Vitamin B1 boost for intensive care patients in trial to prevent and treat delirium

Left to right: James Allen, UHS Chief Pharmacist, Prof Cathy McKenzie, Professor of Intensive Care Pharmacy, and Prof Mike Grocott, Director of the NIHR Southampton Biomedical Research Centre

Southampton researchers are leading a new trial to see if giving certain patients vitamin B1 reduces the chances of delirium during intensive care.

Patients in the intensive care unit (ICU) often experience a syndrome called delirium. This causes hallucinations and can make patients very scared and confused.

Groundbreaking research will investigate whether giving intravenous (IV) vitamin B1, also called thiamine, to patients at very high risk of delirium reduces the chance of the condition occurring when they are severely unwell.

The nationwide trial has been awarded £2.7 million by the National Institute for Health and Care Research (NIHR).

The study is one of the first of its kind to be led by a UK pharmacist. It is a collaboration between University Hospital Southampton, the University of Southampton, the NIHR Southampton Biomedical Research Centre and the Intensive Care National Audit & Research Centre (ICNARC).

Understanding the cause

While the symptoms of delirium are usually temporary, the condition has life-changing with long-term consequences. There are currently no effective drug treatments for delirium.

Patients with delirium spend longer in ICU and hospital. It causes long-term memory problems and increases chances of dying in or after ICU. In older patients, delirium can mean they never return to their own home and lead an independent life.

Previously, researchers have suggested delirium is due to brain cells being unable to use energy properly. Vitamin B1 (thiamine) is essential for cells to break down sugar, so it could help prevent and treat delirium.

The new study is a randomised controlled trial (RCT) of vitamin B1 versus placebo. The researchers will see if thiamine does reduce delirium, and whether it works by improving the way brain cells use sugar.

Checking for signs of delirium

Treating delirium is one of the highest research priorities for patients, their families and ICU healthcare professionals.

The trial is called DELTA-ICU, which stands for DELirium and ThiAmine in the Intensive Care Unit. It is funded by the NIHR’s Efficacy and Mechanism Evaluation (EME) programme.

A total of 520 patients will take part at 20 NHS ICUs across the UK. They will be adult patients at very high risk of developing delirium.

Participants will be randomly assigned to receive either vitamin B1 or placebo. For the first five days, they will be given 300mg of vitamin B1 or placebo into a vein twice a day. This will then be reduced to once a day for up to nine more days or until they leave the ICU.

The research team will monitor participants for symptoms of delirium twice a day, using a measure called the Confusion Assessment Method for the ICU.

They will also record other information, such as how many days the patient is deeply sedated for and whether they survive at 14 days.  Researchers will also collect how long patients spend in ICU and whether they are discharged home after ICU. They will also collect data on long-term brain function and quality of life.

This will enable them to compare outcomes between patients in the two groups, to see if those receiving the vitamin B1 show fewer signs of delirium.

Southampton leading the way

The study will be led by Professor Cathrine McKenzie, Professor of Intensive Care Pharmacy at the University of Southampton. Professor McKenzie is the holder of the first full professorial role for a pharmacist in UK intensive care and one of the first pharmacists to lead this type of RCT.

Professor McKenzie is an Honorary Consultant Pharmacist in Critical Care at University Hospital Southampton (UHS) and part of the NIHR Southampton Biomedical Research Centre. Her journey has been supported by the UHS Research Leaders Programme and an NIHR Senior Clinical Practitioner Award.

Professor McKenzie said: “This research gives us the chance to assess a novel therapy for delirium, one of the worst syndromes of being severely unwell. As a pharmacist, it is an honour to lead this trial in partnership with ICNARC.”

UHS is home to one of the largest pharmacy departments in the country. The department has strategically grown its research capacity and capabilities in recent years to continue improving patient services and impact.

James Allen, Chief Pharmacist at UHS, said: “This trial marks a pivotal moment for our pharmacy department and serves as a testament to Professor McKenzie’s dedication and vision. Her leadership demonstrates the vital role pharmacists can play in advancing critical care research.

“This multi-centre study also reflects the strength of collaboration between the University of Southampton and UHS Pharmacy, driving significant progress in research capacity and leadership within both our departments.”

The study is being run with the Clinical Trials Unit at ICNARC. ICNARC is an independent non-for-profit scientific organisation that conducts clinical audit and research in intensive care.