Corticosteroids for COVID-19

Some legendary names came out to play for this article. Meduri is the author of the famous Meduri Protocol for methylprednisolone in ARDS and Villar is the author of the article I shared on February 13th (seems like forever ago, really) where they provided dexamethasone for ARDS and showed a mortality benefit amongst many others. I personally like looking into strategies such as corticosteroids as they are inexpensive and available worldwide. You can't really count on third world countries obtaining a -zumab drug. This paper is an opinion piece and is missing formal RCT data. I recommend you read the article yourself and don't trust me. This is not medical advice but I am carefully administering corticosteroids to my COVID patients based on certain clinical and laboratory criteria. It is a custom tailored approach so I can't say exactly what I'm doing. Every patients is different. I am trying to reach for dexamethasone to avoid my team having to go into the room numerous times a day to give a medication. 

Steroids for Cytokine Storm
The authors state that the cytokine storm is what kills COVID patients. I do not disagree with this. You watch the ferritin and CRP spike up and the patient get sicker (we don't have IL-6 at our shop). Their O2 requirement goes up, their renal function starts to worsen. Things get ugly and in a hurry. Some use the -zumab drugs which we have all have a certain allocation of and is expensive, but what if we can reach for plentiful and cheap steroids instead? We all know the adverse reactions to this. The authors cite how the WHO guidelines on steroids is misleading and potentially harmful. 

The Evidence for Steroids in ARDS
We do not have great studies in all this. We have harped on this enough. The authors acknowledge this and pull observational data from Wuhan where there was a decreased risk of death for giving methylprednisolone to the patients in ARDS. They acknowledge that randomized controlled trials are ongoing but that we should not withhold giving patients steroids in the ICU for ARDS in lieu of study results. I know I'm not allowing my patients to wait themselves. 

Simple yes or no question to you all: Are your teams providing steroids to your COVID patients?

-EJ

Villar, Jesús MD, PhD; Confalonieri, Marco MD; Pastores, Stephen M. MD, MACP, FCCP, FCCM; Meduri, G. Umberto MD. Rationale for Prolonged Corticosteroid Treatment in the Acute Respiratory Distress Syndrome Caused by Coronavirus Disease 2019, Critical Care Explorations: April 2020 - Volume 2 - Issue 4 - p e0111 doi: 10.1097/CCE.0000000000000111

Link to Article



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Respiratory Management Protocol of Patients with SARS-CoV-2

First of all, a big hat tip to the authors:

Aurio Fajardo C; MD. Medicina Interna. Unidad de Paciente Crítico. MsC en Ventilación Mecánica, Universitat de València. MsC en Medicina Intensiva. Grupo Ventilación Mecánica Chile - Drive Flow Org. Viña del Mar. Chile. @drive_flow_org

Alberto Medina V; PhD. MD. UCIP. Hospital Universitario Central de Asturias. Oviedo. España @alberto_medina_villanueva

Angelo Roncalli; PT. MsC. Hospital Escola Helvio Auto Maceió. Brasil @angelo.roncalli

Enrique Monares Zepeda; Médico Intensivista. Ciudad de México. @enriquemonareszepeda

Federico Gordo-Vidal; MD. Hospital Universitario del Henares. Coslada- Madrid. Grupo de Investigación en Patología Crítica. Francisco de Vitoria, Madrid. España. @fgordo5

Vicent Modesto A; MD. Jefe Clínico UCIP Hospital Universitari I Politècnic La Fe. València, España.

Rodrigo Adasme J; MsC, Pt, CRT. Terapia Respiratoria Hospital Clínico Red de Salud UC-Christus. UNAB. Santiago, Chile.


This is a great review of 45 references to help us take care of patients with COVID-19. There is much left to be learned about this horrendous disease, but we can take cues from prior experience to help us guide our management of the ventilator to cause as little harm as possible. The group of experts listed above, using their multinational expertise, developed this evolving document including algorithms as well as guidelines that will be updated as we learn more. Best of all, it's free to us all. Thank you!

