, medical directors of French adult ICUs were contacted by phone or email between July and August 2019. ICU medical directors were questioned about the characteristics of their department, their knowledge on inhaled sedation, and practical aspects of inhaled sedation use in their department. Results Among the 374 ICUs contacted, 187 provided responses (50%). Most ICU directors (73%) knew about the use of inhaled ICU sedation and 21% used inhaled sedation in their unit, mostly with the Anaesthetic Conserving Device (AnaConDa, Sedana Medical). Most respondents had used volatile agents for sedation for <5 years (63%) and in <20 patients per year (75%), with their main indications being: failure of intravenous sedation, severe asthma or bronchial obstruction, and acute respiratory distress syndrome. Sevoflurane and isoflurane were mainly used (88% and 20%, respectively). The main reasons for not using inhaled ICU sedation were: "device not available" (40%), "lack of medical interest" (37%), "lack of familiarity or knowledge about the technique" (35%) and "elevated cost" (21%). Most respondents (80%) were overall satisfied with the use of inhaled sedation. Almost 75% stated that inhaled sedation was a seducing alternative to intravenous sedation. Conclusion This survey highlights the widespread knowledge about inhaled ICU sedation in France but shows its limited use to date. Differences in education and knowledge, as well as the recent and relatively scarce literature on the use of volatile agents in the ICU, might explain the diverse practices that were observed. The low rate of mild adverse effects, as perceived by respondents, and the users' satisfaction, are promising for this potentially important tool for ICU sedation.
Keywords	Medicine ; R ; Science ; Q
Subject code	310
Language	English
Publishing date	2021-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Changes in Plasma Soluble Receptor for Advanced Glycation End-Products Are Associated with Survival in Patients with Acute Respiratory Distress Syndrome

Matthieu Jabaudon / Bruno Pereira / Erwan Laroche / Laurence Roszyk / Raiko Blondonnet / Jules Audard / Thomas Godet / Emmanuel Futier / Jean-Etienne Bazin / Vincent Sapin / Julie A. Bastarache / Lorraine B. Ware / Jean-Michel Constantin / on behalf of the LIVE Study Group and the AZUREA Network

Journal of Clinical Medicine, Vol 10, Iss 2076, p

2021 Volume 2076

Abstract: The plasma soluble receptor for advanced glycation end-products (sRAGE) is a marker of lung epithelial injury with prognostic value when measured at baseline in acute respiratory distress syndrome (ARDS). However, whether changes in plasma sRAGE could ... ...

Abstract	The plasma soluble receptor for advanced glycation end-products (sRAGE) is a marker of lung epithelial injury with prognostic value when measured at baseline in acute respiratory distress syndrome (ARDS). However, whether changes in plasma sRAGE could inform prognosis in ARDS remains unknown. In this secondary analysis of the Lung Imaging for Ventilator Setting in ARDS (LIVE) multicenter randomized controlled trial, which evaluated a personalized ventilation strategy tailored to lung morphology, plasma sRAGE was measured upon study entry (baseline) and on days one, two, three, four and six. The association between changes in plasma sRAGE over time and 90-day survival was evaluated. Higher baseline plasma sRAGE (HR per-one log increment, 1.53; 95% CI, 1.16–2.03; p = 0.003) and an increase in sRAGE over time (HR for each one-log increment in plasma sRAGE per time unit, 1.01; 95% CI, 1.01–1.02; p < 10 −3 ) were both associated with increased 90-day mortality. Each 100-unit increase in the plasma sRAGE level per unit of time increased the risk of death at day 90 by 1% in joint modeling. Plasma sRAGE increased over time when a strategy of maximal alveolar recruitment was applied in patients with focal ARDS. Current findings suggest that the rate of change in plasma sRAGE over time is associated with 90-day survival and could be helpful as a surrogate outcome in ARDS.
Keywords	acute respiratory distress syndrome ; soluble RAGE ; biomarker ; joint modeling ; therapeutic response ; mechanical ventilation ; Medicine ; R
Subject code	610
Language	English
Publishing date	2021-05-01T00:00:00Z
Publisher	MDPI AG
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Impact of renin-angiotensin system inhibitors continuation versus discontinuation on outcome after major surgery

