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The Effect of the Combination of Mecobalamin and Ceftriaxone Sodium on Liver Injury in Sepsis and Clinical Prognosis Observation

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What is being tested

Mecobalamin

+ Ceftriaxone Sodium

+ Saline

Drug
Who is being recruted

Digestive System Diseases+5

+ Infections

+ Inflammation

From 18 to 85 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 4
Interventional
Study Start: January 2024
See protocol details

Summary

Principal SponsorSichuan Provincial People's Hospital
Study ContactSen Lu
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 15, 2024

Actual date on which the first participant was enrolled.

This study aims to explore how a combination of two drugs, mecobalamin and ceftriaxone sodium, impacts liver damage in patients with sepsis, a severe response to infection. The trial focuses on patients with mild to moderate sepsis who have been admitted to the Intensive Care Unit (ICU) within the last 24 hours. These patients show elevated levels of certain liver-related chemicals, indicating potential liver injury. The study seeks to improve the clinical outcomes and liver function of these patients, potentially leading to better overall recovery and reduced complications from sepsis. In this study, participants are randomly divided into two groups. One group receives standard sepsis care along with a placebo, while the other group receives standard care plus an intravenous drip of ceftriaxone sodium and mecobalamin injections. The treatment with these drugs continues for 14 days, followed by oral mecobalamin tablets for another 14 days. Researchers monitor various health indicators, such as liver function, organ failure, and overall survival, on specific days during and after the treatment. The primary goal is to observe whether the liver function improves by the end of the study, while also tracking secondary outcomes like mortality rate and hospital stay duration.

Official TitleThe Effect of the Combination of Mecobalamin and Ceftriaxone Sodium on Liver Injury in Sepsis and Clinical Prognosis Observation
NCT06220929
Principal SponsorSichuan Provincial People's Hospital
Study ContactSen Lu
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesInfectionsInflammationLiver DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSystemic Inflammatory Response SyndromeSepsis

Criteria

4 inclusion criteria required to participate
Mild to moderate sepsis as defined by the △SOFA score;
Admission to ICU <24 hours;
Serum total bile acid concentration TBA ≥10μmol/L, total bilirubin concentration TBiL ≥17.1 μmol/L;
Patients with suspected or confirmed infection as the main cause.-
10 exclusion criteria prevent from participating
Age >85 years or <18 years;
Patients contraindicated for mecobalamin treatment, allergic to ceftriaxone sodium, or other contraindications;
Existence of a potential disease with a life expectancy of <1 year;
Patients with non-infectious causes such as burns, trauma, chemical poisoning;
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Patients were randomly divided into intervention and control groups, with both groups receiving standard treatment and care for sepsis (decided by the attending physician). On this basis, the following treatments were administered: Intervention group (n=20): intravenous drip of ceftriaxone sodium 1g per dose, twice daily (continuously for 14 days), mecobalamin injection 1mg per dose, once daily (on days 1, 2, 3, 5, 7, 9, 11, 13), with a half-hour interval between medications. From day 15 to 28, take mecobalamin tablets orally, 1mg per dose, three times a day.

Group II

Sham
Patients were randomly divided into intervention and control groups, with both groups receiving standard treatment and care for sepsis (decided by the attending physician). On this basis, the following treatments were administered: Control group (n=20): intravenous saline drip/oral placebo tablets.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Sichuan Provincial People's Hospital

Chengdu, ChinaOpen Sichuan Provincial People's Hospital in Google Maps
Recruiting soonOne Study Center