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Nano-selenium in combination with Xuebijing injection in patients with sepsis: a randomized controlled trial

Nano-selenium in combination with Xuebijing injection in patients with sepsis: a randomized controlled trial (inflammatory biomarkers, immune function, oxidative stress indices, and clinical outcomes)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072222
Enrollment
Unknown
Registered
2023-06-07
Start date
2023-07-01
Completion date
Unknown
Last updated
2023-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

Interventions

Nano-selenium in combination with Xuebijing injectionon:On the basis of Xuebijing treatment, 4 nano-selenium capsules (100ug selenium/capsule) were fed with nasogastric tube once a day for 7 days or u
Xuebijing injectionon:100ml Xubijing injection plus 0.9% sodium chloride injection 100ml was given intravenously for 7 days or until the patient was discharged from ICU or died.

Sponsors

The First Affiliated Hospital of Jinan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Patients aged 18 to 80 years, both males and females; 2) Patients with Sepsis defined as Sepsis 3.0 admitted to ICU; 3) Patients expected to stay in ICU for more than 48 hours; 4) Patients receiving enteral nutrition.

Exclusion criteria

Exclusion criteria: 1) Pregnant women; 2) Patients known to be allergic to Xuebijing and selenium supplements; 3) Patients with malignant tumor receiving radiotherapy and chemotherapy; 4) Patients with chronic renal insufficiency requiring dialysis (GFR < 60 ml/min/1.73m2); 5) Chronic severe liver insufficiency (Child-Pugh grade C); 6) Patients receiving blood purification treatment; 7) Patients on immunosuppressive drugs or those who have received an organ transplant within the last six months; 8) Intolerance to enteral nutrition, intestinal ischemia-necrosis obstruction, pancreatitis, short bowel syndrome, etc.

Design outcomes

Primary

MeasureTime frame
Inflammatory biomarkers, including TNF-a?IL-1ß?IL-6?IL-10;Immune function, including Th1/Th2?CD4+ T?CD8+ T?mHLA-DR;Oxidative stress indices, including GPX-3?SOD?MDA;

Secondary

MeasureTime frame
Selenium levels and selenoprotein;Clinical outcomes, including ICU mortality, in-hospital mortality, length of ICU stay, length of hospital stay, SOFA score;

Countries

China

Contacts

Public ContactHai-Yan Yin

The First Affiliated Hospital of Jinan University

haiyanyin1867@126.com+86 133 1883 1222

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026