The long-awaited results are finally here for the PLUS trial, an application in Spiral’s study manifest.
The aim of PLUS was to conduct a multi-centre, blinded, randomised, controlled trial (RCT) to determine whether fluid resuscitation and therapy with a "balanced" crystalloid solution (Plasma-Lyte 148®) decreases 90-day mortality in critically ill patients requiring fluid resuscitation when compared with the same treatment using 0.9% sodium chloride (saline).
The newly published results have determined that intravenous fluids used in intensive care such as the commonly used saline is as effective at keeping people alive and their organs functioning as more expensive ‘balanced’ solutions.
The results not only provide doctors with greater certainty about the safety and benefits of saline solution but also have broader implications for treatment availability and costs around the world.
“Just about every patient admitted to the Intensive Care Unit (ICU) will receive intravenous fluids for resuscitation or as part of standard treatment,” said Professor Simon Finfer AO, an ICU physician and senior researcher at The George Institute.
“However, the best choice of fluid has been a longstanding issue of debate as some fluids were approved and licensed for use based on trials in small numbers of patients looking only at short term outcomes.”
Reports of intravenous solutions being used to treat critically ill patients date back almost 200 years ago. However, due to a lack of robust data, controversy over the choice of intravenous fluids has continued in the medical industry. The question has remained: In critically ill adults, does the use of balanced crystalloid solutions compared with saline reduce mortality and/or the occurrence of acute kidney injury?
To determine this, researchers at The George Institue for Global Health designed a clinical trial with the team at Spiral - the Plasma-Lyte 148® versUs Saline (PLUS) study - which involved over 5,000 patients across 53 sites in Australia and New Zealand.
They recruited adult patients admitted to participating ICUs during the study period who needed intravenous fluid resuscitation for their underlying medical condition. The patients were followed for a period of 90 days after treatment as previous research had shown around one in four would be at risk of dying within this timeframe.
The research team primarily looked at rates of death in patients who were given the BMES or saline while they were in the ICU. At 90 days after the treatment, the same number of patients in the BMES and saline groups had died.
The number of days that the patients required mechanical ventilation, kidney dialysis, their survival time in the ICU and in hospital, as well as major measures of healthcare costs were similar between the groups.
“We found no evidence that using a balanced multi-electrolyte solution in the ICU, compared to saline, reduced risk of death or acute kidney injury in critically ill adults,” said Prof Finfer.
These results have far-reaching implications for the medical industry. Each year in Australia 160,000 people are admitted to ICU. It is one of the most expensive aspects of healthcare with one day in ICU costing a minimum of $4,000. With high demand for ICU beds, resources and expertise, even a small difference in outcomes may result in important clinical and economic effects at the population level.
Spiral is proud to be a part of this study, making a tangible contribution to the medical industry, its professionals and patients.