SepsisPhase 4NCT06220929
Mecobalamin Combined With Ceftriaxone Sodium in the Treatment of Sepsis Liver Injury
A Phase 4 study testing Mecobalamin, Ceftriaxone Sodium and Saline in people with Sepsis and Liver Dysfunction, run by Sichuan Provincial People's Hospital at 1 site in China.
Trial summary
The previous research of our research group shows that during the course of sepsis, the pyroptosis mediated by the caspase-4/GSDMD pathway in immune cells, induced by pathogens, is the main cause of immune collapse in sepsis patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Sepsis, Liver Dysfunction
- What is being tested?
- Mecobalamin, Ceftriaxone Sodium and Saline
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2024to 1 Jan 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.-
Who cannot join
- 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;
- Withdrawal of life support or anticipated life-threatening condition within 48 hours;
- History of autoimmune diseases, tumors, hepatobiliary diseases, diabetes, metabolic genetic diseases;
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- Vitamin B deficiency, malnutrition history;
- Re-admission to ICU within one year;
- Relatives or guardians unwilling to participate in the study;
- Pregnancy.-
Trial locations and contacts
1 site in 1 country.
China1 site
Sichuan Provincial People's Hospital
Chengdu, Sichuan
Chun Pan, 13814009925, panchun1982@gmail.com
About this study
Official title: The Effect of the Combination of Mecobalamin and Ceftriaxone Sodium on Liver Injury in Sepsis and Clinical Prognosis Observation
The previous research of our research group shows that during the course of sepsis, the pyroptosis mediated by the caspase-4/GSDMD pathway in immune cells, induced by pathogens, is the main cause of immune collapse in sepsis patients. The preliminary study of this project further reveals that sepsis combined with intrahepatic cholestasis subsequently induces a rapid hepatocyte pyroptosis mediated by the Apaf-1 pyroptosome/caspase-3/GSDME signaling pathway. The interaction of these two processes triggers liver organ failure, suggesting GSDMD/GSDME as targets for the treatment of liver damage/liver failure in sepsis . Based on high-throughput drug screening and validation in in vivo and in vitro models, it was found that the combination of the old drug mecobalamin with ceftriaxone sodium, or with thiamine, used therapeutically, can block both of these cell pyroptosis pathways. Compared with corticosteroid drugs like dexamethasone and liver-protecting drugs, they have superior effects. 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; 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.
Read the detailed description
- Eligibility 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.
- Withdrawal Criteria (1) Adverse reactions related to mecobalamin or ceftriaxone sodium treatment; (2) Rapid progression of disease requiring treatment adjustment; (3) Other life-threatening reasons as decided by the clinician to stop the trial; (4) Patient or guardian request to withdraw from the trial.
- Termination Criteria (1) Severe or intolerable adverse events (e.g., severe liver and kidney dysfunction), necessitating withdrawal from the trial as judged by the researchers; (2) Decision by the patient and family to withdraw from the study at any stage; (3) Discontinuation of participation in the study as deemed necessary by the attending physician based on the patient's condition.
- Study Content 5.1 Screening Period Within 24 hours before enrollment, perform blood routine, liver and kidney function tests, and interviews. Select sputum, blood, and other fluid samples based on potential infection sites for smear and Gram staining microscopy. Concurrently conduct blood culture and drug sensitivity tests to assess the most likely pathogens causing infection. Randomly assign patients into either the placebo group or the ceftriaxone group following the principle of random controlled trials, done by a computer system (like drawing lots) at a 1:1 ratio. The process is uncontrollable by doctors or others. All trial drug packages look the same and can only be identified by a unique trial identifier. Group assignment and drug numbering are managed by a designated person. The appearance of the drug boxes for both groups is identical, and the attending physicians and patients are unaware of whether the drugs in the numbered boxes are placebo or therapeutic. The bedside nurses are responsible for administering the numbered drugs according to the plan, thus ensuring blinding of the trial participants and all research center staff to ceftriaxone, mecobalamin, or placebo. 5.2 Intervention Period Both groups receive standard sepsis treatment and care (decided by the attending physician). Additional treatments are as follows: 1) Control group (n=20): intravenous saline drip/oral placebo tablets; 2) Mecobalamin + ceftriaxone sodium group (n=20): intravenous drip of ceftriaxone sodium 1g per dose, twice daily (for 14 consecutive days), and mecobalamin injection 1mg per dose, once daily (on days 1, 2, 3, 5, 7, 9, 11, 13), with at least a half-hour interval between medications. From day 15 to 28, take mecobalamin tablets orally, 1mg per dose, three times a day. 5.3 Follow-up Period 5.3.1 Main Indicators (1) General data: Admission basic materials (name, gender, date of birth, height, actual weight, etc.), ICU admission details (time of joining the group, APACHEII score, SOFA score, Glasgow score, main diagnosis, medical history, etc.), pre-enrollment treatment and medication records. (2) On days 1, 3, 7, 14, and 28 or before transfer from ICU: organ failure (SOFA score), ALT, AST, total bilirubin, direct bilirubin, indirect bilirubin, bile acids, blood ammonia, coagulation function, blood gases, vasoactive drugs, kidney function, serum lactate. (3) Liver ultrasound imaging on days 1, 7, 14, or before ICU transfer. Note: Organ failure is measured by the Sequential Organ Failure Assessment (SOFA) score, grading the function of six organ systems based on blood pressure and vasoactive drug needs, oxygenation, platelet count, serum creatinine, and bilirubin levels, as well as the Glasgow Coma Scale score. The severity of illness is measured by the Acute Physiology and Chronic Health Evaluation (APACHE) II, ranging from 0 to 71, with higher scores indicating a higher risk of death.
