"Ethically and morally unacceptable": Reaction to vitamin C for sepsis trial

By Nikki Hancocks

- Last updated on GMT

Getty | JJSINA
Getty | JJSINA

Related tags Vitamin c sepsis

A recent study claiming to disprove the 'Marik protocol' as an effective treatment for sepsis has been slammed by Professor Marik who says the study was rendered void by the futile administration of his protocol.

The recent VITAMINS study​ involving 211 patients across ten intensive care units in Australia, New Zealand and Brazil claimed to quash a widely held belief which originated when Professor Paul Marik, from the Eastern Virginia Medical School, used intravenous Vitamin C with thiamine and steroids to treat patients with sepsis in his intensive care unit. 

The treatment, now known as the 'Marik protocol', has been adopted by units worldwide but the VITAMINS study led by Professor Rinaldo Bellomo, from Monash University, published in the Journal of the American Medical Association​, claims to provide evidence that the vitamin c cocktail is not superior to usual care with hydrocortisone alone.

But Marik, who notes that this has become a "highly polarised and emotionally charged" issue, has hit back at the study saying Marik's protocol clearly states that quick treatment is essential for the method to work as septic shock is a highly time dependent disease, advising no more than six hours between admission and first treatment, and a wait of over 18 hours meaning death. 

He says VITAMINS' authors provide no data on time between admission and treatment but he says what we do know is the time between admission and randomisation was a mean of about 12 hours and time between randomisation and first treatment was a mean of 14.9 hours again.

Speaking at a recent Critical Care Reviews Meeting in Belfast, Marik stated: "I contend that doing a study that is designed to fail is ethically and morally unacceptable."

In a statement for NutraIngredients, he added: "I am very disappointed and saddened by the results of the VITAMINS study. There is no question in my mind that this intervention saves lives. This has been the experience of hundreds of clinicians around the world, who have used this intervention early in the course of severe sepsis and septic shock when combined with high quality supportive care.

"Despite the fact that VITAMINS had an IRB approved delayed consent provision, it appears to have taken an inordinate time from hospital admission until the first dose of vitamin C was administered. VITAMINS therefore does not replicate real word experience. 

"In addition, it is important to recognise that sepsis is not a disease but a syndrome that includes a heterogenous group of patients with various diagnoses. It would appear that there was marked heterogeneity of patients in the VITAMINS study; this would dilute out any clinical benefit.

"Furthermore, the approach to fluid resuscitation is a critical factor in the management of septic shock as fluid overload will diminish the clinical benefit of this therapy. No fluid data was presented in the VITAMINS publication.

"I am fearful that future studies that ignore these critical issues will likewise fail to demonstrate a benefit from HAT (Hydrocortisone, Ascorbic Acid and Thiamine) therapy." 

He also notes that a recent study into HAT therapy, published in the Blue journal,​ demonstrated a marked survival benefit in children with septic shock​ - roughly a 70% reduction in mortality. Whilst this was only a retrospective study, 43 control, 43 with the new protocol, the researchers did follow the Marik protocol more closely.  

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