Matthieu Legrand / Emmanuel Futier / Marc Leone / Benjamin Deniau / Alexandre Mebazaa / Benoît Plaud / Pierre Coriat / Patrick Rossignol / Eric Vicaut / Etienne Gayat / for the STOP-OR-NOT study investigators

Trials, Vol 20, Iss 1, Pp 1-

protocol of a multicenter randomized, controlled trial (STOP-or-NOT trial)

2019 Volume 7

Abstract: Abstract Background Chronic treatment of hypertension or heart failure very often includes an angiotensin-converting enzyme inhibitors (ACE-Is) or angiotensin receptor blockers (ARBs) as renin-angiotensin system inhibitors (RASi) treatments. To stop or ... ...

Abstract	Abstract Background Chronic treatment of hypertension or heart failure very often includes an angiotensin-converting enzyme inhibitors (ACE-Is) or angiotensin receptor blockers (ARBs) as renin-angiotensin system inhibitors (RASi) treatments. To stop or not to stop these medications before major surgery remains an unresolved issue. The lack of evidence leads to conflicting guidelines with respect to RASi management before major surgery. The purpose of this study is to evaluate the impact of a strategy of RASi continuation or discontinuation on perioperative complications in patients undergoing major non-cardiac surgery. Methods This is a multicenter, open-labeled randomized controlled trial in > 30 French centers. In the experimental group, RASi will be continued while the treatment will be stopped 48 h before the surgery in the control arm. The primary endpoint is a composite endpoint of major complications after surgery. An endpoint adjudication committee will review clinical data and adjudicate efficacy endpoints while blinded to the assigned study drug group. Main analysis will be by intention-to-treat comparing the composite outcome measure at 28 days in the two groups. A total of 2222 patients are planned to detect an absolute complications difference of 5%. Discussion The results of the trial should provide robust evidence to anesthesiologists and surgeons regarding management of RASi before major non-cardiac surgery. Trial registration ClinicalTrials.gov, NCT03374449. Registered on 11 December 2017.
Keywords	ACE inhibitors ; ARB ; Strategy ; Outcome ; Complications ; Acute kidney injury ; Medicine (General) ; R5-920
Subject code	610
Language	English
Publishing date	2019-03-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Design and Rationale of the Sevoflurane for Sedation in Acute Respiratory Distress Syndrome (SESAR) Randomized Controlled Trial

Raiko Blondonnet / Laure-Anne Simand / Perine Vidal / Lucile Borao / Nathalie Bourguignon / Dominique Morand / Lise Bernard / Laurence Roszyk / Jules Audard / Thomas Godet / Antoine Monsel / Marc Garnier / Christophe Quesnel / Jean-Etienne Bazin / Vincent Sapin / Julie A. Bastarache / Lorraine B. Ware / Christopher G. Hughes / Pratik P. Pandharipande /

E. Wesley Ely / Emmanuel Futier / Bruno Pereira / Jean-Michel Constantin / Matthieu Jabaudon / on behalf of the SESAR Collaborative Group

Journal of Clinical Medicine, Vol 11, Iss 2796, p

2022 Volume 2796

Abstract: Preclinical studies have shown that volatile anesthetics may have beneficial effects on injured lungs, and pilot clinical data support improved arterial oxygenation, attenuated inflammation, and decreased lung epithelial injury in patients with acute ... ...

Abstract	Preclinical studies have shown that volatile anesthetics may have beneficial effects on injured lungs, and pilot clinical data support improved arterial oxygenation, attenuated inflammation, and decreased lung epithelial injury in patients with acute respiratory distress syndrome (ARDS) receiving inhaled sevoflurane compared to intravenous midazolam. Whether sevoflurane is effective in improving clinical outcomes among patients with ARDS is unknown, and the benefits and risks of inhaled sedation in ARDS require further evaluation. Here, we describe the SESAR (Sevoflurane for Sedation in ARDS) trial designed to address this question. SESAR is a two-arm, investigator-initiated, multicenter, prospective, randomized, stratified, parallel-group clinical trial with blinded outcome assessment designed to test the efficacy of sedation with sevoflurane compared to intravenous propofol in patients with moderate to severe ARDS. The primary outcome is the number of days alive and off the ventilator at 28 days, considering death as a competing event, and the key secondary outcome is 90 day survival. The planned enrollment is 700 adult participants at 37 French academic and non-academic centers. Safety and long-term outcomes will be evaluated, and biomarker measurements will help better understand mechanisms of action. The trial is funded by the French Ministry of Health, the European Society of Anaesthesiology, and Sedana Medical.
Keywords	acute respiratory distress syndrome ; sevoflurane ; inhaled sedation ; clinical trial ; Medicine ; R
Subject code	610
Language	English
Publishing date	2022-05-01T00:00:00Z
Publisher	MDPI AG
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Plasma levels of sRAGE, loss of aeration and weaning failure in ICU patients