- Evaluation Indicators/Study Endpoints 6.1 Primary Observation Endpoint Improvement in liver function by 28 days or at discharge/death: Total bilirubin reduced to ≤17.1μmol/L and bile acids <10μmol/L. 6.2 Secondary Observation Endpoints (1) 28-day mortality rate; (2) ICU and hospital stay duration; (3) Number of days without organ dysfunction in 28 days; (4) Changes in serum markers related to cell pyroptosis and tissue necrosis, such as interleukins-1β, 1α, LDH, etc.
- Visit Arrangement and Data Collection During the Study (1) General data: Admission basic materials (name, gender, date of birth, height, actual weight, etc.), ICU admission details (time of joining the group, APACHEII score, SOFA score, Glasgow score, main diagnosis, medical history, etc.), pre-enrollment treatment and medication records. (2) On days 1, 3, 7, 14, and 28 or before transfer from ICU: organ failure (SOFA score), ALT, AST, total bilirubin, direct bilirubin, indirect bilirubin, bile acids, blood ammonia, coagulation function, blood gases, vasoactive drugs, kidney function, serum lactate. (3) Liver ultrasound imaging on days 1, 7, 14, or before ICU transfer.
- Conditions
- Sepsis, Liver Dysfunction
- Being tested
- Mecobalamin, Ceftriaxone Sodium, Saline, Placebo
- Medical subject headings
- Sepsis, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MecobalaminDrug
The drug Mecobalamin in the intervention group was divided into intravenous and oral formulations, with the intravenous formulation being used for the first 14 days of the experiment and the oral formulation for the second 14 days.
Ceftriaxone SodiumDrug
Ceftriaxone sodium all intravenous formulations
SalineDrug
The saline used in the control group was the same as the saline used in the experimental group to dispense the drug
PlaceboDrug
Placebo and Mecobalamin tablets look and smell the same.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Sham comparator | 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. Receives: Drug: Saline; Drug: Placebo |
| Intervention group | 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. Receives: Drug: Mecobalamin; Drug: Ceftriaxone Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
total bilirubin
Total bilirubin reduced to 17.1 μmol/L
Measured: 28 days or when patient is discharged/dead
bile acids
Bile acids <10 μmol/L
Measured: 28 days or when patient is discharged/dead
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start15 Jan 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun Pan, Sichuan Provincial People's Hospital
- Investigators
- Chun Pan, ph.D, Study director, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06220929
- Sponsor's protocol ID
- CPan
- Status last verified
- Jan 2024
- First submitted
- 13 Jan 2024
- Last updated
- 24 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lelubre C, Vincent JL. Mechanisms and treatment of organ failure in sepsis. Nat Rev Nephrol. 2018 Jul;14(7):417-427. doi: 10.1038/s41581-018-0005-7.
PubMed 29691495He XL, Chen JY, Feng YL, Song P, Wong YK, Xie LL, Wang C, Zhang Q, Bai YM, Gao P, Luo P, Liu Q, Liao FL, Li ZJ, Jiang Y, Wang JG. Single-cell RNA sequencing deciphers the mechanism of sepsis-induced liver injury and the therapeutic effects of artesunate. Acta Pharmacol Sin. 2023 Sep;44(9):1801-1814. doi: 10.1038/s41401-023-01065-y. Epub 2023 Apr 11.
PubMed 37041228Jiao C, Zhang H, Li H, Fu X, Lin Y, Cao C, Liu S, Liu Y, Li P. Caspase-3/GSDME mediated pyroptosis: A potential pathway for sepsis. Int Immunopharmacol. 2023 Nov;124(Pt B):111022. doi: 10.1016/j.intimp.2023.111022. Epub 2023 Oct 12.
