Mecobalamin Combined With Ceftriaxone Sodium in the Treatment of Sepsis Liver Injury

Launched by SICHUAN PROVINCIAL PEOPLE'S HOSPITAL · Jan 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients suffering from sepsis, a serious condition caused by infections that can lead to liver damage and other complications. Researchers are exploring the effects of combining two medications, mecobalamin and ceftriaxone sodium, to see if they can help protect the liver and improve outcomes for patients with mild to moderate sepsis. The trial aims to better understand how these medications can stop harmful processes in the body that contribute to liver failure during sepsis.

To participate in this study, patients must be between the ages of 18 and 85 and have been admitted to the ICU within the last 24 hours with signs of sepsis. They should also have specific levels of bile acids and bilirubin in their blood, indicating liver dysfunction. Participants will be randomly assigned to receive either the new treatment combination or a placebo, while all patients will continue to receive standard care for sepsis. Throughout the trial, participants can expect regular monitoring and support from healthcare professionals. This study aims to find a more effective way to treat sepsis-related liver injury, which could lead to better recovery for patients in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Mild to moderate sepsis as defined by the △SOFA score;
• • 2. Admission to ICU \<24 hours;
• • 3. Serum total bile acid concentration TBA ≥10μmol/L, total bilirubin concentration TBiL ≥17.1 μmol/L;
• • 4. Patients with suspected or confirmed infection as the main cause.-
• Exclusion Criteria:
• • 1. Age \>85 years or \<18 years;
• • 2. Patients contraindicated for mecobalamin treatment, allergic to ceftriaxone sodium, or other contraindications;
• • 3. Existence of a potential disease with a life expectancy of \<1 year;
• • 4. Patients with non-infectious causes such as burns, trauma, chemical poisoning;
• • 5. Withdrawal of life support or anticipated life-threatening condition within 48 hours;
• • 6. History of autoimmune diseases, tumors, hepatobiliary diseases, diabetes, metabolic genetic diseases;
• • 7. Vitamin B deficiency, malnutrition history;
• • 8. Re-admission to ICU within one year;
• • 9. Relatives or guardians unwilling to participate in the study;
• • 10. Pregnancy.-