Matthieu Jabaudon / Sébastien Perbet / Bruno Pereira / Alexis Soummer / Laurence Roszyk / Renaud Guérin / Emmanuel Futier / Qin Lu / Jean-Etienne Bazin / Vincent Sapin / Jean-Jacques Rouby / Jean-Michel Constantin

PLoS ONE, Vol 8, Iss 5, p e

a prospective observational multicenter study.

2013 Volume 64083

Abstract: Postextubation distress after a successful spontaneous breathing trial (SBT) is associated with increased morbidity and mortality. Lung ultrasound determination of changes in lung aeration predicts weaning failure. It remains unknown whether this ... ...

Abstract	Postextubation distress after a successful spontaneous breathing trial (SBT) is associated with increased morbidity and mortality. Lung ultrasound determination of changes in lung aeration predicts weaning failure. It remains unknown whether this derecruitment is related to alveolar epithelial dysfunction or not.To verify whether lung alveolar type I epithelial cell injury marker sRAGE (soluble form of the receptor for advanced glycation end-products) is predictive of postextubation distress and weaning failure or not, and to verify whether plasma sRAGE levels can be related to lung derecruitment during the process of weaning from mechanical ventilation or not. INTERVENTIONS MEASUREMENTS: 88 patients from 2 intensive care units were included in this observational prospective study. Plasma sRAGE levels were measured in duplicate by ELISA before, at the end of a 60-minute SBT, and 4 hours after extubation. To quantify lung aeration, a lung ultrasound score was calculated.34% of extubated patients experienced postextubation distress. Patients with or without postextubation distress had comparable sRAGE levels before SBT, after SBT, and 4 hours after extubation. In patients with postextubation distress, sRAGE levels were not predictive of the need for mechanical ventilation. sRAGE levels were not associated with lung aeration as assessed by echography. Patients who succeeded SBT (86%) and those who failed (14%) had no differences in sRAGE levels, before (median 1111 vs 1021 pg/mL, p = 0,87) and at the end of SBT (1165 vs 1038 pg/mL, p = 0.74).Plasma levels of sRAGE do not predict postextubation distress or SBT failure/success in patients weaning from mechanical ventilation. Lung aeration loss during a successful weaning trial predicts postextubation distress, but may not be evaluable by plasma levels of sRAGE, a marker of alveolar type I epithelial cell injury.ClinicalTrials.gov NCT01098773.
Keywords	Medicine ; R ; Science ; Q
Subject code	610
Language	English
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Biomarker-guided intervention to prevent acute kidney injury after major surgery (BigpAK-2 trial)

Joachim Gerss / Javier Ripollés-Melchor / Emmanuel Futier / Melanie Meersch / Carola Wempe / Detlef Kindgen-Milles / Alexander Zarbock / Markus W Hollmann / Sigismond Lasocki / Thomas Rimmele / Tim Rahmel / Michael Adamzik / Hartmuth Nowak / Ingeborg Welters / Brian Johnston / Ane Abad-motos / Alfredo Abad-gurumeta / Marc Moritz Berger / Davide Ricci /