PubMed 37837715Pan C, Chen L, Lu C, Zhang W, Xia JA, Sklar MC, Du B, Brochard L, Qiu H. Lung Recruitability in COVID-19-associated Acute Respiratory Distress Syndrome: A Single-Center Observational Study. Am J Respir Crit Care Med. 2020 May 15;201(10):1294-1297. doi: 10.1164/rccm.202003-0527LE. No abstract available.
PubMed 32200645
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Combination of Mecobalamin and Ceftriaxone Sodium on Liver Injury in Sepsis and Clinical Prognosis Observation
- ClinicalTrials.gov ID
- NCT06220929
- Acronym / sponsor ID
- CPan
- Conditions
- Sepsis, Liver Dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Study start
- 15 Jan 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 24 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The previous research of our research group shows that during the course of sepsis, the pyroptosis mediated by the caspase-4/GSDMD pathway in immune cells, induced by pathogens, is the main cause of immune collapse in sepsis patients. The preliminary study of this project further reveals that sepsis combined with intrahepatic cholestasis subsequently induces a rapid hepatocyte pyroptosis mediated by the Apaf-1 pyroptosome/caspase-3/GSDME signaling pathway. The interaction of these two processes triggers liver organ failure, suggesting GSDMD/GSDME as targets for the treatment of liver damage/liver failure in sepsis . Based on high-throughput drug screening and validation in in vivo and in vitro models, it was found that the combination of the old drug mecobalamin with ceftriaxone sodium, or with thiamine, used therapeutically, can block both of these cell pyroptosis pathways. Compared with corticosteroid drugs like dexamethasone and liver-protecting drugs, they have superior effects. 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; 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.
Detailed description
- Eligibility 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.
- Withdrawal Criteria (1) Adverse reactions related to mecobalamin or ceftriaxone sodium treatment; (2) Rapid progression of disease requiring treatment adjustment; (3) Other life-threatening reasons as decided by the clinician to stop the trial; (4) Patient or guardian request to withdraw from the trial.
- Termination Criteria (1) Severe or intolerable adverse events (e.g., severe liver and kidney dysfunction), necessitating withdrawal from the trial as judged by the researchers; (2) Decision by the patient and family to withdraw from the study at any stage; (3) Discontinuation of participation in the study as deemed necessary by the attending physician based on the patient's condition.
- Study Content 5.1 Screening Period Within 24 hours before enrollment, perform blood routine, liver and kidney function tests, and interviews. Select sputum, blood, and other fluid samples based on potential infection sites for smear and Gram staining microscopy. Concurrently conduct blood culture and drug sensitivity tests to assess the most likely pathogens causing infection. Randomly assign patients into either the placebo group or the ceftriaxone group following the principle of random controlled trials, done by a computer system (like drawing lots) at a 1:1 ratio. The process is uncontrollable by doctors or others. All trial drug packages look the same and can only be identified by a unique trial identifier. Group assignment and drug numbering are managed by a designated person. The appearance of the drug boxes for both groups is identical, and the attending physicians and patients are unaware of whether the drugs in the numbered boxes are placebo or therapeutic. The bedside nurses are responsible for administering the numbered drugs according to the plan, thus ensuring blinding of the trial participants and all research center staff to ceftriaxone, mecobalamin, or placebo. 5.2 Intervention Period Both groups receive standard sepsis treatment and care (decided by the attending physician). Additional treatments are as follows: 1) Control group (n=20): intravenous saline drip/oral placebo tablets; 2) Mecobalamin + ceftriaxone sodium group (n=20): intravenous drip of ceftriaxone sodium 1g per dose, twice daily (for 14 consecutive days), and mecobalamin injection 1mg per dose, once daily (on days 1, 2, 3, 5, 7, 9, 11, 13), with at least a half-hour interval between medications. From day 15 to 28, take mecobalamin tablets orally, 1mg per dose, three times a day. 5.3 Follow-up Period 5.3.1 Main Indicators (1) General data: Admission basic materials (name, gender, date of birth, height, actual weight, etc.), ICU admission details (time of joining the group, APACHEII score, SOFA score, Glasgow score, main diagnosis, medical history, etc.), pre-enrollment treatment and medication records. (2) On days 1, 3, 7, 14, and 28 or before transfer from ICU: organ failure (SOFA score), ALT, AST, total bilirubin, direct bilirubin, indirect bilirubin, bile acids, blood ammonia, coagulation function, blood gases, vasoactive drugs, kidney function, serum lactate. (3) Liver ultrasound imaging on days 1, 7, 14, or before ICU transfer. Note: Organ failure is measured by the Sequential Organ Failure Assessment (SOFA) score, grading the function of six organ systems based on blood pressure and vasoactive drug needs, oxygenation, platelet count, serum creatinine, and bilirubin levels, as well as the Glasgow Coma Scale score. The severity of illness is measured by the Acute Physiology and Chronic Health Evaluation (APACHE) II, ranging from 0 to 71, with higher scores indicating a higher risk of death.
