Hello dear friends! Greetings from Vienna.
Last week this wonderful city, with beautiful cathedrals and amazing schnitzels, received the Annual Congress of the European Society of Intensive Care Medicine. Wonderful event, fantastic talks. In the afternoon of the last day The Hot Topics session was presented. Although my soul was already calling for a beer, I struggled and stayed to see the presentation of the newest and most important trials in the field. And here is a concise and direct summary for you all!
P.S.: These are some notes I took during the event, so if you want more details or specific criterias and numbers and tables, please take a look at the references. In fact this is more like scientific gossip than a scientific report.
1- Breathe trial – Presented by Gavin Perkins – Link
Very interesting trial indeed! Basically they screened patients in invasive mechanical ventilation for > 48h who failed the spontaneous breathing test. If they were able to protect airway they were randomized in 2 arms:
Extubation + NIV vs keep’em intubated and proceed with standard weaning. N 364 patients
Main outcome : time required to full weaning ( >48h without MV/NIV)
Both 2 groups reached the same safety outcomes. The NIV group obviously was extubated quickly, but they also needed less antibiotics and less sedation.
Clinical implication: Do we need spontaneous breathing test at all?
2- INPRESS Trial – Presented by Samir Jaber – Link
Fantastic trial ! Already published in JAMA. Individualizing pressure targets in the surgical room is better than usual care?
How they did: RCT. One group had pressure target according to their basal pressure (measured before surgery, during rest, with a range of 10% high or low). This group received central line and (if needed) norepinephrine to reach the goal. The control group had usual care regarding pressure during surgery.
Details: Major surgery only, > 2h, patients with ASA >= 2.
Excluded GFR< 30, cardiac surgery and patients who were already in shock or sepsis.
Main outcome: a composite of SIRS + at least 1 organ failure after 7 days of surgery.
Individual targets: 38,1% vs usual care : 51,7%.
The mean pressure was higher during surgery in the intervention group!
Clinical implication: hypotension during surgery may play an important role in organ disfunction. Should we also individualize for sepsis too?
Maybe our friends anesthesiologists will send patients with central line and norepinephrine rather than say the patient became hypotensive in the elevator.
3- Transfuse Trial – Presented by Jamie Cooper – Link
Another trial testing the impact of length of storage of packed red blood cells in critical care setting.
Right to the point: it was a huge trial (5000 patients) but no difference was found.
4- Reduce trial – Presented by Mark Van Den Boogaard – Link
Does prophylactic use of haloperidol can reduce delirium?
Good trial, good question, big N.
The problem: they did not selected patients with very high risk of delirium as they wanted. They also excluded dementia and neurological pathologies.
Intervention: 1- Haloperidol 1 mg 3 times/day from the first day of ICU until discharge/delirium 2- haloperidol 2 mg 3 times/day from the first day of ICU until discharge/delirium 3- placebo 3 times/day.
The 1 mg group was stoped by futility.
Main Outcome: 28 days mortality (????) ( some studies had show decrease in mortality with this approach)
Results: no difference at all, in the secondary outcome, delirium was equal between groups either.
5- ART Trial – Presented by Alexandre di Biasi – Link
The one we were all waiting for… A definitive study about the matter. Does lung recruitment saves lives in ARDS?
Very well conducted and performed multi center trial! Obviously not blinded.
All patients with P/F ratio < 200 were treated accordingly the ARDSnet protocol for 3 hours. In the end of this period if the P/F with 100% FiO2 was still < 200 then the patient was randomized to either: Control group= “ARDSnet” approach with peep table vs Intervention group = the following strategy:
Recruitment with crescent values of PEEP (PEEP 25 >> 30 >> 35) , then PEEP was reduced to 23 cmH2O and the lung compliance was calculated decreasing PEEP in intervals of 3 cmH2O every 3 minutes. After finding the optimal PEEP, another recruitment with 35 cmH2O of PEEP and then set the optimal PEEP (best compliance) + 2 cmH2O. Please, for a better understanding, read the trial.
