Professor John Laffey
Consultant Anaesthetist, Saolta University Health Care Group and Professor of Anaesthesia and Intensive Care Medicine, University of Galway
Olivia Lane
HSE Ambulance Service and ICU Patient Representative
Dr Bairbre McNicholas
Consultant Intensivist, Saolta University Health Care Group and Senior Lecturer, University of Galway
Studies at the Institute for Clinical Trials aiming to regulate blood pressure of patients with sepsis, are navigating ethical guidelines to advance medical treatment.
Studies to improve patient outcomes for sepsis require a delicate balance between explaining the possible risks and the benefits of clinical trial participation — often with loved ones under acute time pressure in ICU wards.
Intensive care challenges
“Clinical research ensures we can discover what the best current treatments are and how we can safely explore improvements in what we do,” says John Laffey, Professor of Anaesthesia and Intensive Care Medicine at the University of Galway. Co-convening a study to reduce the risk of low blood pressure during the management of patients with invasive mechanical ventilation, he aims to find a drug administration strategy that can maintain normal blood pressure.
“Our area of research is acute — it happens fast, so treatments must be given in the earliest phases of the illness. Patients may be temporarily incapacitated due to the severity of their illness, and so are unable, at that point, to give consent to participate in research.
Considering patients with lived experiences in ICU is a huge part of making the ethical case for participating in clinical trials while deferring patient consent.
“Research is essential to advance treatments for critical illnesses … If the next of kin gives assent on behalf of the patient, we can then enrol the patient in the study. When the patient’s condition improves, we can engage with them directly.” He adds that once patients can give consent, they make the ultimate decision and can withdraw if they wish.
Role of patient groups
Considering patients with lived experiences in ICU is a huge part of making the ethical case for participating in clinical trials while deferring patient consent until they are able to decide for themselves.
“I was a critically ill patient with sepsis and found out a few weeks later that I was paralysed. I believe that every study can help the next patient to get a better outcome,” says Olivia Lane, an ICU survivor and patient representative.
Randomised trial of blood pressure targets in sepsis
Dr Bairbre McNicholas, Senior Lecturer at the University of Galway is co-convening a study, to determine the optimal blood pressure for patients with sepsis. “We know higher blood pressure affects sepsis treatment. Using their previous blood pressure readings to determine their target during septic shock may improve outcomes. It’s a randomised trial, comparing this to current approaches, so if someone signs up, they will either receive normal care to the utmost level or they will get the more detailed evaluation of appropriate blood pressure levels.”
Professor Laffey concludes: “We find that next of kin are more conservative about taking part in trials than patients. However … they realise it’s the only way to help move science forward.”