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Book ; Thesis: Main and alternative pathways of the renin-angiotensin system in autoimmune inflammation of the central nervous system

Manzel, Arndt

2013

Author's details	by Arndt Manzel
Keywords	Biowissenschaften ; Autoaggressionskrankheit ; Immunologie ; Neuroimmunologie ; Multiple Sklerose
Subject	Encephalomyelitis disseminata ; Immunoneurologie ; Klinische Immunologie ; Autoantikörperkrankheit ; Autoimmunkrankheit ; Autoimmunopathie ; Autoimmunerkrankung ; Life Sciences ; Life-Sciences ; Biowissenschaft ; Lebenswissenschaften
Language	English
Size	VII, 107 S. : Ill., graph. Darst.
Publishing place	Bochum
Publishing country	Germany
Document type	Book ; Thesis
Thesis / German Habilitation thesis	Bochum, Univ., Diss., 2013
HBZ-ID	HT017907349
Database	Catalogue ZB MED Medicine, Health

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Article ; Online: Exploring solid-phase proximity ligation assay for survivin detection in urine.

Jan Gleichenhagen / Christian Arndt / Swaantje Casjens / Carmen Töpfer / Holger Gerullis / Irina Raiko / Dirk Taeger / Thorsten Ecke / Thomas Brüning / Georg Johnen

PLoS ONE, Vol 17, Iss 6, p e

2022 Volume 0270535

Abstract: Urine-based biomarkers are a rational and promising approach for the detection of bladder cancer due to the proximity of urine to the location of the tumor site and the non-invasive nature of its sampling. A well-known and highly investigated biomarker ... ...

Abstract	Urine-based biomarkers are a rational and promising approach for the detection of bladder cancer due to the proximity of urine to the location of the tumor site and the non-invasive nature of its sampling. A well-known and highly investigated biomarker for bladder cancer is survivin. For detection of very small amounts of urinary survivin protein a highly sensitive assay was developed. The assay is based on the immuno-PCR technology, more precisely a solid-phase proximity ligation assay (spPLA). The limit of detection for the survivin spPLA was 1.45 pg/mL, resulting in an improvement of the limit of detection by a factor of approximately 23 compared to the previously in-house developed survivin ELISA. A key step in development was the initial isolation of survivin by a molecular fishing rod based on magnetic beads. Interfering matrix compounds pose a special challenge for further analytical application, but can be overcome by this isolation step. The assay is designed to work with only 500 μL of voided urine. The survivin spPLA showed a sensitivity of 30% and specificity of 89% for bladder cancer detection in this study of 110 bladder cancer cases and 133 clinical controls. Moreover, the results demonstrated again that survivin is a useful complementary marker in combination with UBC® Rapid by increasing the overall sensitivity to 70% with a specificity of 86%. Although the performance for detection of bladder cancer was rather low, the herein developed assay might serve as a new tool for survivin biomarker research in diverse human fluids, even if the biological matrix is complex or survivin is only present in small amounts.
Keywords	Medicine ; R ; Science ; Q
Subject code	500
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: Outcome after Interdisciplinary Treatment for Aneurysmal Subarachnoid Hemorrhage—A Single Center Experience

Benjamin Voellger / Rosita Rupa / Christian Arndt / Barbara Carl / Christopher Nimsky

Medicina, Vol 55, Iss 11, p

2019 Volume 724

Abstract: Background and Objective s: To identify predictors of outcome after aneurysmal subarachnoid hemorrhage (aSAH) in our interdisciplinary setting. Materials and Methods : 176 patients who had been treated for aSAH by a team of neurosurgeons and ... ...

