Standard care supplemented with nanoselenium versus standard care alone for sepsis: a randomized clinical trial
Sepsis
Eligible patients will be randomly assigned in a 1:1 ratio to receive either the standard care supplemented with nanoselenium or standard care alone. The random allocation sequence will be generated by an independent statistician using computer software, with random block sizes of 4 and 6. To conceal the allocation, the assignments will be placed in sequentially numbered, opaque, sealed envelopes. The envelopes will be kept securely and opened only by the study coordinator after a participant is formally enrolled. To ensure blinding, the researchers administering the interventions, the patients and their families, the outcome assessors, and the data statisticians will all be kept unaware of the group assignments throughout the trial. Control group: receives standard management, following the 2021 international guidelines for sepsis and septic shock, supplemented with local clinical practice. Standard treatments included early administration of appropriate antibiotics, hemodynamic stabilization with fluid resuscitation and vasopressors, invasive or non-invasive mechanical ventilation when indicated, and extracorporeal organ support such as renal replacement therapy. Intervention group: receives standard care supplemented with nanoselenium (total dose: 400 μg) once daily at 8:00 AM for up to 10 days, unless discontinued earlier due to ICU discharge, death, or withdrawal. Nanoselenium was administered either orally or diluted in 0.9% sodium chloride via nasogastric or nasointestinal tube. The product was manufactured by Guangdong Jinan Established Selenium Source Nano Technology Research Institute Co., Ltd., China.
1. Age ≥ 18 years 2. Meet the criteria for sepsis according to the Sepsis-3 definition 3. Expected ICU length of stay > 48 hours 4. Written informed consent obtained from the patient or their legally authorized representative
1. Pregnant or breastfeeding women 2. Current use of selenium supplements or known allergy or intolerance to selenium preparations 3. Chronic renal insufficiency requiring regular dialysis 4. Severe hepatic insufficiency (Child-Pugh class C) or acute liver failure 5. Next of kin expressing a wish to withdraw life-sustaining treatment or initiate hospice care 6. Expected survival <3 days 7. Active hematologic malignancy 8. History of organ or bone marrow transplantation 9. History of cardiopulmonary resuscitation (CPR) within 72 hours prior to signing informed consent 10. Inability to obtain informed consent from a legally authorized representative, or explicit refusal to sign informed consent