Clinical Trials in Intensive Care (Tuesday)

TRISS follow up

Long-term outcomes in patients with septic shock transfused at a lower versus a higher haemoglobin threshold: The TRISS randomised, multicentre, clinical trial presented by Sofie Louise Rygaard, Copenhagen, Denmark (Great – she has joined twitter! )

Great stuff from the TRISS trial – which has already told us that a lower haemoglobin target is safe in septic shock and anaemia.  In this follow up long term outcomes of mortality and health related quality of life at 1 year where not significantly different in the intervention group.

As Professor Angus commented after the presentation – this critical care trial that planned long term follow up from the beginning and has now done long term follow up is to be applauded.  It seems safe to continue with a restrictive transfusion policy.

Expecting transfusion to affect mortality 2 years later may have been a bit of a stretch:

… but I think the trial is important. The paper was published in ICM – available here

GRAVITY VAP

Lateral-trendelenburg position to avoid ventilator-associated pneumonia presented by Gianluigi Li Bassi, Barcelona, Spain.

Ive been waiting for this trial for a while because it is interesting – it was challenging a dogma – (putting the bed/patient head up reduces pneumonia) for which the evidence is pretty weak, but has made it into many bundles and guidelines.

It didn’t really work sadly, the study was stopped after 400 patients as there were several adverse events in the group put head down (lateral) and there was too a low an incidence of VAP:

I don’t think its published yet.  The trial used Facebook and Twitter to help communicate as many now do.

CLASSIC trial

Restricting volumes of resuscitation fluid in patients with septic shock: The CLASSIC randomised, parallel-group, multicentre feasibility trial presented by Peter Buhl Hjortrup, Copenhagen, Denmark (twitter)

Available to read now in Intensive Care Medicine, this trial set itself up for a win, by setting its primary endpoint as actually achieving the intervention.  Not to be flippant this is harder than it seems, and they did manage it.  A feasibility trial, they have plans for a large scale trial.

The bottom line crew are all over this of course… Thanks Segun for this review.

OPERA
Effect of postoperative high-flow nasal cannula vs conventional oxygen therapy on hypoxemia in patients after major abdominal surgery: A randomised clinical trial presented by Samir Jaber, Montpellier, France

Headline: extubating onto optiflow doesn’t change hypoxaemia and stopping optiflow doesn’t cause rebound hypoxaemia. In this study. Read the paper in JAMA.

RAPIT

Improving quality of life and psychological recovery in post intensive care patients: A pragmatic multicentre randomised controlled trial, the RAPIT study presented by Janet Froulund Jensen, Hillerød, Denmark

Trial can be read in full here.  The intervention was a programme of ICU photographs and 3 follow ups over a year post ICU discharge. It might have caused less anxiety, but overall made no impact on their primary or secondary outcomes.

Also presented where:

The association between tracheal intubation during paediatric in-hospital cardiac arrest and survival
presented by Lars W. Andersen, Aarhus, Denmar

No difference in ROSC or neurological outcome found. Read the paper in JAMA.

and

Neurally Adjusted Ventilatory Assist as an alternative to Pressure Support Ventilation – A multicentre randomised trial presented by Alexandre Demoule, Paris, France

Patients felt less breathless with NAVA, but otherwise study summed up well in this tweet:

Antimicrobial resistance – a global challenge

This was a great session looking at the emerging and now obvious problem of antibiotic resistance.  Melvyn Mer opened with an overview of the problem:

Health professionals are afraid NOT to prescribe antibiotics and this is a major (but not the only) factor driving resistance across the world.  Despite international and national initiatives (such as the Anti Microbial Resistance review from the UK prime minister https://amr-review.org ) the problem is growing…

The organisms that are involved have changed over the last few years, with the pattern moving from gram positives to gram negatives – that being said MRSA and VRE are still a problem.  However the emergence of extended-spectrum Beta-lactamases (ESBLs) in Klebsiella, E Coli and Proteus along with beta-lactamase resistance among Enterobacters and Citrobacters, AND multi drug resistance in Pseudomonas aeruginosa, Acinetobacter spp., and Stenotrophomonas maltophilia becoming more common sets a scene where we ALL have a responsibility to think about antibiotics.  ICU of course tends to gather a lot of these together – the EPIC studies tell us that half the pts on ICU are infected at any one time.

