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An indiscriminate killer

Rory Staunton died after receiving a scrape on his arm during a basketball game. His parents brought him to his paediatrician, who sent him to NYU Langone emergency room in New York for rehydration. Hospital staff missed several critical symptoms indicating he was developing sepsis, the most damaging of which was the failure to read a blood test that indicated very high white blood-cell count.

Rory was sent home, where his condition worsened. He became seriously ill and returned to the hospital the next evening. By then it was too late and he died of sepsis on 1 April, 2012, a month short of his 13th birthday.

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Rory Staunton

Since the death of their son, Ciaran and Orlaith Staunton, originally from Mayo and Louth, respectively, have set up the Rory Staunton Foundation and spearheaded an international awareness campaign about sepsis, a condition that claims more lives than lung cancer and more than breast cancer, bowel cancer and HIV/AIDS combined.

Ireland has embraced the campaign and become a leader in the fight against sepsis, Ciaran Staunton tells the Medical Independent (MI), citing in particular the adoption by the HSE of guidelines on the diagnosis and treatment of sepsis.

Mr Staunton points out that sepsis is the single leading cause of death in intensive care units in the US, killing more than 200,000 Americans each year. But despite that, a 2010 report found that 70 per cent of Americans did not even know it existed.

Much of that is now changing, due in no small part to the work, particularly in the US and Ireland, of the Rory Staunton Foundation.

Since it was launched, the Foundation’s campaign has been credited with saving thousands of lives and pressuring the US Centres for Disease Control and Prevention (CDC) to make sepsis awareness a priority. “To our amazement at the time, the word ‘sepsis’ did not appear in the CDC’s list of illnesses,” Mr Staunton says. “With a budget of $76 billion (€66.8 billion), not a penny was spent on sepsis.”

Regulations

The Foundation has also been responsible for a hearing on sepsis in the US Congress, a major forum on sepsis in Washington and the landmark adoption by New York State of ‘Rory’s Regulation’ on the management and treatment of sepsis in the state’s hospitals. These regulations are the first of their kind in the US and New York State is the first government in the world to have mandatory sepsis regulations.

These regulations require all hospitals to adopt best practices for the early identification and treatment of sepsis. The regulations also require special procedures for paediatric patients, including communication of critical test results and the posting of a parents’ Bill of Rights.

“We now know much more about sepsis. In New York, because of Rory’s Regulations, clinicians must first think ‘sepsis’ and act accordingly. Our mission is to make that mandate and mindset the national standard of care.

“Vast numbers of patients walking into emergency rooms across this country and the world show symptoms of sepsis. Too many, like our precious son Rory, are sent home only to return, gravely ill and with no hope. It is when government and the medical community come together that we can eradicate this vicious killer,” the Stauntons stressed at the US’s First National Forum on Sepsis last year.

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Ciaran Staunton at a US Senate hearing on sepsis

“We get emails and letters saying that ‘because of the information you put out, our child is alive today because we knew what questions to ask the doctors’. If we had known to ask our hospital and our doctor if Rory had sepsis, then Rory would be alive,” Mr Staunton says. “Our over-riding goal is to ensure that no other child or young adult dies of sepsis resulting from the lack of a speedy diagnosis and immediate medical treatment.

“Children cannot be expected to be advocates for their own care in emergency rooms and urgent care clinics, so it is essential that hospitals and medical clinics put diagnostic protocols in place to ensure the speedy treatment necessary to save children’s lives.

“We want to make a checklist for sepsis a key part of assessing patients, and to create a long-term informational strategy that will inform and educate parents to look for the signs of sepsis when their child is exposed to injury and bacteria.

“We also want to ensure that medical professionals check for sepsis and that educators have a basic training in first aid if a child is injured,” Ciaran says. “If there had been a greater awareness and understanding of sepsis earlier, Rory would not be dead.’’

Saving lives

Dr Kevin Tracey, a neurosurgeon and President and CEO of the Feinstein Institute for Medical Research at North Shore-LIJ Health System in Long Island, New York, told globalpost.com that the kind of sepsis awareness protocols advocated by the Rory Staunton Foundation have made a difference in his hospital.

“There is evidence that these measures, applied across large health systems, save lives. Deployment of major sepsis awareness protocols and rapid sepsis response teams within our hospital system, North Shore-LIJ, slashed the mortality rate from sepsis by 50 per cent.

“A major ally in combating sepsis is the Global Sepsis Alliance (GSA). The mission of the GSA is to provide a unified voice to those who treat sepsis and to elevate public and governmental awareness. A unified, global approach is absolutely necessary if we’re to stop a deadly, global pandemic. And a pandemic it is: Sepsis is currently one of the biggest killers of adults and children worldwide.”

If there had been a greater awareness and understanding of sepsis earlier, Rory would not be dead

Underscoring this point, Mr Staunton tells MI that his Foundation is aiming to build on its achievements in the US and Europe and focus also on the developing world. He wants the Irish Government to assist with this campaign.

“We’ve met Irish health officials and the Minister for Health and have asked the Irish Government to launch an initiative with the UN membership and the WHO regarding sepsis awareness.

