However, it is unknown if one of the two main frequently used steroid regimens (hydrocortisone alone versus hydrocortisone and fludrocortisone together) is better than the other regimen. To compare the effectiveness of both treatment regimens, researchers used a large multicenter database made up of approximately 25% of U.S. hospitalizations.
This observational study design was intended to mimic a randomized clinical trial to compare the outcome of death or discharge to hospice between patients who received the regimen of hydrocortisone and fludrocortisone to those who 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 approximately four percent less time compared to patients who received hydrocortisone alone.
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These results provide robust evidence that one steroid regimen is superior to the other regimen and, in absence of further clinical trials, directly inform the choice of steroids in patients with septic shock.
Researchers believe this study has additional implications due to its use of target trial emulation, a modern approach to comparative effectiveness studies using observational data (“big” electronic health record data) that is designed to mimic a prospective randomized controlled trial.
These target trial emulations are likely to be seen with increasing frequency going forward as “big data” becomes more and more available and have the potential to answer complex clinical questions in situations where a randomized clinical trial may not be feasible.
Source: Eurekalert
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