Sepsis occurs in roughly 1.7 million hospitalizations within the U.S. with in greater than a 3rd of hospitalizations leading to death. Patients with septic shock profit from steroid medications (corticosteroids) to scale back shock duration and potentially decrease the possibility of dying. Nonetheless, it’s unclear if considered one of the 2 important ceaselessly used steroid regimens (hydrocortisone alone versus hydrocortisone and fludrocortisone together) is healthier than the opposite regimen.

A recent study in JAMA Internal Medicine by researchers from Boston University Chobanian & Avedisian School of Medicine shows that patients receiving a mix of hydrocortisone and fludrocortisone had lower death rates and discharge to hospice in comparison with those that only received hydrocortisone.

Our results provide robust evidence that one steroid regimen is superior to the opposite regimen and, in absence of further clinical trials, directly inform the alternative of steroids in patients with septic shock.”

Nicholas Bosch MD, MSc, corresponding writer, assistant professor of medication, Boston University Chobanian & Avedisian School of Medicine

To check the effectiveness of each treatment regimens, the researchers used a big multicenter database made up of roughly 25% of U.S. hospitalizations and an observational study design that was intended to mimic a randomized clinical trial to check the consequence of death or discharge to hospice between patients who received the regimen of hydrocortisone and fludrocortisone to those that received hydrocortisone alone.

They found that the regimen of hydrocortisone and fludrocortisone together was superior to hydrocortisone alone; on average, patients who received hydrocortisone and fludrocortisone died or were discharged to hospice roughly 4 percent less of the time in comparison with patients who received hydrocortisone alone.

In line with the researchers, these findings may change clinical practice. “It is feasible that guideline recommendations, which currently suggest to start out hydrocortisone alone, will change consequently of this study,” said Bosch, who is also a pulmonologist at Boston Medical Center.

The researchers consider this study has additional implications as a result of its use of goal trial emulation, a contemporary approach to comparative effectiveness studies using observational data (“big” electronic health record data) that’s designed to mimic a prospective randomized controlled trial. “These goal trial emulations are more likely to be seen with increasing frequency going forward as “big data” becomes an increasing number of available and have the potential to reply complex clinical questions in situations where a randomized clinical trial is probably not feasible,” Bosch said.

Funding for this study was provided by National Institute of Health (NIH) National Center for Advancing Translational Sciences (NCATS) grant number 1KL2TR001411, 1UL1TR001430, and the Boston University Chobanian & Avedisian School of Medicine Department of Medicine Profession Investment Award.

Source:

Boston University School of Medicine

Journal reference:

Bosch, N. A., et al. (2023) Comparative Effectiveness of Fludrocortisone and Hydrocortisone vs Hydrocortisone Alone Amongst Patients With Septic Shock. JAMA Internal Medicine. doi.org/10.1001/jamainternmed.2023.0258.