CHEST Guidelines-Response_chest

Response_chest_19 (1)

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The document addresses a response to concerns raised about a study involving the treatment of severe sepsis and septic shock using a combination of hydrocortisone, vitamin C, and thiamine. Ian C. Michelow and colleagues initially expressed concerns regarding the ethical oversight of the study due to the uncertain risks, benefits, and effectiveness of this treatment combination, suggesting that Institutional Review Board (IRB) oversight was necessary to uphold ethical standards in clinical research.<br /><br />The response from Paul E. Marik and colleagues clarifies that their study was indeed approved by their IRB, with protocol details provided in an e-Appendix. They highlight the established use of low-dose corticosteroids in severe sepsis and the acute vitamin C deficiency inconsistently observed in such patients. They reiterate that the treatment dosage was aligned with the recommendations for vitamin C deficiency outlined in the package insert. Numerous studies are cited to testify to the safety and prior successful use of intravenous vitamin C in severe infections and critical care scenarios, including surgical care, traumatic injuries, and other conditions.<br /><br />Marik and colleagues argue that withholding a safe, inexpensive, and potentially life-saving treatment in urgent sepsis scenarios could be considered unethical. They emphasize the high mortality associated with severe sepsis, lack of effective alternative treatments, and the physician's duty to mitigate life-threatening outcomes. However, to validate the effectiveness of this treatment combination, they acknowledge the need for further randomized controlled trials, which are being planned.<br /><br />The document underlines a commitment to the ethical principles of beneficence, nonmaleficence, and social justice in healthcare, while ensuring future research confirms the observed benefits.

Keywords

severe sepsis

septic shock

hydrocortisone

vitamin C

thiamine

ethical oversight

Institutional Review Board

clinical research

randomized controlled trials

treatment effectiveness