Link to Article

Link to PDF in English

Link to PDF in Spanish


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Proning patients on NIV or HFNC

Disclaimer: I am a consultant for a company mentioned in this paper but I am not being compensated in any way, shape or form for this post.

People have asked if it is safe to prone patients who are in ARDS and use either non-invasive ventilation or high flow nasal cannula. In this paper, which is completely FREE for you to download looked at 20 patients who were in ARDS (causes listed on the paper). This was not a randomized trial. It was an observational cohort. They included patients with with moderate ARDS per the Berlin Criteria.

Important teaching point is the Berlin Criteria for ARDS (PaO2/FiO2)
Mild P/F 200-300
Moderate P/F ≤200
Severe: P/F ≤100

Also important to know that moderate ARDS has a mortality of 32% and severe ARDS has a 45% mortality.

55% of patients avoided intubation (it's a small study). But when you consider the fact that these patients with COVID generally stay on the vent for more than 10 days anecdotally, require significant sedation and perhaps paralytics, and eventually move on to be trached, it may be worth consideration. 3 of the 9 patients who were intubated moved on to needing ECMO.

The short answer without me giving away any bias for the aforementioned reasons is that it could be done. The data supporting it is in this article. No, it is not a magic bullet. Not everyone will dodge the endotracheal tube. But one could start asking their patients to do this even in their Emergency Department.

Also, I cannot comment on the concern of aerosolization of the virus by NIV or HFNC at this juncture. I honestly don't know the answer. What I do know is that we may run out of vents if we intubate everyone early. Always wear as much PPE as you can reasonably get your hands on.

Ding L, Wang L, Ma W, He H. Efficacy and safety of early prone positioning combined with HFNC or NIV in moderate to severe ARDS: a multi-center prospective cohort study. Crit Care. 2020;24(1):28. Published 2020 Jan 30. doi:10.1186/s13054-020-2738-5

-EJ
Link to Abstract

Link to PDF

Link to Berlin Criteria

Multiple Patients on a Ventilator: FAIL

Sometimes medicine behaves like the stock market; a whole bunch of enthusiasm followed by a realistic pullback. This has now occurred with the concept of using one ventilator for multiple patients. I agree that we need to use some ingenuity in this crisis, but this one never sat well with me, hence me not commenting on it at all until now. Too many nuances go into oxygenating and ventilating patients with ARDS. I understand trying this to hold down the fort in a severe crunch, and I tip my hat to those who created the articles and YouTube videos. I'm not trying to be a contrarian or a Debbie Downer.

This statement was put out by the Society of Critical Care Medicine (SCCM), American Association for Respiratory Care (AARC), American Society of Anesthesiologists (ASA), Anesthesia Patient Safety Foundation (ASPF), American Association of Critical-Care Nurses (AACN), and American College of Chest Physicians (CHEST).

Amongst things mentioned here, all patients would need to be paralyzed for this to maybe work. What happens after the 48 hours of paralytics runs it course and they can't play nice on the vent anymore? One always needs an exit strategy. This is something I always teach when taking care of patients in the ICU. I digress, the list provided shows some other safety reasons.

We need to continue thinking outside the box, though, to save all the lives we can. I have never seen our community come together so well. We have done a great job supporting each other. Many have said it already and I agree with them, many of us are going to come out of this psychologically altered. Many of us are, what some would call, jaded in things of life and death. It's part of our daily lives in Critical Care. But this is taking that to another extreme. I appreciate the support that I have received from the community as well. Hope to keep providing you all with great content.

-EJ



Link to ASA Position Statement

Link to SCCM Position Statement

Link to PDF

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Prone Positioning for ARDS

I am a huge fan of proning patients who are in ARDS. At one point or another I'll cover the data behind proning like the PROSEVA trial (no time today or until at least June). There are a variety of ways to prone patients which reflect the disposable income of the facilities where you work and train. At the 3 institutions were I have worked and the others where I have done moonlighting shifts, we've all used some good ol' fashioned muscles and coordination.

