Nanoselenium as adjunctive therapy for patients with sepsis
| ISRCTN | ISRCTN10478464 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10478464 |
| Sponsor | First Affiliated Hospital of Jinan University |
| Funder | First Affiliated Hospital of Jinan University |
- Submission date
- 03/05/2026
- Registration date
- 05/05/2026
- Last edited
- 05/05/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Sepsis is a life-threatening organ dysfunction caused by infection, with high incidence and death rates, posing a significant global public health burden. Current treatments primarily rely on anti-inflammatory therapy and organ support, yet death rates remain high. Immunomodulation may emerge as a new therapeutic direction. Our previous pilot trial found that nanoselenium supplementation enhances immune function, attenuates excessive inflammation, and protects against multiple organ dysfunction with a favorable safety profile in patients with sepsis. The present study aims to evaluate the effectiveness and safety of nanoselenium in critically ill patients with sepsis, with a particular focus on its effects on death rates, immune function, inflammatory markers, organ function, selenium levels, other relevant indicators, and safety outcomes.
Who can participate?
Sepsis patients aged 18 years and over admitted to the ICU
What does the study involve?
Participants are randomly assigned into two groups. The control group receives standard management supplemented with local clinical practice. The intervention group receives standard care supplemented with nanoselenium once daily for up to 10 days, unless discontinued earlier due to ICU discharge, death, or withdrawal, administered either orally or by feeding tube.
What are the possible benefits and risks of participating?
Participants will receive standard sepsis treatment and close monitoring. The intervention treatment may help improve immune function and patient condition, although this effect is still under investigation.
Adverse reactions related to the study drugs (nanoselenium) may occur, such as allergic reactions or abnormal liver function. The study will strictly monitor any adverse events and has a detailed risk management plan in place to ensure participant safety.
Where is the study run from?
The First Affiliated Hospital of Jinan University (China)
When is the study starting and how long is it expected to run for?
May 2026 to December 2028
Who is funding the study?
The First Affiliated Hospital of Jinan University (China)
Who is the main contact?
Dr Wan-Jie Gu, guwanjie@jnu.edu.cn
Contact information
Principal investigator, Public, Scientific
613 Huangpu Avenue West
Guangzhou
510630
China
 ORCID ID |
0000-0003-4923-8282 |
|---|---|
| Phone | +86 (0)15850546835 |
| guwanjie@jnu.edu.cn |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Active |
| Assignment | Parallel |
| Purpose | Supportive care, Treatment |
| Scientific title | Standard care supplemented with nanoselenium versus standard care alone for sepsis: a randomized clinical trial |
| Study objectives | The present study aims to evaluate the efficacy and safety of nanoselenium in critically ill patients with sepsis, with a particular focus on its effects on mortality, immune function, inflammatory markers, organ function, selenium levels, other relevant indicators, and safety outcomes. |
| Ethics approval(s) |
Approved 22/04/2026, Scientific Research Ethics Committee of the First Affiliated Hospital of Jinan University (613 Huangpu Avenue West, Guangzhou, 510630, China; +86 (0)20-38688077; haiyanyin1867@126.com), ref: KY-2026-141 |
| Health condition(s) or problem(s) studied | Sepsis |
| Intervention | 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. |
| Intervention type | Supplement |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 31/12/2028 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 516 |
| Key inclusion criteria | 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 |
| Key exclusion criteria | 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 |
| Date of first enrolment | 01/05/2026 |
| Date of final enrolment | 01/12/2028 |
Locations
Countries of recruitment
- China
Study participating centres
Guangzhou
510630
China
Guangzhou
510220
China
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
05/05/2026: Study's existence confirmed by the Scientific Research Ethics Committee of the First Affiliated Hospital of Jinan University.