“Under the initiative, any country the UN/WHO are giving aid to must have a sepsis awareness programme in place before they get funding. We’ve met with the Minister for Foreign Affairs, Charlie Flanagan, to discuss this and at the moment we have requested a meeting with the Irish Ambassador to the United Nations. Ireland gives a lot of money overseas, especially to developing countries, and a lot of it is health-related money. Sepsis is the largest killer of children in the world and if we are giving money to a country, we should insist that they should have a protocol on sepsis education in place.”

Meanwhile, the Foundation is targeting a number of US states with its sepsis awareness programme. “Introducing Rory’s Regulations in New York was an executive decision by Governor Andrew Cuomo. It didn’t have to go through state legislators. So we are meeting governors from a number of states at the moment. In a country of great wealth, there are 300,000 people dying each year from sepsis because no-one knows to look for it or to ask a doctor or a medical facility, ‘could this be sepsis?’ If we say the word, we save a life,” Mr Staunton emphasises.

UK and Ireland

The UK, too, has launched a major effort against sepsis, which kills 31,000 people annually in England alone. The plans were announced in December last year by Health Secretary Jeremy Hunt, who said that a new system for detecting sepsis in children under five is to be introduced in doctors’ practices and hospitals.

Sepsis accounts for 100,000 hospital admissions each year and costs the NHS an average of about £20,000 (€27,000) per patient.

It has been reported that in England, 1,000 children under five are admitted to paediatric intensive care units annually due to severe sepsis, of whom 10 per cent will die. It has become a more common reason for hospital admissions than heart attack, and has a higher mortality rate. “Sepsis kills more than 80 people in England every day,” the Health Secretary said. “It’s time to apply the lessons we’ve already learnt on patient safety and reduce the number of lives that are needlessly lost to this silent killer.”

The condition, which arises when the body’s response to an infection injures its own tissues and organs, can lead to shock, multiple organ failure and death, especially if not recognised early and treated promptly. It remains the primary cause of death from infection, despite advances in modern medicine, including vaccines, antibiotics and acute care.

Multiple studies have shown that programmes aimed at early identification and treatment of patients with sepsis lead to reduced mortality

International estimates of incidence vary but suggest approximately 300 cases per 100,000 population per annum. By comparison, myocardial infarction affects 208 patients per 100,000 per year and stroke 223. Mortality from sepsis is currently as high as mortality from acute myocardial infarction was in the 1960s.

According to the Centres for Disease Control and Prevention, sepsis affects more than 800,000 Americans annually and is the ninth-leading cause of disease-related deaths. The Agency for Healthcare Research and Quality lists sepsis as the most expensive condition treated in US hospitals, costing more than $20 billion (€17.5 billion) in 2011.

Sepsis incidence is predicted to grow at a rate of 1.5 per cent annually. This is partly due to an ageing population, increased numbers of invasive procedures and the increasing number of people living with comorbidities and on long-term immunosuppressive therapies. Multiple studies have shown that programmes aimed at early identification and treatment of patients with sepsis lead to reduced mortality, as well as deceased intensive care unit admission, ICU length of stay and hospital length of stay.

Sepsis represents a significant burden on Irish patients and the healthcare service, according to the HSE’s National Clinical Guideline No 6 Sepsis Management, published in November 2014. While hospital statistics do not capture underlying cause of death data in Ireland for 2013, up to 60 per cent of all hospital deaths had a sepsis or infection diagnosis, with approximately 16 per cent of all hospital deaths designated with a sepsis-specific diagnosis code. The total number of cases with a diagnosis of sepsis was 8,831 in 2013 and these cases accounted for a total of 221,342 bed days.

In addition, in 2013, the mortality rate of patients with a diagnosis of sepsis who were admitted to an intensive care environment was 28.8 per cent.

The corresponding figure for 2011 was 32.4 per cent and 31.3 per cent for 2012. However, this data is based on the discharge code of patients who had a diagnosis of sepsis and who were admitted to any type of intensive care environment at some point during their hospitalisation. It is not possible to conclude that these patients were admitted to ICU as a result of sepsis, or that sepsis was the cause of death.

“Sepsis is a leading global health and financial burden and is expected to increase further with an ageing population,” the HSE guidelines warned. “Fixed, direct costs associated with the spectrum of sepsis, such as increased ICU LOS, ICU staffing, medications and new technologies, are significant. Equally concerning are the indirect costs associated with sepsis such as loss of earnings, productivity and mortality. In fact, indirect costs may account for up to 70 per cent of the total costs of sepsis.

“European studies estimate that a typical episode of severe sepsis will cost a healthcare institution around €25,000. One-year healthcare use has also been shown to be elevated after severe sepsis. In addition, long-term mortality in previously healthy patients with severe sepsis/septic shock has been shown to be worse than that of patients with non-septic critical illness and of the underlying general population.”

‘Indiscriminate killer’

Dr Vida Hamilton, Consultant Anaesthetist, Waterford Regional Hospital and National Clinical Lead, Sepsis, chaired the Sepsis Guideline Development Group and is on the front line in the battle against sepsis. “I would categorise sepsis as an indiscriminate killer, irrespective of age, socio-economic group, underlying good health status or whether you have chronic health morbidities. It kills one-in-five patients with severe sepsis sceptic shock. About eight million people in the world are estimated to die from sepsis each year,” Dr Hamilton tells MI.

