Clinical Trials in Intensive Care (Monday)


Intravenous polyspecific immunoglobulin G for patients with necrotizing soft tissue infection: Results of the randomised, blinded, placebo-controlled INSTINCT trial – presentation by Martin Bruun Madsen, Copenhagen, Denmark

This trial looked at all comers with necrotising soft tissue infections and was a blinded RCT using IV IG versus placebo.  They found no difference. Does this mean we should stop giving what is an expensive treatment with no benefit to people with necrotising fascitis? Not sure yet…

Read the paper when you can…


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

Interesting observational study that shows that these things do predict mortality.  But this is an association – is more work needed progress this?  It uses the “sedation index”  taking the mean of the sedation part of the RASS scores for a day.


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

This trial IS available to read here.  Also its PI Ed Litton is on twitter and seems very amenable to interaction! Overall It didn’t show a benefit of infusing Iron.  Enteral iron doesn’t work in ICU pts as hepcidin (the “master regulator”) is generally raised as an acute inflammatory marker and prevents absorption, but previous reports of reaction to Iron infusions have put people off using it – IRONMAN showed it is safe in ICU patients.  But its not an effective way to reduce transfusion, although it may have suffered from being underpowered.

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

Speaker: Warwick Butt, Melbourne, Australia


This trial (also published in ICM) looked giving Nitric Oxide to children on bypass – previous data has been encouraging. The rationale is that bypass causes SIRS (from contact activation, ischaemia reperfusion, direct myocardial injury & transfusion) and that NO may help prevent this  – it decreases infarct size in ischaemia reperfusion in rats for example, and recent adult trials have been positive.

The trial found a significant difference and low cardiac output syndrome was halved in group given nitric oxide


Hydrocortisone for Prevention of Septic Shock (HYPRESS): A randomised controlled trial

Headline from this trial was that Steroids don’t prevent septic shock.  The trial was contemporaneously published in JAMA.

Some good comments after the presentation from Todd Dorman (SCCM president) – The study was probably underpowered (as septic shock was only present in 20% of patients), the finding that in the group who received steroids there was less delirium is “interesting” and recruitment was prolonged – 5 years a long time in ICM and background care probably changed a fair amount over that time.



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

Speaker: Kyohei Miyamoto, Wakayama, Japan

Interesting study that tried to test the idea that dexmetotomidine is immunonodulatory and therefore useful in sepsis (as a sedation agent).  It made no difference to the outcome (ventilator free days or mortality) but:


A fair comment was made that as an open label trial, it carried a high risk of bias which makes the “quality of sedation”  finding more difficult to interpret.

Last but not least…


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

This neat trial from Jean-Baptiste Lascarrou (available on twitter) looked at a video laryngoscope called McGrath and tried to see if it could increase first pass intubation rates from 65% to 80% compared with direct laryngoscopy with a macintosh blade. In the end it didn’t and both groups had a 70% first pass rate.  The interesting thing was, as you might expect if you regularly use these devices, that the reason for failure was different – In some ways it is a compromise between getting a good view (harder with mac) and getting the tube in (harder with a video laryngoscope in this case McGrath)