At East Lancashire Health Trust, we believe in safe, personal and effective care. The care we deliver is backed up by the latest evidence.
To maintain this standard, we are involved in many different research trials that continue to keep us on the cutting edge of critical care medicine. Below is a list of the current trials we have ongoing at the trust, as well as our excellent research team that oversee them.
Click on the headings below to learn more about clinical research and trials:
Each year, around 184,000 patients are admitted to NHS intensive care units (ICUs) and over 30% require help with their breathing using a ventilator (breathing machine). Giving oxygen through the ventilator is an essential part of this treatment. However, we do not know how much oxygen should be given to patients to optimise their recovery. Both too much, and too little, oxygen may cause harm. The concentration of oxygen given through the ventilator is adjusted according to how much oxygen can be detected in a patient’s blood, known as oxygen saturation. Some studies have shown that in unwell hospitalised patients, having a lower, rather than higher, oxygen saturation may be beneficial.
UK-ROX is conducting a large-scale, clinical trial to find out whether using a lower oxygen target (conservative oxygen therapy) to guide oxygen treatment might lead to better outcomes for patients when compared with the approach currently used in the NHS (usual oxygen therapy) when treating ICU patients on a ventilator. The study will include 16,500 patients from around 100 UK ICUs. Patients will be randomly assigned to either the conservative or usual oxygen therapy group. We will follow all patients up to 90 days later by ‘linking’ study data with routinely collected national records. We will find out if conservative oxygen therapy was more effective than usual oxygen therapy by comparing the number of patients alive in each group at 90 days.
Patient recruitment started in May 2021 and is due to end in 2023. Results will have a large and immediate impact on ICU clinical practice and on patient outcomes throughout the NHS.
The commonest way to measure the level of oxygen in a person’s blood is by using a pulse oximeter; a clip that is usually placed on a fingertip and provides a value where 96-100% is considered normal.
An increasing number of studies have shown that for people with darker (pigmented) skin, pulse oximeters may over-estimate their true oxygen level. This is because the pulse oximeter shines light through the fingertip and skin tone may affect the device’s accuracy. Over-estimation of oxygen levels could under-estimate the seriousness of a person's illness, leading to them not receiving the correct treatment and come to unnecessary harm.
This study aims to find out whether skin tone affects the accuracy of pulse oximeters and confirm whether they over-estimate the level of oxygen in people with darker skin.
EXAKT will be running as part of another larger study (called UK-ROX) that was designed to look at how oxygen levels affect patients on breathing machines in intensive care units (ICUs). Patients eligible to be enrolled in this study will be offered the opportunity to participate in the EXAKT study.
We will study several different pulse oximeters used by the NHS and for each patient, two of these will be placed on their fingers and the oxygen level will be compared to the oxygen level in a routine blood sample taken at the same time. These blood samples (‘arterial blood gas samples’) are a normal part of caring for patients in ICU and are taken several times each day. The patient's skin tone will be measured using a special device (called a handheld spectrophotometer) that accurately measures colour. We plan to enrol approximately 900 patients to this study from 24 ICUs participating in the UK-ROX trial over 12 months.
Patient recruitment will start in early summer 2022 and end in 2023.
Around 184,000 critically ill adults are admitted to critical care each year in the UK. Around half have a sudden worsening in kidney function that happens as part of their illness defined as acute kidney injury (AKI). This rapid decline in kidney function frequently causes more acid to build up in the blood (known as acidosis) which can cause further harm.
Critically ill patients with acidosis in the context of also having AKI have a very poor prognosis, with a 90-day mortality of 59%. In these patients, kidney replacement therapy (KRT) is the most commonly used treatment. Another option is to treat the acidosis directly by administering “buffer” solutions (e.g. sodium bicarbonate), with the aim of raising extracellular pH to restore cardiovascular function and oxygen delivery to tissues. This has the potential to both increase survival and avoid KRT, which is invasive and resource-intensive.
A recent trial evaluating the use of sodium bicarbonate in critically ill patients with acidosis found a significant reduction in 28-day mortality (46% sodium bicarbonate vs. 63% control) and use of KRT in a subgroup of patients with AKI. However, such sub-group analyses must be treated with caution, and the authors rightly called for a larger RCT to address this question. Currently, there is uncertainty among critical care clinicians as to whether sodium bicarbonate should be used for routine treatment of acidosis in patients with AKI, and there is little high-quality evidence for the use of sodium bicarbonate in patients with acidosis and AKI which likely leads to varied use in critical care units worldwide.
