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15. Safety and efficacy of regional citrate anticoagulation in continuous venovenous hemodialysis in the presence of liver failure: the Liver Citrate Anticoagulation Threshold (L-CAT) observational study

Author

Slowinski, Torsten, Morgera, Stanislao, Joannidis, Michael, Henneberg, Thomas, Stocker, Reto, Helset, Elin, Andersson, Kirsti, Wehner, Markus, Kozik-Jaromin, Justyna, Brett, Sarah, Hasslacher, Julia, Stover, John F., Peters, Harm, Neumayer, Hans-H., and Kindgen-Milles, Detlef

Published
2015
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22. CytoResc – 'CytoSorb' Rescue for critically ill patients undergoing the COVID-19 Cytokine Storm: A structured summary of a study protocol for a randomized controlled trial

Author

Stockmann, Helena, Keller, Theresa, Büttner, Stefan, Jörres, Achim, Kindgen-Milles, Detlef, Kunz, Julius Valentin, Leebmann, Josef, Spies, Claudia, Träger, Karl, Treskatsch, Sascha, Uhrig, Alexander, Willam, Carsten, Enghard, Philipp, Slowinski , Torsten, and CytoResc Trial Investigators

Subjects
protocol, COVID-19, Randomized controlled trial, extracorporeal cytokine elimination, cytokine storm, vasoplegic shock, medicine.medical_specialty, Randomization, Letter, medicine.medical_treatment, Medicine (miscellaneous), law.invention, 03 medical and health sciences, 0302 clinical medicine, Medizinische Fakultät, law, Intensive care, Clinical endpoint, medicine, Pharmacology (medical), ddc:610, 030212 general & internal medicine, Renal replacement therapy, Contraindication, Mechanical ventilation, lcsh:R5-920, business.industry, Clinical trial, Emergency medicine, lcsh:Medicine (General), business, 030217 neurology & neurosurgery
Abstract

Objectives Approximately 8 - 10 % of COVID-19 patients present with a serious clinical course and need for hospitalization, 8% of hospitalized patients need ICU-treatment. Currently, no causal therapy is available and treatment is purely supportive. The main reason for death in critically ill patients is acute respiratory failure. However, in a number of patients a severe hyperinflammatory response with excessively elevated proinflammatory cytokines causes vasoplegic shock resistant to vasopressor therapy. A new polystyrene-based hemoadsorber (CytoSorb®, Cytosorbents Inc., New Jersey, USA) has been shown to adsorb effectively cytokines and other middle molecular weight toxins this way reducing their blood concentrations. This has been routinely used in clinical practice in the EU for other conditions where a cytokine storm occurs and an observational study has just been completed on COVID-19 patients. We hypothesized that the extracorporeal elimination of cytokines in critically ill COVID-19 patients with suspected hyperinflammation and shock may stabilize hemodynamics and improve outcome. The primary endpoint is time until resolution of vasoplegic shock, which is a well implemented, clinically relevant endpoint in critical care studies. Trial design Phase IIb, multicenter, prospective, open-label, randomized, 1:1 parallel group pilot study comparing the additional use of “CytoSorb” to standard of care without “CytoSorb”. Participants Patients are recruited from the Intensive Care Units (ICUs) of 7 participating centers in Germany (approximately 10 ICUs). All patients aged 18- 80 with positive polymerase chain reaction (PCR) test for SARS-CoV-2, a C-reactive protein (CRP) ≥ 100 mg/l, a Procalcitonin (PCT) < 2 ng/l, and suspected cytokine storm defined via a vasoplegic shock (Norepinephrine > 0.2 μg/min/kg to achieve a Mean Arterial Pressure ≥ 65mmHg). Patients are included irrespective of indication for renal replacement therapy. Suspected or proven bacterial cause for vasoplegic shock is a contraindication. Intervention and comparator Within 24 hours after meeting the inclusion criteria patients will be randomized to receive either standard of care or standard of care and additional “CytoSorb” therapy via a shaldon catheter for 3-7 days. Filter exchange is done every 24 hours. If patients receive antibiotics, an additional dose of antibiotics is administered after each change of “CytoSorb” filter in order to prevent underdosing due to “CytoSorb” treatment. Main outcomes Primary outcome is time to resolution of vasoplegic shock (defined as no need for vasopressors for at least 8 hours in order to sustain a MAP ≥ 65mmHg) in days. Secondary outcomes are 7 day mortality after fulfilling the inclusion criteria, mortality until hospital discharge, Interleukin-6 (IL-6) measurement on day 1 and 3, need for mechanical ventilation, duration of mechanical ventilation, duration of ICU-stay, catecholamine dose on day 1/2/3 after start of “CytoSorb” and acute kidney injury. Randomization An electronic randomization will be performed using the study software secuTrial® administered by the Clinical Study Center (CSC) of the Charité – Universitätsmedizin Berlin, Germany. Randomization is done in blocks by 4 stratified by including center. Blinding (masking) The trial will be non-blinded for the clinicians and patients. The statistician will receive a blinded data set, so that all analyses will be conducted blinded. Numbers to be randomized (sample size) As this is a pilot study with the goal to examine the feasibility of the study design as well as the intervention effect, no formal sample size calculation was conducted. A total number of approximately 80-100 patients is planned (40-50 patients per group). Safety assessment is done after the inclusion of each 10 patients per randomization group. Trial Status Please see the study protocol version from April 24 2020. Recruitment of patients is still pending. Trial registration The study was registered on April 27 2020 in the German Registry of Clinical Trials (DRKS) under the number DRKS00021447. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

Published
2020

29. Relationship between GFR, intact PTH, oxidized PTH, non‐oxidized PTH as well as FGF23 in patients with CKD

Author

Zeng, Shufei, primary, Querfeld, Uwe, additional, Feger, Martina, additional, Haffner, Dieter, additional, Hasan, Ahmed A., additional, Chu, Chang, additional, Slowinski, Torsten, additional, Bernd Dschietzig, Thomas, additional, Schäfer, Franz, additional, Xiong, Yingquan, additional, Zhang, Bingbing, additional, Rausch, Steffen, additional, Horvathova, Katarina, additional, Lang, Florian, additional, Karl Krämer, Bernhard, additional, Föller, Michael, additional, and Hocher, Berthold, additional

Published
2020
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32. Regional citrate versus systemic heparin anticoagulation for continuous renal replacement therapy in critically ill patients with acute kidney injury (RICH) trial: study protocol for a multicentre, randomised controlled trial

Author

Meersch, Melanie, Küllmar, Mira, Wempe, Carola, Kindgen-Milles, Detlef, Kluge, Stefan, Slowinski, Torsten, Marx, Gernot, Gerss, Joachim, Zarbock, Alexander, and SepNet Critical Care Trials Group

Subjects
medicine.medical_specialty, Continuous Renal Replacement Therapy, Critical Illness, medicine.medical_treatment, 030232 urology & nephrology, Renal function, Hemorrhage, Infections, acute renal failure, Citric Acid, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Protocol, Humans, Medicine, Blood Transfusion, Renal replacement therapy, anticoagulation, Intensive care medicine, Heparin, business.industry, Intensive Care, Acute kidney injury, Anticoagulants, 030208 emergency & critical care medicine, Health Care Costs, Recovery of Function, General Medicine, Acute Kidney Injury, Length of Stay, medicine.disease, Intensive care unit, Survival Rate, Clinical trial, Cytokines, Complication, business, medicine.drug
Abstract

BMJ open 9(1), e024411 (2019). doi:10.1136/bmjopen-2018-024411, Published by BMJ Publishing Group, London

Published
2019
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