The PDF quoted and linked here was published in December 2019 and is usually very key during flu season. I am not going to comment about the coronavirus but these patients are developing an ARDS-like syndrome where proning may work. I haven't seen any data, though. That being said, having the ability to prone patients and do it well could potentially save lives.

In the paper, they cover pretty much everything I would want them to in a document like this that's beneficial to all. They even discuss chest compressions and defibrillation in these patients, something we all fear.

The PDF is completely free and a direct link. I need to find out the citation for this bad boy. The authors did a great job and a big hat tip to them. There's a really nice safety checklist and nursing checklist included. 

How do you all prone at your institution?

Do you not prone at your shop because of fear of the tube coming out?

Have you ever had to perform CPR on a proned patient?




Link to FULL FREE GUIDELINES


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Dexamethasone in ARDS

This is a big impactful study. I'm happy it came out, really happy. To start off a big hat tip to my colleagues in España who put this together. ARDS sucks. It's a b-word to treat and patients spend a frustratingly long time to come off of the vent. Mortality rates are high. Morbidity rates are through the roof. Cost burden to the healthcare system is insane. The repercussions are unquantifiable. Many of these people never even return to work.

In my practice, when I have a patient with ARDS, I make sure to treat the underlying cause, protect their lungs with the vent, keep them as dry as humanly possible, and provide them with 4 days of vitamin C, hydrocortisone, and thiamine. The CITRIS-ALI study providing vitamin C showed a decrease in mortality in this population, less time in the ICU, and less time in the hospital (albeit with many caveats to that study). There's bench research that shows how vitamin C and corticosteroids are synergistic in preventing and repairing lipopolysaccharide-induced pulmonary endothelial barrier dysfunction. But we never had good data regarding giving these patients steroids to begin with. In theory it made sense, but we needed more help. We were simply doing our best and shrugging our shoulders in many of these cases.

Enter the DEXA-ARDS trial. They randomized patients with moderate to severe ARDS to either get dexamethasone or placebo. Note that they give the first dose immediately after randomization, something that they waited 12+ hours to do in the VITAMINS trial. I digress. Not bitter. Okay I'm bitter. Nonetheless, the pts who got steroids did better. They came off the vent quicker and had fewer deaths. Both statistically significant. One of the key takeaways regarding the vent free days is that we start thinking to trach pts around day 10-14. The dexamethasone group got off the vent around day 14. The control group around day 20. How many trachs were spared and the morbidity that comes with that? It's not specified in the article but I'm curious. Another key piece is the fact that there was no increase in side effects of the steroids.

Ultimately this trial is changing my practice. I was perhaps stopping steroids too early in the past.

-EJ



Villar J, Ferrando C, Martínez D et al. Dexamethasone treatment for acute respiratory distress syndrome: a mutlicentre, randomised controlled trial. Lancet Respir Med. 2020; (published online Feb 7.)

Link to Article (NOT FREE boooooo!)

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IV Vitamin C and ARDS: CITRIS-ALI

Here's my bias before I even read the article. I want to see a positive response in providing Vitamin C/ascorbic acid in patients who have Acute Respiratory Distress Syndrome. Why? Because I want me patients to do better with treatments that are inexpensive and easy to manufacture rather than the latest immunologic that ends in -mab and costs tens of thousands of dollars. If before you read this summary, you already think that Vitamin C is a bunch of bullpoop, you need some deep reflections in the mirror. You SHOULD want it to work. Now whether it does or doesn't is different and that's where the data comes in to play.

Ultimately, I'm sure I am going to write far more than what IG will allow me to write do you're more than likely going to have to go to my blog to read my thoughts.

The Study Drugs
Before we even get started, we need to look at the study drugs, or lack thereof. The cocktail that was used in the Marik trial that was monumental in finding a mortality benefit in sepsis included ascorbic acid at 1.5gm q6, thiamine 200mg, and steroids. There is a rationale as to why these three go together that Dr. Marik explains far better than I could ever explain. The three are necessary today. Heck, even Gianfranco Meduri has been using steroids for ARDS for years and it's not part of this study. Red flag number one. Not hating on the authors, I am just saying. Haven't finished reading on it yet. Reserve the right to change my mind. In fact, a quick search shows there's no mention of the word "thiamine" in the entire paper.

