October 3, 2016

PRESIDENT’S SESSION 

CLINICAL TRIALS IN INTENSIVE CARE        

#LIVES2016        

ESICM President Daniel De Backer (Braine L'Alleud, Belgium) and President-elect Massimo Antonelli (Rome, Italy) host this first daily session at LIVES 2016 focused on clinical trials in intensive care, with results from seven novel trials presented for the first time. This cutting-edge session features a number of timely and topical clinical trials, some of which will be published simultaneously in major scientific journals…

Intravenous polyspecific immunoglobulin G for patients with necrotizing soft tissue infection – results of the randomised, blinded, placebo-controlled INSTINCT trial

Necrotizing soft tissue infection (NSTI) is an aggressive bacterial infection, which results in severe morbidity. The aim of the INSTINCT trial was to test the effect of intravenous polyspecific immunoglobulin G (IVIG) compared with placebo on the patient-reported outcome measure Physical Component Summary Score (PCS) of the SF-36 in patients with NSTI.

  ~ Martin Bruun Madsen 


 “In critically ill ventilated patients; sedation level is king”

Early pain, agitation, depth of sedation and mobilisation as predictors of 180-day mortality: A multinational prospective longitudinal cohort study (The SPICE-PAD Study)   

The early optimal management of pain, sedation, agitation and delirium (PAD) is an important component in the care of ventilated critically ill patients. Genuine uncertainty surrounds the impact of these components on long-term outcome. Furthermore, while light sedation is often recommended, there no evidence based consensus on what defines light sedation.

“The newly developed Sedation Index, allows clearer identification of over-sedation which strongly predicts long-term mortality”.

In 42 ICUs, 703 patients were prospectively and longitudinally followed till 180 days. We present a clearer indication that early sedation level should be tightly controlled closer to the optimal 0 RASS rather than an arbitrary defined RASS range. We also address the link between the PAD components and time to extubation, delirium and 180-day mortality.

  ~ Yahya Shehabi    


Intravenous iron or placebo for anaemia in intensive care: The IRONMAN randomised controlled trial

The IRONMAN Study was a multicentre RCT endorsed by the ANZICS CTG, investigating the safety and efficacy of IV iron as a treatment to reduce red blood cell transfusion in patients admitted to the ICU. This is the first presentation of the full study results for a trial of interest to all clinicians that deal with the common problems of anaemia and transfusion in the ICU. 

'"We are currently stuck between the rock of a restrictive transfusion trigger, and the hard place of persistent anaemia, perhaps IV iron is the answer we have been waiting for'".  

Edward Litton

 


Nitric oxide administration during paediatric cardiopulmonary bypass: A randomised controlled trial  

In a group of 198 children having major cardiac surgery, the 101 were randomised to  have Nitric Oxide, at 20 ppm, added to the oxygenator gas flow during cardiopulmonary bypass. Approximately 1/3 were neonates, 1/3infants, and 1/3 older children and adolescents.  The frequency of Low Cardiac Output Syndrome and use of ECMO, RRT and mechanical ventilation were different between these groups. The effects were age dependant and more significant in younger patients and those with more severe lesions.

  ~ Warwick Butt   


Dexmedetomidine for ventilated septic patients in ICU: A multicentre randomised controlled trial 

Dexmedetomidine has been reported to provide better sedation for patients under ventilation; however, its effects on mortality and ventilator-free days have not been well scrutinised among sepsis patients. The aim of our study is to examine whether a sedation strategy with dexmedetomidine can improve clinical outcomes by providing organ protective effects in ventilated sepsis patients.

Kyohei Miyamoto


McGrath Mac videolaryngoscope versus Macintosh laryngoscope for orotracheal intubation in intensive care patients: The randomised multicentre MACMAN trial   

Critically ill patients often exhibit acute respiratory, haemodynamic, and neurologic failures that increase the risks associated with endotracheal intubation. Videolaryngoscopy is increasingly used for orotracheal intubation in the ICU despite lack of evidence that it improves the first-pass success rate. During the randomised controlled non-blinded multicentre superiority trial (MACMAN), 371 adults requiring intubation were randomised between McGrath MAC videolaryngoscope and conventionnal Macintosh laryngoscope. 

  ~ Jean-Baptiste Lascarrou  

 

This session will also include a cast of expert commentators, who will provide commentary following each presentation and serve as a catalyst for further discussion and thought on the results of this Clinical Trials Session. Here is a full list of presentations and expert commentators:

Intravenous polyspecific immunoglobulin G for patients with necrotizing soft tissue infection: Results of the randomised, blinded, placebo-controlled INSTINCT trial    
Speaker: Martin Bruun Madsen, Copenhagen, Denmark
Commentator: Kapil Zirpe, Pune, India

Early pain, agitation, depth of sedation and mobilisation as predictors of 180-day mortality: A multinational prospective longitudinal cohort study (The SPICE-PAD Study)    
Speaker: Yahya Shehabi, Sydney, Australia
Commentator: Enrique Fernández-Mondéjar, Granada, Spain

Intravenous iron or placebo for anaemia in intensive care: The IRONMAN randomised controlled trial    
Speaker: Edward Litton, Perth, Australia
Commentator: Mirella Cristine Oliveira, Curitiba, Brazil

Nitric oxide administration during paediatric cardiopulmonary bypass: A randomised controlled trial    
Speaker: Warwick Butt, Melbourne, Australia
Commentator: Diederik Gommers, Rotterdam, Netherlands

Hydrocortisone for Prevention of Septic Shock (HYPRESS): A randomised controlled trial    
Speaker: Didier Keh, Berlin, Germany
Commentator: Todd Dorman, Baltimore, United States

Dexmedetomidine for ventilated septic patients in ICU: A multicentre randomised controlled trial    
Speaker: Kyohei Miyamoto, Wakayama, Japan
Commentator: Jean-Paul Mira, Paris, France

McGrath Mac videolaryngoscope versus Macintosh laryngoscope for orotracheal intubation in intensive care patients: The randomised multicentre MACMAN trial    
Speaker: Jean-Baptiste Lascarrou, La Roche-sur-Yon, France
Commentator: Nishimura Masaji, Tokushima, Japan
 

Join this exciting clinical trials session LIVE…

Thematic Session ~ PRESIDENT'S SESSION: CLINICAL TRIALS IN INTENSIVE CARE  

03.10.2016, 16:00 – 18:05, room Milan 

 
#LIVES2016 #metabolic #sepsis #paed 

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