Colleagues.

We are are encouraging all Canadian hospitals caring for critically ill patients to participate in the ICU-Flu Observational Study. This is a Canadian Critical Care Trials Group study, sponsored by CIHR and the Public Health Agency of Canada, of critically ill adults and children with influenza (including H1N1). We will supply sites with a research ethics board application template and train a member at each site on web-based data entry that consists of a baseline assessment, a minimal number of days of data collection, including outcomes. Please contact Rob Fowler (rob.fowler@sunnybrook.ca) for adult sites and Philippe Jouvet (philippe.jouvet@gmail.com) for pediatric sites.

We also encourage sites to consider participating in Canadian trials and translational studies of influenza A H1N1. Currently, Anand Kumar is leading a randomized, double-blinded controlled trial comparing High vs Standard Dose Oseltamivir in severe, Influenza infection in ICU (the “ROSII Study”), and this study will employ the same base case report forms as the ICU-Flu study. Please contact Anand Kumar (akumar61@yahoo.com) to consider participating.

We will alert you to other opportunities as we learn of them.

Colleagues.

It was very helpful to hear of folks experiences with H1N1 at the CCCTG this week. The past couple weeks have seen a surge in cases in Winnipeg, Montreal and continued cases popping up across the country. Thanks to those caring for these patients and sharing their experiences.

The case report form that we have evolved has been used by our colleagues in Mexico and they have shared with us their experiences by sending us reports on 55 critically ill patients. From the Mexico experience, we have seen that patients who have become critically have typically presented with fever and respiratory symptoms (nearly 100%), bilateral infiltrates on chest Xray, and generally severe ARDS with impressively low PaO2/FiO2 ratios, frequently requiring adjunctive oxygenation support (prone positioning, high PEEPs). They have also noted increased AST/ALT and high CKs in the most severe cases. A surprising number have needed vasoactive /inotropic medication for hypotension. Most all of their patients were treated with neuraminidase inhibitors.  In Mexico, the mortality rate among critically ill patients with H1N1 has been 40-50% at 28 days. Thus far, we have not appreciated a mortality rate this high in Canada or other countries, but many of our cases have not yet reached 28 days. There may be other differences, either at the patient, environment, or healthcare system level that will explain potential differences in severity of illness, but it is too early to know.

I have attached a package that I encourage you to use to help report the Canadian experience with critically ill patients with H1N1. Included is
(1) a paper based case report form that we are currently using (June 18 version). It comprises a number of usual variables, and some that are specific to early experience with H1N1. The form can be used for both adults and pediatric patients. Thanks so much to Anand Kumar and colleagues for helping evolve the original versions based upon their experience, and to Philippe Jouvet, Karen Choong, Kusum Menon and others for pediatric contributions.
(2) We have also included a protocol that provides background for this observational project
(3) a sample research ethics board approval form
(4) the research ethics board approval at Sunnybrook Health Sciences Centre and Mount Sinai Hospital  
(5) a generic letter to the research ethics board that you can insert your address and name.

We would encourage you, even if you do not have a case in your ICU to submit this package to your hospital research ethics board so that you might be able to participate if cases do come to you. Please contact me if you are able to participate.

Over the next couple of weeks, we will enter data  from across the country into a common database and help colleagues seeing most of the cases complete a manuscript of the Canadian critical care experience with H1N1, on behalf of the Canadian Critical Care Trials Group. I will help the adult group and pediatric group (lead by Philippe Jouvet) develop a joint proposal funding to help support some of the data collection over the coming year. We are transitioning a pared-down version of this form to a web-based data entry system for use over the mid-summer and throughout the next year. This web-based version will be informed by the early experience you report.

For people interested in working on translational/basic science projects  - please email Anand Kumar at akumar61@yahoo.com.

Thanks for your observations so far. Let me know if there is anything that we can do to help, or with any questions about the data forms.

Rob

Robert Fowler, MDCM, MS, FRCPC
Assistant Professor
University of Toronto
Departments of Medicine and Critical Care Medicine
Sunnybrook Hospital
2075 Bayview Ave. Room D478
Toronto, Ontario, Canada, M4N 3M5
416-480-6100-7471 (phone)
416-480-6191 (fax)