Presenting the results of seven cutting-edge clinical trials
This session featuring results from some of the newest clinical trials – all published in Intensive Care Medicine- is led by ICM Editor-in-Chief, G. Citerio (Monza, Italy) and A. Girbes (Amsterdam, Netherlands). Of course, this ground-breaking session is not just about presentation of clinical trial results… each presentation has an appointed commentator to discuss strengths and limitations of the trial and a discussion period, so delegates can ask questions as well!
- Immune checkpoint inhibition in sepsis: a Phase 1b randomized study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of nivolumab – by M. Shankar-Hari (London, United Kingdom) – Watch the presentation on E-LIVES
- Effect of Open-Lung vs Conventional Perioperative Ventilation Strategies on Postoperative Pulmonary Complications after On-Pump Cardiac Surgery: The PROVECS Randomized Clinical Trial – by D. Lagier (Marseille, France) – Watch the presentation on E-LIVES
- Randomised Evaluation of Active Control of Temperature vs. Ordinary Temperature Management (REACTOR) Trial – by F. van Haren (Canberra, Australia) – Watch the presentation on E-LIVES
- Effects of levosimendan on respiratory muscle function in patients weaning from mechanical ventilation – by L. Roesthuis (Nijmegen, Netherlands) – Watch the presentation on E-LIVES
- Hyperoxia during cardiopulmonary bypass does not decrease cardiovascular complications following cardiac surgery: the CARDIOX randomized clinical trial – by O. Abou Arab – Watch the presentation on E-LIVES
- 154 compared to 54 mmol per liter of sodium in intravenous maintenance fluid therapy for adult patients undergoing major thoracic surgery (TOPMAST): a single center randomized controlled double-blind trial – by N. Van Regenmortel (Antwerp, Belgium) – Watch the presentation on E-LIVES
|Immune checkpoint inhibition in sepsis: a Phase 1b randomized study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of nivolumab – by M. Shankar-Hari (London, United Kingdom)
A key feature of sepsis-related immunosuppression is T cell exhaustion, which results in impaired function of T cells. Exhausted T cells often have increased expression of inhibitory check-point molecules, such as programmed cell death protein-1 (PD-1).
Hotchkiss and colleagues report one of the first clinical safety and pharmacokinetics assessments of the anti-PD-1 antibody (Nivolumab) and its effect on immune biomarkers in sepsis patients with severe lymphopenia, in a Phase1b trial.
The authors conclude that Nivolumab can be administered safely in sepsis patients and, at the doses we tested, Nivolumab had adequate pharmacokinetic/pharmacodynamic profile to inform future trials.
Dr Shankar-Hari undertook a period of clinical training in Guy’s and St Thomas’ Hospital NHS Trust, University College London Hospital NHS Trust, The Royal Free Hospital, St Mary’s Hospital and at a number of regional district general hospitals around London. He completed his MSc in Epidemiology at the London School of Hygiene and Tropical Medicine and was awarded a PhD in Immunology, for his research into in B-lymphocyte and immunoglobulins biology in sepsis, at King’s College London.
Manu was appointed as a tenured consultant physician in Intensive Care Medicine at Guy’s and St Thomas’ Hospital NHS Foundation Trust in 2009 and received the prestigious NIHR Clinician Scientist Award in 2016.
Manu was recognised for his contributions to sepsis research with the ANZICS Intensive Care Global rising star award in 2017 and International Sepsis Forum Lowry Fink Fellowship in 2019. He currently leads a translational research group, located within the School of Immunology and Microbial Sciences. The group is funded primarily by grants from the NIHR and the MRC-EME programme.
His research interests include ways to improve outcomes in adult critically ill patients with sepsis and with ARDS, by linking the illness immunobiology to interventional trial design.
|Effect of Open-Lung vs Conventional Perioperative Ventilation Strategies on Postoperative Pulmonary Complications after On-Pump Cardiac Surgery: The PROVECS Randomized Clinical Trial – by D. Lagier (Marseille, France)
PROVECS is a pragmatic, multicenter, randomized controlled trial that assessed whether a perioperative open-lung ventilation strategy, combining recruitment maneuvers, higher PEEP levels and ventilation during cardiopulmonary bypass, protects against postoperative pulmonary complications after elective on-pump cardiac surgery.
Dr Lagier is an attending physician in cardio-vascular anesthesia and intensive care at the University Hospital La Timone in Marseille (France). He is a third-year PhD student at the Aix-Marseille University. His PhD is about the biological, morphological and clinical impact of maintaining lung ventilation during cardiopulmonary bypass in cardiac surgery patients. David is also the Principal Investigator of the PROVECS randomized controlled trial.
|Effects of levosimendan on respiratory muscle function in patients weaning from mechanical ventilation – by L. Roesthuis (Nijmegen, Netherlands)
Critical illness associated diaphragm weakness frequently develops in ICU patients and is associated with adverse outcome including prolonged weaning from mechanical ventilation. Today, no drug is approved to improve respiratory muscle function. Previously we have demonstrated that the calcium sensitizer levosimendan improves contractile efficiency of the diaphragm in healthy subjects.
This randomized placebo-controlled trial aimed to investigate the effects of levosimendan on diaphragm function in patients weaning from mechanical ventilation. We found that levosimendan improves tidal volume, minute ventilation and lowers arterial CO2 in patients weaning from mechanical ventilation.
Dr Roesthuis is a Technical Physician working at the department of Intensive Care Medicine at the Radboud University Medical Center Nijmegen, the Netherlands. She obtained her Master of Science in Technical Medicine with a specialisation in Medical Signalling at the University of Twente in the Netherlands in 2013. As a Technical Physician she has specialised in monitoring techniques in complex mechanical ventilation. Currently, she combines patient care and research.
|Hyperoxia during cardiopulmonary bypass does not decrease cardiovascular complications following cardiac surgery: the CARDIOX randomized clinical trial – by O. Abou Arab
The CARDIOX Trial addressed the question: Does Hyperoxia decrease cardiovascular adverse outcomes after cardiac surgery?
The CARDIOX Trial is an open label, two-centred randomized trial and compared two targets of oxygen (150 mmHg and oxygen fraction at 1 of 1) during cardiopulmonary bypass.
The occurrence of arrhythmias and/or cardiovascular events was similar within the 15 days after surgery.
Dr Osama Abou- Arab is an anesthetist and intensivist in the cardiac surgery service of Amiens University Hospital, France. His PhD was on the theme of endothelial injury following TAVR. His clinical research interests include cardiac surgery, haemodynamics and microcirculation.
#LIVES2019 #ICU #CRITICALCARE