Study sets the record straight on unproven therapy to treat sepsis

The Jan. 17 issue of the Journal of the American Medical Association (JAMA) features an important study about sepsis with an accompanying editorial by a University of Nebraska Medical Center expert. The study and editorial sets the record straight on an unproven therapy some physicians use to treat sepsis, a deadly infectious disease.

The editorial, written by Andre Kalil, M.D., M.P.H., professor of infectious diseases in the UNMC Department of Internal Medicine, writes in support of the new and rigorous international study based on a randomized clinical trial in Australia, published in the same issue. The editorial appears in the Jan. 17 online issue and also will appear in the Feb. 4 print edition.

The study has major implications for patients with sepsis and the medical community.

The combination of high-dose vitamin C, thiamine and hydrocortisone has been suggested to provide benefits based on a small single-center retrospective observational study. Even though not tested in more rigorous studies, such as randomized controlled trials, and not approved for clinical practice, many doctors have been using this therapy.

Until now, no rigorous clinical trial had been done. This new randomized trial does not confirm previous beliefs about the high-dose vitamin C, thiamine, and hydrocortisone purported benefit, and there are potential safety issues for both patients and society associated with the continuation of its use without providing survival benefits."

Dr. Andre Kalil, professor of infectious diseases in the UNMC Department of Internal Medicine

Sepsis is the body's dysregulated response to infection that can lead to organ damage and death. Dr. Kalil said even with the best standard of care, 20-30% of patients die from sepsis.

The recently completed trial involved 216 patients in Australia, New Zealand and Brazil. The intervention group received intravenous vitamin C, hydrocortisone and thiamine plus usual care, and a control group received intravenous hydrocortisone plus usual care.

The study suggests that treatment with intravenous vitamin C, hydrocortisone, and thiamine does not lead to a more rapid resolution of septic shock and does not decrease mortality compared with controls.

Dr. Kalil was invited to write the editorial because of his recognized expertise in the field and the high relevance of the study.