Abstract	Background and Objective s: To identify predictors of outcome after aneurysmal subarachnoid hemorrhage (aSAH) in our interdisciplinary setting. Materials and Methods : 176 patients who had been treated for aSAH by a team of neurosurgeons and neuroradiologists between 2009 and 2017 were analyzed retrospectively. Age, gender, clinical presentation according to the Hunt and Hess (H&H) grading on admission, overall clot burden, aneurysm localization, modality of aneurysm obliteration, early deterioration (ED), occurrence of vasospasm in transcranial Doppler ultrasonography, delayed cerebral ischemia (DCI), spasmolysis, decompressive craniectomy (DC), cerebrospinal fluid (CSF) shunt placement, deep vein thrombosis (DVT), pulmonary embolism (PE), severe cardiac events (SCE), mortality on Days 14, and 30 after admission, and outcome at one year after the hemorrhage according to the Glasgow Outcome Scale (GOS) were recorded. Chi square, Fisher’s exact, Welch’s t, and Wilcoxon rank sum served as statistical tests. Generalized linear models were fitted, and ordered logistic regression was performed. Results : SCE ( p = 0.049) were a significant predictor of mortality at 14 days after aSAH, but not later during the first year after the hemorrhage. Clipping as opposed to coiling ( p = 0.049) of ruptured aneurysms was a significant predictor of survival on Day 30 after aSAH, but not later during the first year after the hemorrhage, while coiling as opposed to clipping of ruptured aneurysms was significantly related to a lower frequency of DVT during hospitalization ( p = 0.024). Aneurysms of the anterior circulation were significantly more often clipped, while aneurysms of the posterior circulation were significantly more often coiled ( p < 0.001). Age over 70 years ( p = 0.049), H&H grade on admission ( p = 0.022), overall clot burden ( p = 0.035), ED ( p = 0.009), DCI ( p = 0.013), DC ( p = 0.0005), and CSF shunt placement ( p = 0.038) proved to be predictive of long-term outcome after aSAH. Conclusion : Long-term results after clipping and coiling of ruptured aneurysms appear equal in an interdisciplinary setting that takes aneurysm localization, available staff, and equipment into account.
Keywords	aneurysmal subarachnoid hemorrhage ; outcome ; interdisciplinary setting ; Medicine (General) ; R5-920
Subject code	610
Language	English
Publishing date	2019-11-01T00:00:00Z
Publisher	MDPI AG
Document type	Article ; Online
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Article ; Online: Evaluation of a New Survivin ELISA and UBC® Rapid for the Detection of Bladder Cancer in Urine

Jan Gleichenhagen / Christian Arndt / Swaantje Casjens / Carmen Meinig / Holger Gerullis / Irina Raiko / Thomas Brüning / Thorsten Ecke / Georg Johnen

International Journal of Molecular Sciences, Vol 19, Iss 1, p

2018 Volume 226

Abstract: Urine-based biomarkers for non-invasive diagnosis of bladder cancer are urgently needed. No single marker with sufficient sensitivity and specificity has been described so far. Thus, a combination of markers appears to be a promising approach. The aim of ...

Abstract	Urine-based biomarkers for non-invasive diagnosis of bladder cancer are urgently needed. No single marker with sufficient sensitivity and specificity has been described so far. Thus, a combination of markers appears to be a promising approach. The aim of this case-control study was to evaluate the performance of an in-house developed enzyme-linked immunosorbent assay (ELISA) for survivin, the UBC® Rapid test, and the combination of both assays. A total of 290 patients were recruited. Due to prior bladder cancer, 46 patients were excluded. Urine samples were available from 111 patients with bladder cancer and 133 clinical controls without urologic diseases. Antibodies generated from recombinant survivin were utilized to develop a sandwich ELISA. The ELISA and the UBC® Rapid test were applied to all urine samples. Receiver operating characteristic (ROC) analysis was used to evaluate marker performance. The survivin ELISA exhibited a sensitivity of 35% with a specificity of 98%. The UBC® Rapid test showed a sensitivity of 56% and a specificity of 96%. Combination of both assays increased the sensitivity to 66% with a specificity of 95%. For high-grade tumors, the combination showed a sensitivity of 82% and a specificity of 95%. The new survivin ELISA and the UBC® Rapid test are both able to detect bladder cancer, especially high-grade tumors. However, the performance of each individual marker is moderate and efforts to improve the survivin assay should be pursued. A combination of both assays confirmed the benefit of using marker panels. The results need further testing in a prospective study and with a high-risk population.
Keywords	survivin ; UBC® Rapid ; bladder cancer ; urine ; biomarker combination ; non-invasive ; Biology (General) ; QH301-705.5 ; Chemistry ; QD1-999
Subject code	610
Language	English
Publishing date	2018-01-01T00:00:00Z
Publisher	MDPI AG
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: UBC ® Rapid Test—A Urinary Point-of-Care (POC) Assay for Diagnosis of Bladder Cancer with a focus on Non-Muscle Invasive High-Grade Tumors

Thorsten H. Ecke / Sarah Weiß / Carsten Stephan / Steffen Hallmann / Christian Arndt / Dimitri Barski / Thomas Otto / Holger Gerullis

International Journal of Molecular Sciences, Vol 19, Iss 12, p

Results of a Multicenter-Study

2018 Volume 3841

Abstract: Objectives: UBC ® Rapid Test measures soluble fragments of cytokeratins 8 and 18 in urine. We present results of a multicenter study using an updated version of UBC ® Rapid Test in bladder cancer patients, patients with urinary bladder cancer positive ... ...