Outcomes
The primary outcome was modified sofa scores at 96 hours and biomarkers.
I am not going to go over the secondary outcomes but there are 46 of them. They're covering ALL the bases! Good job.

They enrolled 167 patients. This is remarkable that they were able to enroll this many patients in these 7 centers from 9/14 until 11/17.

Results
Let's talk results. That's why you're here. Are you going to start giving vitamin C to your patients with ARDS, yes or no?

Primary outcome: mSOFA and biomarkers: NO DIFFERENCE.
Secondary outcomes: 43 of 46 had NO DIFFERENCE.

But here is the kicker. The three secondary outcomes that had a difference are pretty important.
1. All-cause mortality (p=0.03). 46.3% in the placebo group vs. 29.8% in the Vitamin C group
2. ICU-free days (p=0.03). Patients were transferred out of the ICU faster in the Vitamin C group
3. Hospital-free days (p=0.04) 22.6 in the vitamin C group vs 15.5 in the placebo

Think of all the money that could be saved by this inexpensive vitamin in shortening time in the hospital. $6 a dose, if I'm not mistaken.

No difference in the biomarkers? Well, this may be my off-kilter idea but maybe we are looking or do not full understand our biomarkers.

There were NO adverse effects that occurred during the trial! I've had many people talk about kidney stones, renal dysfunction, terrible side effects of vitamin C. Well, there were none.

Now, there are many limitations in this study. The authors admit to that full and well. Physicians like myself who are on the pro-vitamin C side will interpret the data the way I just did. Those who are contrarians on the matter will be able to look at the numbers and interpret it differently. They will point out all the flaws in the study and throw the findings of the endpoints in the trash. I may be completely off base with my interpretation of these results, but I want to do EVERYTHING that's reasonable to take care of my patients. And if that means spending $24 a day on Vitamin C, I will do it.

If you were the patients on the ventilator with ARDS, would you want the doctor treating you to give you vitamin C?

-EJ




Link to Abstract

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Noninvasive Ventilation of Patients with Acute Respiratory Distress Syndrome

Link to Abstract

Link to PDF

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Noninvasive Ventilation in Acute Hypoxemic Respiratory Failure

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Early Neuromuscular Blockade in the Acute Respiratory Distress Syndrome

Link to Abstract

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ARDS: Formal Guidelines

Link to Abstract

Link to PDF

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Helmet vs Face Mask NIV for ARDS

I originally posted this article on 6/21/19 while preparing my NIV/BiPAP lecture. During that process, I learned and shared on IG about using a helmet rather than a mask for NIV (non-invasive ventilation). Looking at the footage that has been coming out of Italy and other parts of the world, you can catch a glimpse of their pumps, ventilators, and in the case of this post, the fact that many institutions are using the helmets.

Why are these places using helmets instead of face masks and what does the data say?

The study I am referring to was published in JAMA in 2016 and they compared utilizing a face mask vs a helmet setup in patients with ARDS. The study was actually stopped early because the data was so good. They were trying to get to 206 patients but stopped at 83.

The authors found that patients who wore the helmet were intubated less frequently, 18.2% vs. 61.5%, had more ventilator free days, a shorter length of stay in the ICU, and lower both in-hospital mortality and 90 day mortality. Patients were also on NIV with the helmet for a shorter period of time utilizing less PEEP, less pressure support, and required a lower FiO2.

Could the helmet be a tool to help out to minimize the need for intubation and mechanical ventilation? Does anyone here have experience with the helmet setup? This study was created in Chicago, I'm sure there's has to be someone around here who was at that institution while this study was being performed.

-EJ

Patel BK, Wolfe KS, Pohlman AS, Hall JB, Kress JP. Effect of Noninvasive Ventilation Delivered by Helmet vs Face Mask on the Rate of Endotracheal Intubation in Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2016;315(22):2435–2441. doi:10.1001/jama.2016.6338

Link to Article

Link to FULL FREE PDF

Link to PDF (Backup)




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