Maurizio Cecconi / Gudrun Kunst / Christian Stoppe / Christian Putensen / Marlies Ostermann / Sascha Ott / Brijesh Patel / Gabriele Baldini / Antoine Lamblin / Karen Williams / Elena Mancini / Christian Arndt / Hinnerk Wulf / Marc Irqsusi / Wim Vandenberghe / John Kellum / Raphael Weiss / Jackie Donovan / Lui G Forni / Giacomo Monti / Céline Monard / Markus A Weigand / Thorsten Brenner / Ulrich Jaschinski / Carlos Lopez / Maxime Leger / Emmanuel Rineau / Philipp Simon / María Gómez-Rojo / Lars Bergmann / Alicia Waite / Savino Spadaro / Alexander Wolf / Andrew Spence / Simon Dubler / Alexander PJ Vlaar / Patrick Schober / Ben C Creagh-Brown / Nandor Marczin / Emilio Maseda / Christian Strauss / Stefano Romagnoli / Christian Nusshag / Ulrich Gobel / Ángel Candela-Toha / Jon Silversides / Nuttha Lumlertgul / Khaschayar Saadat-Gilani / Vincent Legros / Timo Brandenburger / Thomas Dimski / Laura Huthmann / Claude Pelletier / Manon Schleß / Peter Rosenberger / Helene Häberle / Jan Gerrit Haaker / Matthias Gründel / Lucia Cattin / Laura Villarino Villa / Juan Victor Lorente / Christine Martin / Jan Larmann / Wolfgang Bauer / Giovanni Borghi / Benjamin O’Brien / Thilo von Groote / Antoine Guillaume Schneider / Silvia De Rosa / Diego Parise / Alice Bernard / Paula Fernández-Valdes-Bango / Irene Romero Bhathal / A Suarez-de-la-Rica / Gianluca Villa / Raquel García-Álvarez / Antonio Siniscalchi / Richard Ellerkmann / Florian Espeter / Christian Porschen / Mahan Sadjadi / Michael Storck / Tobias Brix / Dana Meschede / Wida Amini / Carina Stenger / Julius Freytag / Jens Brands / Matthias Unterberg / Britta Marko / Fabian Dusse / Wolfgang A Wetsch / Sandra E Stoll / Hendrik Drinhaus / Bernd W Böttiger / Onnen Mörer / Lars-Olav Harnisch / Roswitha Lubjuhn / Daniel Heise / Christian Bode / Andrea Sauer / Konrad Peukert / Lennart Wild / Philippe Kruse / Jan Menzenbach / Valbona Mirakaj / Sabine Hermann / Stefanie Decker / Mona Jung-König / Tobias Hölle / Sarah Dehne / Jörg Reutershan / Thomas Prüfer / Stefan Pielmeier / Indra Wimmelmeier / Michaela Scholz / Andrea Paris / Isabel Christina Gallego Zapata / Holger Pohl / Nirmeen Fayed / Kai Dielmann / Evelyn Martin / Tilo Koch / Alexander Mück / Philipp Deetjen / Ngoc Bich Mehlmann / Peter M Spieth / Andreas Güldner / Axel Rand / Maximillian Ragaller / Martin Mirus / Rebecca Bockholt / Marc Herzog / Maren Kleine-Brüggeney / Ant Isabelle Cristiani / Marion Ohl / Monica Vieira Da Silva / Gilda Filipe de Castro Reblo / Matthias Hilty / Katharina Spanaus / Benedetta Mura / Eleonora Terreni / Francesco Magiotti / Lorenzo Turi / Cristiana Laici / Chiara Capozzi / Andrea Castelli / Massimiliano Greco / Antonio Messina / Gianluca Castellani / Romina Aceto / Vinicio Danzi / Alessandro Rigobello / Massimo De Cal / Monica Zanella / Gaetano Scaramuzzo / Riccardo La Rosa / Paolo Priani / Alberto Volta Carlo / Stefano Turi / Martina Baiardo Redaelli / Marilena Marmiere / Kittisak Weerapolchai / Shelley Lorah / Fabiola D’Amato / Aneta Bociek / Rosario Lim / Benjie Cendreda / Reynaldo Dela Cuesta / Eirini Kosifidou / Zoka Milan / Juliana Fernanda / Emma Clarey / Daveena Meeks / Nicholas J Lees / Marco Scaramuzzi / Orinta Kviatkovske / Adam Glass / Christine Turley / Charlotte Quinn / Syeda Haider / Adam Rossiter / Syed Nasser / Ned Gilbert-Kawai / Tatjana Besse-Hammer / Eric Hoste / Hannah Schaubroeck / Jan De Waele / Jenni Breel / Eline de Klerk / Harm-Jan de Grooth / Lothar Schwarte / Alexander Loer / Alicia Ruiz-Escobar / Diana Fernández-García / Nerea Gómez-Pérez / Pascual Crespo-Aliseda / Cristina Cerro-Zaballos / Cristina Fernández-Martín / Eduardo Martín-Montero / Alejandro Suarez de la Rica / Héctor Berges Gutiérrez / Maria del Pino Heredia Pérez / Maria de los Reyes Bellido Fernández / Liena Izquierdo López / Javier Valiente Lourtau / Ma Angeles Ferre Colomer / Ma Azucena Pajares Moncho / Maria Jesús Montero Hernández / Esther Pérez Sancho / Silvia Polo Matínez / Pedro Rivera Soria / Maider Puyada Jáuregui / Hugo Rivera Ramos / Marta Antelo Adrán / Ramón Adalia Bartolomé / Patricia Galán Menéndez / Laura Llinares Espin / Yuri Santiago Loaiza Aldean / Víctor MoralesAriza / Rosalía Navarro-Perez / Luis Santé-Serna / Pedro de la Calle-Elguezabal / Rubén Sánchez-Martín / Inés De Soto / Pau Vallhonrat Alcántara / Laura Perelló Cerdà / Gal·la Rouras Hurtado / Paula Rodriguez Nieto / John Narros Sicluna / Angel Molero Molinero / Juan Pablo Nocete / Elena Murcia Sánchez / Stanislas Abrard / Marie-Luce Parrouffe / Frank Bidar / Lucie Aupetitgendre / Ugo Schiff / Bertille Paquette / Gaëlle Sellier / Nathalie Borgnetta / Benjamin Brochet / Thierry Floch / Julien Coffinet / Marion Leclercq-Rouget