- Evaluation Indicators/Study Endpoints 6.1 Primary Observation Endpoint Improvement in liver function by 28 days or at discharge/death: Total bilirubin reduced to ≤17.1μmol/L and bile acids <10μmol/L. 6.2 Secondary Observation Endpoints (1) 28-day mortality rate; (2) ICU and hospital stay duration; (3) Number of days without organ dysfunction in 28 days; (4) Changes in serum markers related to cell pyroptosis and tissue necrosis, such as interleukins-1β, 1α, LDH, etc.
- Visit Arrangement and Data Collection During the Study (1) General data: Admission basic materials (name, gender, date of birth, height, actual weight, etc.), ICU admission details (time of joining the group, APACHEII score, SOFA score, Glasgow score, main diagnosis, medical history, etc.), pre-enrollment treatment and medication records. (2) On days 1, 3, 7, 14, and 28 or before transfer from ICU: organ failure (SOFA score), ALT, AST, total bilirubin, direct bilirubin, indirect bilirubin, bile acids, blood ammonia, coagulation function, blood gases, vasoactive drugs, kidney function, serum lactate. (3) Liver ultrasound imaging on days 1, 7, 14, or before ICU transfer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Sham comparator | Drug: Saline, Drug: PlaceboPatients 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. |
| Intervention group | Experimental | Drug: Mecobalamin, Drug: Ceftriaxone SodiumPatients 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.-
Key exclusion criteria (10 listed)
- 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;
- Withdrawal of life support or anticipated life-threatening condition within 48 hours;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MecobalaminThe drug Mecobalamin in the intervention group was divided into intravenous and oral formulations, with the intravenous formulation being used for the first 14 days of the experiment and the oral formulation for the second 14 days. | Drug | Intervention group |
| Ceftriaxone SodiumCeftriaxone sodium all intravenous formulations | Drug | Intervention group |
| SalineThe saline used in the control group was the same as the saline used in the experimental group to dispense the drug | Drug | Control group |
| PlaceboPlacebo and Mecobalamin tablets look and smell the same. | Drug | Control group |
Primary outcome
total bilirubin
Time frame: 28 days or when patient is discharged/dead
Total bilirubin reduced to 17.1 μmol/L
bile acids
Time frame: 28 days or when patient is discharged/dead
Bile acids <10 μmol/L
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Background: PubMed 29691495Lelubre C, Vincent JL. Mechanisms and treatment of organ failure in sepsis. Nat Rev Nephrol. 2018 Jul;14(7):417-427. doi: 10.1038/s41581-018-0005-7.
- Background: PubMed 37041228He XL, Chen JY, Feng YL, Song P, Wong YK, Xie LL, Wang C, Zhang Q, Bai YM, Gao P, Luo P, Liu Q, Liao FL, Li ZJ, Jiang Y, Wang JG. Single-cell RNA sequencing deciphers the mechanism of sepsis-induced liver injury and the therapeutic effects of artesunate. Acta Pharmacol Sin. 2023 Sep;44(9):1801-1814. doi: 10.1038/s41401-023-01065-y. Epub 2023 Apr 11.
- Background: PubMed 37837715Jiao C, Zhang H, Li H, Fu X, Lin Y, Cao C, Liu S, Liu Y, Li P. Caspase-3/GSDME mediated pyroptosis: A potential pathway for sepsis. Int Immunopharmacol. 2023 Nov;124(Pt B):111022. doi: 10.1016/j.intimp.2023.111022. Epub 2023 Oct 12.
- Background: PubMed 32200645Pan C, Chen L, Lu C, Zhang W, Xia JA, Sklar MC, Du B, Brochard L, Qiu H. Lung Recruitability in COVID-19-associated Acute Respiratory Distress Syndrome: A Single-Center Observational Study. Am J Respir Crit Care Med. 2020 May 15;201(10):1294-1297. doi: 10.1164/rccm.202003-0527LE. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chun Pan, ph.D study director
Sichuan Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mecobalamin, Ceftriaxone Sodium and Saline in people with Sepsis and Liver Dysfunction, run by Sichuan Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sen Lu (13890741506, shenjun592021@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total bilirubin (time frame: 28 days or when patient is discharged/dead). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06220929, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.