Treating sepsis patients with steroids does not reduce mortality but does lead to quicker recovery in survivors and the need for fewer blood transfusions, according to a major international study.
The researchers behind the study, the largest ever into sepsis, said their findings could improve treatment for critically ill patients and save healthcare systems significant sums of money each year.
“We have finally shown what part steroids play in the treatment of these patients”
The study involved researchers from Australia, New Zealand, Saudi Arabia, Denmark and also St George’s University Hospitals NHS Foundation Trust and St George’s University of London.
Led by the George Institute for Global Health in New South Wales, it looked at whether the use of steroids – hydrocortisone – as an additional treatment for sepsis would improve survival rates 3,800 patients.
The researchers found the use of steroids did not lead to fewer deaths overall, compared to not receiving steroids. “The administration of a continuous infusion of hydrocortisone did not result in lower mortality at 90 days than placebo,” they stated.
However, patients given steroids had a more rapid resolution of sepsis, were taken off mechanical ventilation earlier, received less blood transfusions and were discharged earlier from intensive care.
The authors stated: “Some secondary outcomes were better in the group that received the active treatment. These hemodynamic effects may represent a beneficial role of hydrocortisone.”
“We will also need to find better and more effective care for those who go into septic shock”
Specifically, they found the time to the resolution of shock was, on average, on day shorter in the hydrocortisone group than in the placebo group – three days versus four days, respectively.
The time to discharge from ICU was, on average, two days shorter in the hydrocortisone group than in the placebo group – 10 days versus 12 days, respectively.
In addition, fewer patients in the hydrocortisone group than in the placebo group received a blood transfusion – 37.0% compared to 41.7% – said the researchers.
Hydrocortisone patients had a shorter duration of the initial episode of ventilation than placebo – six versus seven days – but the advantage was cancelled out after accounting for recurrent episodes.
There was no significant difference between the groups on the rate of shock recurrence, time to discharge, number of days alive and out of hospital, duration and rate of use of renal-replacement therapy, and the rate of development of new-onset bacteraemia or fungemia.
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The researchers noted that steroids had been used for over 50 years to treat sepsis – also known as septic shock – as they were thought to improve circulation by counteracting severe inflammation.
However, there was uncertainty about the optimal dose and duration of steroids and concerns that steroids may result in adverse complications to patients, highlighted the study authors.
St George’s Hospital
They noted that patients assigned to receive hydrocortisone had more adverse events than did those who those given a placebo, but that the events “did not affect patient-centred outcomes”.
In total 33 adverse events were reported, with 1.1% in the steroid group and 0.3% for placebo. Six were deemed serious, of which four occured in the steroid group and two in the placebo group.
The researchers said their trial findings, published in the New England Journal of Medicine, would add “high quality evidence” about the safe and effective use of steroids for patients with sepsis.
Lead author Professor Bala Venkatesh, from the George Institute, said: “Our results show there is still a lot to learn about septic shock, which kills up to half of those affected in some parts of the world.
Steroids do not cut deaths from sepsis but do speed recovery
“There are undoubtedly many other contributors to survival which we don’t yet understand,” he said. “But, we have finally shown what part steroids play in the treatment of these patients.
“If we can reduce the time in spent in intensive care units that not only frees up space for other patients, it saves health systems worldwide a huge amount of money,” he added.
Co-author Professor John Myburgh, also from the George Institute, said: “It is essential that we raise awareness of this disease so people can get treatment more quickly, but we will also need to find better and more effective care for those who go into septic shock.”
The study was supported by a grant from the National Health and Medical Research Council of Australia and also by indirect funding from the UK’s National Institute of Health Research.