BMJ Open, Vol 13, Iss

study protocol for an international, prospective, randomised controlled multicentre trial

2023 Volume 3

Abstract: Introduction Previous studies demonstrated that the implementation of the Kidney Disease Improving Global Outcomes (KDIGO) guideline-based bundle, consisting of different supportive measures in patients at high risk for acute kidney injury (AKI), might ... ...

Abstract	Introduction Previous studies demonstrated that the implementation of the Kidney Disease Improving Global Outcomes (KDIGO) guideline-based bundle, consisting of different supportive measures in patients at high risk for acute kidney injury (AKI), might reduce rate and severity of AKI after surgery. However, the effects of the care bundle in broader population of patients undergoing surgery require confirmation.Methods and analysis The BigpAK-2 trial is an international, randomised, controlled, multicentre trial. The trial aims to enrol 1302 patients undergoing major surgery who are subsequently admitted to the intensive care or high dependency unit and are at high-risk for postoperative AKI as identified by urinary biomarkers (tissue inhibitor of metalloproteinases 2insulin like growth factor binding protein 7 (TIMP-2)IGFBP7)). Eligible patients will be randomised to receive either standard of care (control) or a KDIGO-based AKI care bundle (intervention). The primary endpoint is the incidence of moderate or severe AKI (stage 2 or 3) within 72 hours after surgery, according to the KDIGO 2012 criteria. Secondary endpoints include adherence to the KDIGO care bundle, occurrence and severity of any stage of AKI, change in biomarker values during 12 hours after initial measurement of (TIMP-2)*(IGFBP7), number of free days of mechanical ventilation and vasopressors, need for renal replacement therapy (RRT), duration of RRT, renal recovery, 30-day and 60-day mortality, intensive care unit length-of-stay and hospital length-of-stay and major adverse kidney events. An add-on study will investigate blood and urine samples from recruited patients for immunological functions and kidney damage.Ethics and dissemination The BigpAK-2 trial was approved by the Ethics Committee of the Medical Faculty of the University of Münster and subsequently by the corresponding Ethics Committee of the participating sites. A study amendment was approved subsequently. In the UK, the trial was adopted as an NIHR portfolio study. Results will ...
Keywords	Medicine ; R
Subject code	616 ; 610
Language	English
Publishing date	2023-03-01T00:00:00Z
Publisher	BMJ Publishing Group
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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