Conventional thought process under scrutiny

Good morning.
         Several interesting studies have been presented at the ESICM meeting in Paris. Some of these have simultaneously been published online.
         One such study, attempted to evaluate the risk benefit aspects of stress ulcer prophylaxis (SUP) among critically ill patients. Although SUP is extensively prescribed and is considered as a quality marker for ICU care, concerns have been raised of late about the increased incidence of nosocomial pneumonia and diarrhea attributable to SUP. This study aimed to answer some of those concerns

Krag et al: Pantoprazole in Patients at Risk for Gastrointestinal Bleeding in the ICU. NEJM Oct 24 2018

This was a multi center, blinded RCT carried out in Europe. The authors hypothesized that SUP with Pantoprazole would decrease the incidence of Gastro Intestinal Bleeding while increasing the incidence of nosocomial infections and Myocardial Ischemia.
                 The patients included in this study had to have atleast one risk factor for clinically important GI bleeding among shock, oral anticoagulant usage, renal replacement therapy, need for mechanical ventilation > 24 hours, history of liver disease or ongoing coagulopathy. Pantoprazole was used as SUP as an intravenous injection of 40 mg diluted in 10ml of 0.9% saline. A matching placebo was used.
               The primary end point of interest was 90 day mortality. Secondary end points included clinically important gastrointestinal bleeding, new-onset pneumonia, C. difficile infection, or acute myocardial ischemia. Need for RRT and Mechanical ventilation were also included as end points.
            This study was carried out between January 2016 and October 2017, enrolling 3298 patients ( 1645 - pantoprazole 1653 placebo). More than 3/4ths of the patients needed mechanical ventilation and more than 2/3rds required vasopressor support. Median SOFA scores of the cohort was 9. More than half the patients received enteral nutrition on the first day of the trial. Average LOS was 6 days and duration of therapy was 4 days.
               At the end of 90 days, approximately 30% of patients in both arms had died. There was no difference between the Pantoprazole and the placebo groups. Clinically important events like gi bleed, infection or myocardial ischemia happened in 21-22% of the patients in both the groups. Specifically, GI bleed occurred in 2.8% of patients receiving pantoprazole and 4.2% patients receiving placebo. This difference was statistically insignificant. There were no serious adverse incidents in either group.
             The authors concluded that " 90-day mortality, percentages of days alive without the use of life support, and numbers of patients with clinically important events, infectious adverse events, or serious adverse reactions were similar between those treated with pantoprazole and those who received placebo".  At the same time incidence of myocardial ischemia and nosocomial infections were not higher in the pantoprazole group.

My opinion: A serious rethinking has to happen regarding the  " routine" use of SUP with Pantoprazole. Although the concerns of harm have been partially allayed, the basis for blanket use for all comers is also under question. If enteral feed can be started on the first day, addition of pantoprazole may not confer any additional benefit.