The FRESH Clinical Trial: An Investigator’s Perspective

Fluid therapy is a staple in many healthcare settings, particularly in the hospital. A clinical trial on the benefits of dynamic fluid management in septic shock patients – the Fluid Responsiveness Evaluation in Sepsis Hypotension and Shock (FRESH) study – is a featured article in CHEST Journal’s October 2020 issue. 

The FRESH study, which was performed at 13 hospitals across the United States and United Kingdom, demonstrated lower net fluid balance, reduced mechanical ventilation and reduced kidney injury in septic shock patients when a non-invasive dynamic assessment was used to guide intravenous fluid and vasopressor administration. We asked one FRESH investigator, Prof. Lui Forni, BSc, Ph.D., MB.BS, MRCPI, AFICM, his perspective on the study and its implications. Here’s what we learned.

Q: Why did you participate in the FRESH study?

Prof. Forni: When FRESH was first introduced to me, I thought it was a very interesting approach to a common problem: volume resuscitation in patients with sepsis. Having a tool you could easily use, and could be used by all members of the team -- not only in but also outside of the ICU -- was a very attractive proposition and one that we certainly want to continue using.

Q: What is your take on the importance of dynamic fluid management?

Prof. Forni: Loading patients up with fluid to later take it off, which is one of the approaches the clinical community used to have, is really not the way forward. I think the way forward is something akin to stroke volume measurement… using a simple technique like the passive leg raise to assess fluid responsiveness, and then guide your fluids to the patient's needs. I think that’s got to be the way forward.

Q: Why do you think the FRESH study is important?

Prof. Forni: I see it as a real game changer. There wasn't a great deal of difference in fluid volume used between the patient groups, and the sample size wasn't particularly large, yet the results are quite staggering. For example, the need for renal replacement therapy, something that is particularly close to my heart, was around 17% in the control arm. In the intervention arm, it was 5%... a dramatic reduction in the need for renal replacement therapy. Similar results were also seen with mechanical ventilation. So, two treatment options used in intensive care, particularly in patients with sepsis, were reduced significantly by using stroke volume guided resuscitation techniques. These findings could have real implications for treating patients moving forward.