Category Archives: Clinical Trials

EGDT the end of an era?

Clinical Trials, LIVES 2016 - MILAN, sepsis

This was a very well attended session that began with Richard Beale taking the room through the history of EGDT – Stephen Cains dog studies showed the link between oxygen delivery and consumption, then Schumaker and Shoemaker (there is a difference!) took the concept into humans and then we had Rivers now famous study.  What i found interesting was the paper by in JAMA (http://ja.ma/2dm4K0e) from surgical patients in the early 90s which really re-ignited the idea of goals and targets, albeit in the more controlled post-op surgical insult population, but this was a key driver for Mani Rivers protocol in his study.

Then Derek Angus gave his presentation which is also going to be available (along with my interview with him afterwards) on the ESICM website to watch.

Then Andrew Rhodes talked about the future and gave some common sense advice on how to treat sepsis.  The room was full – so as JLV said today, that means we still have a problem in how to treat sepsis! Will top the bill at conferences for some time to come yet…

 

ICM year in review: respiratory, cardiodynamics and renal

Circulation, Clinical Trials, Echocardiography, LIVES 2016 - MILAN, Renal, Respiratory, Ultrasound, Year in Review

This first session of the day in room Lisbon was a rapid run through of the journals’ most important papers of the last year  – a bumper year as the journals impact factor has soared.

Some notes below:

Respiratory papers

IC-GLOSSARI, the Intensive Care Global Study on Severe Acute Respiratory Infection which was a great ESICM project led by Yasser Sakr and is described as “a multicenter, multinational, 14-day inception cohort study”, in which I admit a COI in that i was involved on one of the sites, but a good paper in that it crossed continents and showed that admission to the ICU for severe lung infection is not only common but also associated with high morbidity and mortality rates.

http://link.springer.com/article/10.1007%2Fs00134-015-4206-2

ECMO epidemiology, this German study showed an increase in ECMO use especially amongst more elderly patients, since 2007.  VV ECMO seems to have reached a “plateau” in use. Mortality has decreased over time – the authors attribute this to experience – but is still stunningly high –  58 and 66 % for vv-ECMO and va-ECMO respectively.

http://link.springer.com/article/10.1007%2Fs00134-016-4273-z

ARDS rehabilitation – Pfoh and colleagues examined “physical declines occurring after hospital discharge” in people who survive ARDS and followed up patients for 5 years.  The headline is that most people decline, and older people and those with co-morbidities decline more.

http://link.springer.com/article/10.1007%2Fs00134-016-4530-1

Lung US training – This paper followed 11 respiratory therapists who had never used ultrasound before over 9 months and claims that 12 scans is the magic number to attain competence.  The jury is out…

http://link.springer.com/article/10.1007%2Fs00134-015-4102-9

The TRACHUS trial looked at ultrasound for tracheostomy – a good idea surely.  Anyway the paper says that it is safe and useful.  As @PhilMcglone said in his review for The Bottom Line – Why choose between bronchoscopy and ultrasound when we can use both?

http://link.springer.com/article/10.1007%2Fs00134-016-4218-6

Finally in the respiratory section this directions-type paper from Jeremy Beitler and the ARDSnet group (now ARDSne(x)t – see what they did there…) on personalising ARDS treatment. The research agenda is going to ask simultaneously both “whether a treatment affords clinically meaningful benefit and for whom.” Watch this space. Or read the paper:

http://link.springer.com/article/10.1007%2Fs00134-016-4331-6

Cardiodynamics and Ultrasound

Antoine Vieillard-Baron discussed the most important papers from this excitingly titled topic.

The FENICE trial was another landmark “global inception cohort study” and looked at fluid management and fluid boluses ( et al).  It showed massive variation in what a fluid bolus is and how it is used.  The question posed by AVL was why did only 2% of physicians use echo to manage fluid? Not enough trainers? Too difficult? Maurizio himself weighed in on the twitter chat below:

Then a study from 3 countries on point of care ultrasound use was presented.  Adrian has reviewed it nicely here for the NEXT journal club – or read the paper.  POCUS is underused generally, and only half the CVC insertions were performed under US guidance.

http://link.springer.com/article/10.1007%2Fs00134-015-3952-5

Finally a nice review article (authored by the presenter) on how to use ultrasound in ventilation management – 4 key areas:

  1. Assessment of cardiac function
  2. Assessment of diaphragmatic function
  3. Assessment of lung function
  4. Identification of pleural effusion

http://link.springer.com/article/10.1007%2Fs00134-016-4245-3

Kidneys

Matt wrote a nice blog on this yesterday, so briefly some of the papers discussed today were:

Statins in heart valve surgery

http://link.springer.com/article/10.1007%2Fs00134-016-4358-8

The kidney injury epidemiology study (AKI-EPI)

http://link.springer.com/article/10.1007%2Fs00134-015-3934-7

And the Truche study – looking again at continuous vs intermittent RRT:

http://link.springer.com/article/10.1007%2Fs00134-016-4404-6

CLEAN

Clinical Trials, Infection, LIVES 2015 - BERLIN

Basic Bundle

  • Hand hygeine
  • Surgical asepsis insertion conditions
  • Avoid aqueous iodine
  • Subclavian and radial preferred
  • Remove useless catheters
  • Immediate change of soiled dressings

What about alcohol-iodine versus chlorhexidine-alcohol? Scrubbing or no-scrubbing of line areas?

2×2 factorial design

Muticentre RCT, primary outcome CRBSI

2349 enrolled with 5159 catheters!

Patients generally matched, mainly medical patients with 70% mechanically ventilated

Most patients had radial catheters (68%)

Chlorhexidine was significantly better than alcohol-PVI in reducing CRBSI. Addition of scrubbing of area added no real benefit. Chlorhexidine group had more skin reactions but they were slight.

Conclusion: 2% chlorhexidine is superior to iodine in reducing the risk of CRBSI

Skin antisepsis with chlorhexidine–alcohol versus povidone iodine–alcohol, with and without skin scrubbing, for prevention of intravascular-catheter-related infection (CLEAN): an open-label, multicentre, randomised, controlled, two-by-two factorial trial

EuroTHERM3235

Clinical Trials, LIVES 2015 - BERLIN, Neurology

A number of injuries can produce a GCS 3 and interventions are multiple with varying evidence of efficacy

Pragmatic, multicentre multinational RCT

Open-label with blinded follow-up

Could be randomised up to 10/7 post injury and must have had first-level interventions to treat it (head up, CSF drainage, etc)

If could not be controlled with hypothermia had barbiturates or hypertonic

Screen 2498 patients, 387 randomised

  • 188 randomised and analysed in hypothermia
  • 187 randomised and analysed in controls

No significant differences in baseline characteristics including age, severity of injury, APACHE, etc AND neurosurgical intervention prior to randomisation

Hypothermia did control ICP more than standard interventions in control group

Stopped early as greater incidence of unfavourable outcome (poor GOSE score) in hypothermia compared with controls

Unadjusted hazard ratio for mortality 1.45 (1.01,2.10) at 6/12

No difference in pneumonia rate between two groups

Untitled

Conclusion: Titrated hypothermia to reduce raised ICP in addition to standard care did not improve outcomes but and increased mortality

Hypothermia for Intracranial Hypertension after Traumatic Brain Injury