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Dr Vida Hamilton

“We don’t have robust data in Ireland. What we do have is data on our mortality rates from patients presenting with severe sepsis sceptic shock who have some part of their treatment in the critical care area. That rate is 28.8 per cent; that’s 2013 data and is in line with the European norm. The Impress study on sepsis identified a mortality rate of 28 per cent in Europe, 30 per cent in Asia and 24 per cent in the US, though the study group in the US was slightly different from that in Europe.

“The mortality rate from severe sepsis sceptic shock now is where myocardial infraction was back in the 60s. The difference from what’s happened since the 60s in the management of acute myocardial infarction is that time-dependent pathways were introduced that resulted in the reduction of mortality rates. And we have very robust evidence now that introducing time-dependent pathways in the recognition and management of patients with sepsis, particularly severe sepsis sceptic shock, reduces mortality rates to approximately 20 per cent.”

Dr Hamilton says the focus in Ireland this year is on implementing the 2014 National Clinical Guideline No 6 Sepsis Management. “The guidelines were launched last November and this year represents implementation year. We have to ensure there are appropriate resources, education and audits to ensure that people are aware of the pathways and then are able to follow them. That process will occur during this period, with a view to being implemented by 2016.

“The guidelines are evidence-based and the evidence demonstrates that mortality rates, particularly for patients presenting to the emergency department with severe sepsis/sceptic shock, can be reduced to 18-to-20 per cent by following these guidelines. We would be looking for a reduction in mortality rates of between 20-to-30 per cent with the full implementation of these guidelines. It will take a number of years to achieve that drop, probably a minimum of two-to-five years.

“The fundamental approach that the guideline is recommending in management of patients with sepsis is the sepsis 6 approach. This is a very simple approach, where we ask for three things to be given and three things to be taken in all patients diagnosed with sepsis.

“The three things to give are: Oxygen, if they require it; IV antibiotics, as per hospital guidelines; and IV fluids, as they require it. And the three things to take are: Blood cultures before IV antibiotics are administered; routine bloods and a blood lactate level; and to take account of the patient’s urinary output. That is our fundamental approach to all patients with sepsis.

“The second step then is to risk-stratify the patient as to whether they have severe sepsis or severe sepsis sceptic shock and when you risk-stratify a patient into the more severe manifestations of sepsis, then you have additional management tools.”

Dr Hamilton views the guidelines as a milestone for sepsis recognition and treatment in Ireland. “These are hugely important and we have very robust data supporting the following of guidelines in the recognition and treatment of patients with sepsis and a reduction in mortality rates.

Pathways

“It’s a phased process. The first two pathways have been agreed — the emergency pathway for patients presenting to the emergency department with symptoms and signs consistent with sepsis, and the other pathway is for the management of adult inpatients.

“We have three other pathways that are in evolution at the moment. The paediatric guideline is published and it is hoped that this pathway will be published by the middle of this year, and the maternity pathway is in evolution, and the pre-hospital pathway also. We are hoping to have all those done certainly by the end of this year, if not by the middle of this year. The guidelines are already there, so these are specific pathways to facilitate the implementation process.”

I would categorise sepsis as an indiscriminate killer, irrespective of age, socio-economic group, underlying good health status or whether you have chronis health morbidities

In view of the number of sepsis-related tragedies in Ireland, why did sepsis awareness slip so far off our radar?

“I think it is true to say that sepsis has suffered from a lack of awareness within the medical community. Sepsis kills more people than breast cancer, bowel cancer and HIV/AIDS every year and yet the amount of money put into research and awareness of those three conditions far, far exceeds the kind of awareness and investment in research on sepsis. This is true of Ireland, the UK and the US.

“As a result of high-profile cases associated with poor outcomes from sepsis, the Minister for Health at the time, Dr Reilly, asked the HSE to set up the National Sepsis Steering Committee and the National Sepsis Management Guidelines are a product of the Guideline Development Group from that Committee. There are six national guidelines and sepsis was the sixth one published. The implementation of those guidelines is listed as a ministerial priority for 2015.”

So is Ireland now becoming a leader in sepsis awareness, as Mr Ciaran Staunton suggested? “Yes, I believe so. We are the first country to publish the National Clinical Guideline No 6 Sepsis Management, so we are definitely leading the field in this area. Great steps have been taken and I think we have to recognise that. We are absolutely at the European norm and that’s before we have implemented our guideline and our pathways. So I would say we are ahead of the curve and are now leading the field.”

But much remains to be done, Dr Hamilton stresses. “I would like to encourage all healthcare workers involved in the care of patients to read the summary guidelines and review the pathways on the website www.hse.ie/sepsis. I am planning to visit all the hospitals in a formal way to present sepsis awareness and education lectures and to discuss with the relevant stakeholders how they can implement the guidelines.

“My priority now is to increase awareness, increase education, to ensure that the resources are available for clinicians to be able to implement the guidelines and then to facilitate that implementation.”

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