This (open access) paper from the Annals of Intensive Care is worth a read to get a good overview.

Another takeaway from Melvyn Mers talk (apart from his inspirational quotes and singing!) was the spread of resistant fungals around the world.  An azole resistant candida, previously confined to the southern hemisphere, has now been isolated in the UK and an ICU somewhere in England has been fighting an outbreak of it over the last year (This alert from Public Health England from July this year is worth a read as are their guidelines on treating it).

How can we do anything about this? Well there a number of things.  Mer thought we (as a speciality) need to have clear guidelines to support health professionals NOT giving antibiotics, that there needs to be a push to address the agricultural sector (60% of worldwide antibiotics are used in animals) and, perhaps most relevant, was his plea to “get your own house in order”.  Start small…

There followed a talk from Matteo Bassetti showing the link between MDR infection with mortality – and unsurprisingly perhaps, there is a link.

Also the DALI study was mentioned – a really important ESICM study from Jason Roberts et al which not only said that ICU patients more often than not have inappropriate dosing regimens and antibiotic levels, but linked that with a poor outcome.  Worth a look: open access PDF of DALI trial

One of the solutions may well be tailoring / personalising antibiotics to the individual, including combination therapy, e.g.:

Otherwise, Dr Bassettis summary was this:

Finally in this session we heard about an initially French but now global initiative to help combat antibiotic resistance the – the world alliance against antimicrobial resistance (you can read about it here).  Overall it is one important part of the fightback that aims to bring in professionals from across the animal and human medicine spectrum and take action on antibiotic resistance.

Respiratory Monitoring to Guide Treatment

…or “You don’t know what you don’t know”

A bit of a personal piece for me. And I think the title says it all. Unless you have all of the information, then it’s hard to have all of the answers. And this is very true for ventilation. We all know that ventilation can cause as much harm as it tries to cause good in some patients, but also in some parts of some patients. But who are those patients, and are we causing a little bit of harm in all of them (that could be avoided)?

Oesophageal Pressure Monitoring

Laurent Brochard makes a compelling case for measuring this.

9780007505142And after a short talk I get it. We make many assumptions about what’s going on at the pleural and alveolar level when we drive ventilation. But we don’t really know and now perhaps we can. And when you look at the respiratory mechanics you of course see that, like all science, and to use the words of Ben Goldacre, “I Think You’ll Find It’s a Bit More Complicated Than That”.

It seems that true ventilator-patient interaction might be more accessible when you measure oesophageal pressure, and potentially the opportunity for true tailored or individualised patient therapy, a recurring theme at this year’s ESICM.

Oesophageal pressure monitoring might be the ‘missing measurement’. And it’s not just for ARDS either. In his review, and in the interview I had the pleasure of having with him this morning, Brochard explains that during the spontaneous phase of breathing on the ventilator (weaning) there might be more information to had by measuring the oesophageal pressure.

Good information, good decisions

This all needs to be integrated into patient care, and added to the clinical picture, just as an ultrasonographer like me, who also uses a stethoscope, I won’t be hanging up the latter just yet, or making decisions about my patients just because of something I am shown on a screen.

The future of oesophageal pressure monitoring is interesting, and the ESICM’s PLUG Section are working towards refining this new old technology and hopefully giving us the thing that quickly prizes money from people’s hands, some outcome improvements.

LIVES2016: SINGER vs JEAN LOUIS VINCENT debate

The second day of the conference started in the NEXT lounge with a feisty debate between Mervyn Singer and Jean-Louis Vincent – entitled “Rewriting the rules time and time again – Why syndromes are not diseases” but quickly unravelled to a lively debate with the audience asking these giants of ICU what on earth they should do know treatments are debunked and definitions changing and guidelines expanding.  Lots of fun and a positive vibe in the end – I think the summary is as #merv says, do what makes sense!

I can’t seem to get Mervyn Singer on “the twitter” but I’ve given him the hashtag #merv! – Chris Nickson had some ideas…