Main outcome: 28-d mortality. N=1010 patients , 120 sites.
The intervention group had higher mortality compared to the control group 55.3 vs 49.3%!
Intervention decreased: mean ventilator free-days, driving pressure. Intervention increased: pneumothorax, barotrauma and P/F ratio, although no difference regarding refractory hypoxemia. There was no difference regarding experience of the sites
Clinical implications: this was a non solved issue regarding ARDS. Recent published meta-analysis showed some survival benefit with recruitment a year ago. We already have said here in the blog (link) the problems with that analysis. For me this study nails the coffin of recruitment in ARDS. Also, delivering a lower driving pressure with this approach did not improved outcomes, although we also pointed this possibilities in a recent post(link), the driving pressure was not the intervention here. Another important implication was how Gatinonni was happy with this finding.
5- ICE-CUB 2 trial – Presented by Bertrand Guidet – Link
Already published in JAMA.
Does a program to increase ICU admission rates among critically ill elderly patients have a beneficial effect on long term outcomes ?
I will be short with this one. They performed an amazing job. You must read it.
It’s a cluster trial where they randomized some ICUs to increase the admission rates of elderly critically ill patients.
The mean age was 85 years and the medium SAPS was around 60.
So we are talking about very old and sick patients. Due to age some of them are not usually addimited in many ICUs.
The main outcome was 6 month mortality, but they also accessed quality of life and a lot of other things.
Results: ICUs make no difference in these patients lives. Neither in mortality, nor in quality or functional status.
6- EGDT in septic shock showing Harm – Presented by Todd Rice – Link
Also in JAMA.
Fantastic trial with lot of good informations.
We all know about Rivers’ EGDT and how those results were not reproduced by ARISE, PROCESS and PROMISE trials. Here we have another one. However in this one, EGDT was harmful. Before you go yelling that for the whole hospital, WAIT! There are very important things you should know!
This was a single center, open label, RCT (just like Rivers) and was performed in Zambia’s one and only ICU. Patients had no access to mechanical ventilation and the only vasopressor was dopamine.
That being said, to the trial we go:
They prospectively randomized 209 adults with SIRS + suspected infection AND hypotension for two strategies:
EGDT simplified protocol ( 2L of crystalloids in 1 hour + 2 L in the next 4 h / antibiotic in the first hour / dopamine if required ( after fluids) / transfusion if Hb < 7 vs Standard care ( fluids guided by clinicians decision)
Main Outcome: 30d mortality
They excluded hypoxemic patients and if patient presented desaturation the fluids were stopped.
It was a very young population ( mean age 38 years); almost 90% were HIV positive with a mean CD4~70. Most presumed causes of infection were malaria and pneumonia.
EGDT group 30d mortality of 57% vs standard care 30d mortality of 41%
The EGDT received 1.5 L of crystalloids more than the standard group, they also used more dopamine ( 14% vs 2 %) and had bigger improvement on lactate level ( lactate was lower but mortality higher). Look our recent post about lactate (link).
Clinical implications: this trial does not change the actual knowledge for European and Americans, but as stated by the JAMA guy at the table, the journals and the Surviving Sepsis Campaign need to pursuit a global strategy regarding sepsis. Also, this is basically as EGDT trial in immunocompromised patients, we didn’t had this kind of trial before. I will keep my non EGDT mind. And so should you!
7- The feasibility trial SUPERNOVA – Alain Combes – Link
They are performing a trial with super protective ventilation ( 4ml\kg) using external removal of CO2 to keep control it under control. Basically they showed this approach is feasible.
I strongly recommend you: Do not take this post as the Fundamental Truth, instead, go for the references! We will probably do detailed posts about some of these trials during next weeks! Stay tuned! Hope you have a happy week. I know Gattionni will!