The Multicentre evaluation Of Sodium bicarbonate in Acute kidney Injury in Critical Care (MOSAICC) RCT will address the clinically important question of whether treatment with IV sodium bicarbonate is superior to no IV sodium bicarbonate in critically ill adults with metabolic acidosis and AKI. This will be measured in terms of all-cause mortality at 90 days (clinical effectiveness) and incremental costs, quality-adjusted life years (QALYs) and net monetary benefit at 90 days (cost-effectiveness). This evaluation will have a large and immediate impact on clinical practice and on patient outcomes in the NHS and worldwide.
Vitamin D deficiency (low vitamin D levels) is common in patients who are unwell (around 70%). This has been found to be related to an increased risk of infection and death. There are many reasons why patients are poorly and those who do survive can suffer long-term health problems in the future. It is not known whether being vitamin D deficient is a cause or effect of being unwell, and research into whether vitamin D is useful is not clear.
There are no guidelines to measure and treat patients admitted to intensive care who are critically ill and are vitamin D deficient. Vitamin D is cheap and easily available, and if using vitamin D is found to help, can be quickly put into standard practice in hospitals. VITDALIZE is an international trial that aims to recruit 2400 patients from across Europe. Countries that are participating include the UK, Austria, Germany and Belgium.
The UK part of VITDALIZE aims to recruit 600 patients into the trial. The aim of this trial is to see if giving a high dose of vitamin D in critically ill patients can improve survival, length of hospital stay, and quality of life.
Some patients that undergo surgery develop a syndrome called vasoplegia. Vasoplegia occurs when the function of blood vessels becomes impaired and the blood pressure falls to abnormally low levels. Vasoplegia requires the use of additional medications (vasopressors) to maintain blood pressure.
Where vasoplegia persists after surgery, it often necessitates admission to the intensive care unit for management of vasopressors, resulting in prolonged hospital stays and leading to a great potential for complications including the development of atrial fibrillation (AF), an irregular heart rhythm (arrhythmia) that increases the risk of stroke and death.
In the SQUEEZE UK study, we wish to identify factors (e. g. patient age, sex, medical conditions, type of surgery and intraoperative management) that are associated with the requirement of vasopressor medications or lead to the development of AF during or after surgery.
Severe lung failure called acute respiratory distress syndrome (ARDS) is frequently encountered in intensive care units throughout the world. Various causes such as infection in the lung or elsewhere in the body, trauma, or blood transfusion can lead to this clinical condition. While overall supportive care has improved the outcomes, there is still no definitive drug-based treatment for this condition. Various trials of drug therapies have failed to demonstrate a benefit and this is likely to be due to our poor understanding of the underlying mechanisms that drive this disease. Current treatment is limited to supportive care with lung support (ventilation), antibiotics and other routine care as required.
The research efforts of the critical care community over the last decade has led to the identification of sub-types of ARDS that might help us provide personalised therapy and reduce death and disability. The laboratory tests required to identify patients of a specific sub-type are currently not available as a routine test or a rapid bedside test. Rapid bedside identification of patients with a specific sub-type of ARDS could influence the therapy provided to them including drug therapy and also enable the development of newer therapies.
In this trial we will test blood samples from patients with ARDS to confirm the presence of the subtypes of ARDS identified in previous studies and also test a novel, rapid bedside test. From this we can work out how accurate or useful these new tests might be.
GenOMICC is a research study that looks at the DNA of people with severe infections and injuries. Infectious diseases and severe injuries affect millions of people around the world every year. Most cases are mild, but some people become very unwell and are admitted to intensive care. Our genes (DNA) can determine how much critical illness affects us.
We want to find the genes that cause some people to be more sick. If we do, we may be able to develop better treatments for patients in the future.
Community-acquired pneumonia (CAP) is a syndrome in which individuals who have not been hospitalised recently develop an acute infection of the lungs. Bacterial and viral infections are responsible for the vast majority of CAP.
CAP is a leading cause of death from infection globally, with lower respiratory tract infection implicated in approximately 3 million deaths in 2016. This makes it the fourth most common cause of death world-wide, and the leading cause of death in developing countries.
CAP that is severe enough to require admission to an Intensive Care Unit (ICU) is associated with substantial risk of mortality.
All patients who are treated in an ICU will receive therapy that consists of multiple different treatments, as many as 20 or 30.