Abstract	Objectives: UBC ® Rapid Test measures soluble fragments of cytokeratins 8 and 18 in urine. We present results of a multicenter study using an updated version of UBC ® Rapid Test in bladder cancer patients, patients with urinary bladder cancer positive history, and healthy controls. Material and Methods: In total 530 urine samples have been included in this study. Clinical urine samples were used from 242 patients with tumors of the urinary bladder (134 non-muscle-invasive low-grade tumors (NMI-LG), 48 non-muscle-invasive high-grade tumors (NMI-HG), and 60 muscle-invasive high-grade tumors (MI-HG)), 62 patients with non-evidence of disease (NED), and 226 healthy controls. Urine samples were analyzed by the UBC ® Rapid point-of-care (POC) assay and evaluated by Concile Omega 100 POC Reader. All statistical analyses have been performed using R version 3.2.3. Results: Elevated levels of UBC ® Rapid Test in urine are higher in patients with bladder cancer in comparison to the control group ( p < 0.001). The sensitivity for the whole bladder cancer cohort was 53.3% (positive predictive value (PPV) 90.2%, negative predictive value (NPV) 65.2%) and was 38.8% (PPV 78.8%, NPV 72.1%) for non-muscle-invasive low-grade bladder cancer; 75.0% (PPV 72.0%, NPV 94.7%) for non-muscle-invasive high-grade bladder cancer and 68.3% (PPV 74.6%, NPV 91.8%) for muscle-invasive high-grade bladder cancer. The specificity for the statistical calculations was 93.8%. The cut-off value (10 µg/L) was evaluated for the whole patient cohort. The area under the curve of the quantitative UBC ® Rapid Test using the optimal threshold obtained by receiver operating characteristics (ROC) analysis was 0.774. Elevated values of UBC ® Rapid Test in urine are higher in patients with high-grade bladder cancer in comparison to low-grade tumors and the healthy control group. Conclusions: UBC ® Rapid Test has potential to be a clinically valuable urinary protein biomarker for detection of high-grade bladder cancer patients and could be added in the ...
Keywords	bladder cancer ; tumor markers ; urinary based diagnostics ; Biology (General) ; QH301-705.5 ; Chemistry ; QD1-999
Language	English
Publishing date	2018-12-01T00:00:00Z
Publisher	MDPI AG
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Influence of quality of intensive care on quality of life/return to work in survivors of the acute respiratory distress syndrome

Christian Apfelbacher / Susanne Brandstetter / Sebastian Blecha / Frank Dodoo-Schittko / Magdalena Brandl / Christian Karagiannidis / Michael Quintel / Stefan Kluge / Christian Putensen / Sven Bercker / Björn Ellger / Thomas Kirschning / Christian Arndt / Patrick Meybohm / Steffen Weber-Carstens / the DACAPO study group / Thomas Bein

BMC Public Health, Vol 20, Iss 1, Pp 1-

prospective observational patient cohort study (DACAPO)

2020 Volume 9

Abstract: Abstract Background Significant long-term reduction in health-related quality of life (HRQoL) is often observed in survivors of the acute respiratory distress syndrome (ARDS), and return to work (RtW) is limited. There is a paucity of data regarding the ... ...

Abstract	Abstract Background Significant long-term reduction in health-related quality of life (HRQoL) is often observed in survivors of the acute respiratory distress syndrome (ARDS), and return to work (RtW) is limited. There is a paucity of data regarding the relationship between the quality of care (QoC) in the intensive care unit (ICU) and both HRQoL and RtW in ARDS survivors. Therefore, the aim of our study was to investigate associations between indicators of QoC and HRQoL and RtW in a cohort of survivors of ARDS. Methods To determine the influence of QoC on HRQoL and RtW 1 year after ICU-discharge, ARDS patients were recruited into a prospective multi-centre patient cohort study and followed up regularly after discharge. Patients were asked to complete self-report questionnaires on HRQoL (Short Form 12 physical component scale (PCS) and mental component scale (MCS)) and RtW. Indicators of QoC pertaining to volume, structural and process quality, and general characteristics were recorded on ICU level. Associations between QoC indicators and HrQoL and RtW were investigated by multivariable linear and Cox regression modelling, respectively. B values and hazard ratios (HRs) are reported with corresponding 95% confidence intervals (CIs). Results 877 (of initially 1225 enrolled) people with ARDS formed the DACAPO survivor cohort, 396 were finally followed up to 1 year after discharge. The twelve-month survivors were characterized by a reduced HRQoL with a greater impairment in the physical component (Md 41.2 IQR [34–52]) compared to the mental component (Md 47.3 IQR [33–57]). Overall, 50% of the patients returned to work. The proportion of ventilated ICU patients showed significant negative associations with both 12 months PCS (B = − 11.22, CI −20.71; − 1,74) and RtW (HR = 0,18, CI 0,04;0,80). All other QoC indicators were not significantly related to outcome. Conclusions Associations between ICU QoC and long-term HrQoL and RtW were weak and largely non-significant. Residual confounding by case mix, treatment variables ...
Keywords	ARDS ; Quality of care ; Volume ; ICU ; Health-related quality of life ; Return to work ; Public aspects of medicine ; RA1-1270
Subject code	360
Language	English
Publishing date	2020-06-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Book ; Online ; Thesis: Mitochondriale Zytopathien

