SAN ANTONIO (FRONTLINE MEDICAL NEWS) – While critical care specialists await more data on a so-called sepsis cocktail with varying degrees of hope and skepticism, Paul E. Marik, MD, FCCP, has proclaimed the dawning of a new era.

Dr. Marik became a celebrity in the critical care medicine community after he and his colleagues reported the results of his retrospective study evaluating the combination of hydrocortisone, vitamin C, and thiamine for treatment of severe sepsis and septic shock (Chest. 2017 June. doi: 10.1016/j.chest.2016.11.036 ).

Since this study, several physicians have already been putting Dr. Marik’s method to practice, the investigator and audience members noted during a session at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

“My point is, steroids work, but they don’t work well alone, and the era of glucocorticoid monotherapy has come to an end,” Dr. Marik said in his presentation at the meeting.

These comments echoed Dr. Marik’s May 2017 editorial in Critical Care Medicine , in which he suggested that critically ill and injured patients may benefit from combination therapy with hydrocortisone and vitamin C (Crit Care Med 2017 May;45[5]910-1).

That editorial was quickly followed by the report on Dr. Marik and colleagues’ before-after study, in which hospital mortality was 8.5%, versus 0.4% in the treatment and control groups, respectively (P less than .001). This finding led the investigators to suggest that intravenous vitamin C administered along with corticosteroids and thiamine is “effective” in reducing mortality, in their paper published in CHEST®.

During Dr. Marik’s presentation at the meeting, he noted that he had been “misquoted” with regard to the finality of his study’s results. The final line of the CHEST® paper reads, “Additional studies are required to confirm these preliminary findings,” he emphasized.

Nevertheless, Dr. Marik alluded to a “big paradigm shift” in the treatment of sepsis.

“Our experience has been echoed by now hundreds, if not thousands, of clinicians across the world,” said Dr. Marik, chief of the division of pulmonary and critical care medicine, Eastern Virginia Medical School, Norfolk.

He recounted an anecdotal case submitted by “Josh from Ohio” describing an elderly man who was “started on cocktail and within a day his pressor requirements melted away and he was extubated.” Quoting “Josh from Ohio,” Dr. Mark continued, “Tomorrow he will probably leave the ICU with no residual organ dysfunction, no volume overload, (and) no ICU complications.”

Eddy Gutierrez, MD, of Jacksonville, Fla., noted in a question-and-answer period that he has had “positive results” with a similar approach.

“When we first learned about the vitamin C and the ‘Marik protocol,’ so to speak, I was in fellowship and I got laughed at,” Dr. Gutierrez said. “Nobody would let me try it.”

Others are taking a wait-and-see approach.

Greg S. Martin, MD, secretary of the Society of Critical Care Medicine, said in an interview that there are “at least two schools of thought” among critical care specialists regarding the use of hydrocortisone, vitamin C, and thiamine for treatment of sepsis and septic shock.

“One school of thought is that this is incredibly important if this is even fractionally as effective as what [Dr. Marik] showed, because we have not found an effective therapy for sepsis,” said Dr. Martin, associate professor of medicine at Grady Memorial Hospital, Atlanta.

“The contrarian approach is to say, ‘yes, but this seems remarkably unlikely to be as effective as what he has shown,’ ” Dr. Martin added. “Particularly in sepsis, people are very skeptical of whether a drug or a drug combination is going to be as effective when you really get down to a high-quality randomized controlled trial that would be the definitive level of evidence.”

The wait may not be long for at least some data. Multiple clinical trials are recruiting or planned, according to Dr. Marik. These included a 140-patient U.S. randomized, double-blind trial of vitamin C, hydrocortisone, and thiamine vs. placebo that started in February 2018 and is expected to be completed by February 2019, according to the study’s listing.

“The good news is some people think this is of value,” Dr. Marik said.

As part of his presentation, Dr. Marik reported a disclosure related to Baxter (advisory board).


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