These treatments act together to treat both the infection and its effects on the body. When treating a patient, doctors choose from many different treatments, most of which are known or believed to be safe and effective. However, doctors don’t always know which treatment option is the better one, as individuals or groups of individuals may respond differently. This study aims to help doctors understand which treatments work best.
REMAP-CAP uses an innovative trial design to efficiently evaluate multiple interventions simultaneously.
We are investigating the psychological impact of having been treated for Coronavirus disease 2019 (COVID-19). The purpose of this study is to improve our understanding of the psychological impact on patients of being diagnosed with COVID-19 and receiving treatment in intensive care. We are planning to ask patients who have left intensive care questions to assess symptoms of anxiety, depression and trauma that they may be experiencing. We will also ask some questions which will enable us to identify potential risk factors for anxiety, depression and trauma following an intensive care admission due to COVID-19. We hope that by learning more about the psychological impact on people who have survived intensive care, we can improve our understanding and use the information to help inform healthcare planners about the number of intensive care survivors who might need psychological support once they go home.
This study aims to compare several different treatments that may be useful for patients with COVID-19 and/or influenza pneumonia. These treatments have been recommended for testing by the expert panel that advises the Chief Medical Officer in England. Although these treatments show promise, nobody knows if any of them will help patients recover more effectively than the usual standard of care all patients at your hospital will receive.
The treatments for COVID-19, which may be given in addition to the usual care at your hospital, include a high dose steroid, dexamethasone (if you need help with your breathing), a treatment for diabetes or heart failure called empagliflozin, a synthetic antibody treatment directed against the virus (called sotrovimab) and two antiviral treatments called molnupiravir and Paxlovid.
The treatments for influenza pneumonia, which may be given on top of your usual care, include two anti-viral treatments, oseltamivir and baloxavir and low-dose dexamethasone. At present, we don’t know whether any of these will work. However, the side-effects are already well-known from other uses and so your doctor will be able to monitor you appropriately.
The SIGNET study opened to recruitment in September 2021.
SIGNET will be the largest randomised controlled trial in organ donation, positioned perfectly to coordinate the unique strengths of the UK NHS infrastructure. It will evaluate the benefits of Simvastatin given to organ donors on outcomes in organ recipients.
There is evidence that Simvastatin, a safe and commonly used drug, might limit the damage sustained by a donor heart before it is transplanted.
This drug has not been tested in large scale trials which assess outcomes important to patients.
The SIGNET study will evaluate the benefits of a single dose of Simvastatin given to potential organ donors declared dead by neurological criteria on outcomes in organ recipients.
Around 1 in 5 patients with sepsis will die. If patients are critically unwell with low blood pressure (‘shock’) this figure increases to 1 in every 3 patients. The Early Vasopressor in Sepsis (EVIS) study compares two different approaches to treatment for sepsis patients to see which best aids survival, reduces time spent in hospital and improves quality of life.
Survivors can face lifelong complications including depression, weakness and chronic pain. Like heart attacks and strokes, sepsis needs to be treated quickly after it develops. Current UK and international guidelines therefore focus on the public and professionals recognising sepsis early and delivering early treatment with, amongst others, antibiotics and fluids delivered via a drip into a vein. Medications to improve blood pressure such as norepinephrine (vasopressors) are currently recommended later in treatment after initial attempts to stabilise the patient have been made.
The standard approach currently is to give a salt solution fluid through a drip in the patient’s arm to start with, adding in a medication that increases the blood flow to vital organs (the vasopressor medication norepinephrine) if required. The alternative approach is to start the vasopressor medication immediately, and then add in extra salt solution fluid via a drip if required. Vasopressors work by increasing the blood pressure which allows a better blood flow to the internal organs. The research team plans to see which approach is better and to see if they have a role in improving a patient’s recovery time and reducing complications, the length of time they stay in hospital and longer term poor health.
People treated in intensive care need a great deal of special care and support. After discharge from hospital, some people find their muscles are still weak and their ability to exercise and to do everyday things may still be affected. They can also have confused memories of their time in the intensive care unit. For most people, these problems get better on their own, but for other people, they may continue for a long time after leaving hospital.
We want to find out if a rehabilitation programme can help people recover more quickly after they are home from hospital. This trial will test a programme of ‘remote’ support, where patients talk to healthcare staff over video or telephone. They will also have help to do some exercises to help their recovery. This trial will be the first to test a remote approach to rehabilitation. We want to find out if remote support is better than usual NHS care for people recovering from a critical illness.