Haverkamp, Lars Christian Arndt Simon [Verfasser]

Aufarbeitung der unterschiedlichen Pathogenese ausgewählter mitochondrialer Zytopathien anhand von zwei Fallbeispielen

2008

Author's details	vorgelegt von Lars Christian Arndt Simon Haverkamp
Keywords	Medizin, Gesundheit ; Medicine, Health
Subject code	sg610
Language	German
Document type	Book ; Online ; Thesis
Database	Digital theses on the web

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Article ; Online: Coating with Autologous Plasma Improves Biocompatibility of Mesh Grafts In Vitro

Holger Gerullis / Evangelos Georgas / Christoph Eimer / Christian Arndt / Dimitri Barski / Bernhard Lammers / Bernd Klosterhalfen / Mihaly Borós / Thomas Otto

BioMed Research International, Vol

Development Stage of a Surgical Innovation

2013 Volume 2013

Abstract: Purpose. To investigate mesh coating modalities with autologous blood components in a recently developed in vitro test system for biocompatibility assessment of alloplastic materials. Materials and Methods. Seven different mesh types, currently used in ... ...

Abstract	Purpose. To investigate mesh coating modalities with autologous blood components in a recently developed in vitro test system for biocompatibility assessment of alloplastic materials. Materials and Methods. Seven different mesh types, currently used in various indications, were randomly investigated. Meshes were coated prior to cultivation with autologous peripheral blood mononuclear cells (PBMCs), platelets, and blood plasma. Pretreated meshes were incubated over 6 weeks in a minced tissue assay, representative for fibroblasts, muscle cells, and endothelial cells originating from 10 different patients. Adherence of those tissues on the meshes was microscopically investigated and semiquantitatively assessed using a previously described scoring system. Results. Coating with peripheral blood mononuclear cells did not affect the adherence score, whereas coating with platelets and blood plasma increased the score suggesting improved biocompatibility in vitro. The previous ranking of native meshes remained consistent after coating. Conclusion. Plasma coating of meshes improves their biocompatibility score in a novel in vitro test system.
Keywords	Medicine (General) ; R5-920 ; Medicine ; R
Language	English
Publishing date	2013-01-01T00:00:00Z
Publisher	Hindawi Publishing Corporation
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Inflammatory Reaction as Determinant of Foreign Body Reaction Is an Early and Susceptible Event after Mesh Implantation

Holger Gerullis / Evangelos Georgas / Mihaly Borós / Bernd Klosterhalfen / Christoph Eimer / Christian Arndt / Stephan Otto / Dimitri Barski / Dirk Ysebaert / Albert Ramon / Thomas Otto

BioMed Research International, Vol

2014 Volume 2014

Abstract: Purpose. To investigate and relate the ultrashort-term and long-term courses of determinants for foreign body reaction as biocompatibility predictors for meshes in an animal model. Materials and Methods. Three different meshes (TVT, UltraPro, and PVDF) ... ...

Abstract	Purpose. To investigate and relate the ultrashort-term and long-term courses of determinants for foreign body reaction as biocompatibility predictors for meshes in an animal model. Materials and Methods. Three different meshes (TVT, UltraPro, and PVDF) were implanted in sheep. Native and plasma coated meshes were placed bilaterally: (a) interaperitoneally, (b) as fascia onlay, and (c) as muscle onlay (fascia sublay). At 5 min, 20 min, 60 min, and 120 min meshes were explanted and histochemically investigated for inflammatory infiltrate, macrophage infiltration, vessel formation, myofibroblast invasion, and connective tissue accumulation. The results were related to long-term values over 24 months. Results. Macrophage invasion reached highest extents with up to 60% in short-term and decreased within 24 months to about 30%. Inflammatory infiltrate increased within the first 2 hours, the reached levels and the different extents and ranking among the investigated meshes remained stable during long-term follow up. For myofibroblasts, connective tissue, and CD31+ cells, no activity was detected during the first 120 min. Conclusion. The local inflammatory reaction is an early and susceptible event after mesh implantation. It cannot be influenced by prior plasma coating and does not depend on the localisation of implantation.
Keywords	Medicine ; R
Subject code	630
Language	English
Publishing date	2014-01-01T00:00:00Z
Publisher	Hindawi Limited
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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