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Nomogram Analysis for HBV Related Acute-on-chronic Liver Failure
Acute-on-chronic liver failure (ACLF) is an acute deterioration of chronic liver diseases, which progresses rapidly, with a mortality rate of more than 50%.MELD score is used to evaluate the patients' condition. However, MELD score only concerned about the variables of total bilirubin, international normalize ratio (INR) and creatinine which is not enough to access ACLF patients' condition accurately.
Scholars of US and China suggested to divided ACLF patients into 3 subgroups base on the different "chronic liver disease" . Type A ACLF patients have chronic liver disease without cirrhosis. Type B ACLF patients with compensated cirrhosis, while type C ACLF patients with decompensated cirrhosis. Currently, no studies have assessed the prognosis of different types of ACLF patients, especially for HBV-related ACLF patients.
Investigators conducted a retrospective study which enrolls HBV-related ACLF patients between January 2010 and March 2018 in the Third Affiliated Hospital of Sun Yat-sen University. Clinical data, survival time and information regarding liver transplantation after enrolment were collected. A nomogram was formulated based on the results of multivariable Cox regression analysis. The performance of the nomogram was evaluated by the concordance index (C-index) and assessed by comparing nomogram-predicted vs observed Kaplan-Meier estimates of survival probability, and bootstraps with 1000 resamples were applied to these activities. Comparisons between the nomogram, MELD Score，MELD-Na Score and CTP Score in the entire population were performed and were tested by the C-index. A larger C-index indicated more accurate prognostic stratification.
| Condition or disease | Intervention/treatment |
|---|---|
| Liver Failure | Other: No special intervention was suitable for this observational study |
Acute-on-chronic liver failure (ACLF) is an acute deterioration of chronic liver diseases, which progresses rapidly, with a mortality rate of more than 50%. Liver transplantation is the only therapy that has been proven beneficial, but the number of liver donor is limited. MELD score is used to evaluate the patients' condition before transplantation to decide who is in greatest need. However, MELD score only concerned about the variables of total bilirubin, international normalize ratio (INR) and creatinine. Other important valuables such as age, hepatic encephalopathy, and indexes of infection (e.g. white blood cell counts) were excluded. Many studies showed that application of MELD score only is not enough to access the liver failure patients' condition accurately.
Both APASL and Chinese Society of Infectious Disease considered the "chronic liver disease" included chronic liver disease with/without cirrhosis. Scholars of US and China suggested to divided ACLF patients into 3 subgroups base on the different "chronic liver disease" . Type A ACLF patients have chronic liver disease without cirrhosis. Type B ACLF patients with compensated cirrhosis, while type C ACLF patients with decompensated cirrhosis. Currently, no studies have assessed the prognosis of different types of ACLF patients, especially for HBV-related ACLF patients.
Investigators conducted a retrospective study which enrolls HBV-related ACLF patients between January 2010 and March 2018 in the Third Affiliated Hospital of Sun Yat-sen University. Clinical data of demographic data, admission causes, cirrhosis complications, and precipitating events associated with acute decompensation or severe liver injury, laboratory measurements (e.g., serum albumin, sodium, alanine aminotransferase, aspartate aminotransferase, total bilirubin, INR and creatinine levels), mean arterial pressure, HBV infection biomarkers, HBV-DNA levels, antiviral treatment for HBV (nucleoside analogues, including lamivudine, adefovir, entecavir, telbivudine and tenofovir, within 6 months prior to and during hospitalisation), and prognosis would be collected. Survival time and information regarding liver transplantation after enrolment were also collected. A nomogram was formulated based on the results of multivariable Cox regression analysis. The performance of the nomogram was evaluated by the concordance index (C-index) and assessed by comparing nomogram-predicted vs observed Kaplan-Meier estimates of survival probability, and bootstraps with 1000 resamples were applied to these activities. Comparisons between the nomogram, MELD Score, MELD-Na Score and CTP Score in the entire population were performed and were tested by the C-index. A larger C-index indicated more accurate prognostic stratification.
| Study Type : | Observational |
| Actual Enrollment : | 2739 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | Establishment and Validation of Prognostic Nomograms for HBV-related Acute-on-Chronic Liver Failure in South of China |
| Actual Study Start Date : | January 1, 2019 |
| Actual Primary Completion Date : | October 1, 2019 |
| Actual Study Completion Date : | November 1, 2019 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
Chronic hepatitis cohort
In this cohort, patients were defined as type A acute-on-chronic liver failure (ACLF) patients who have chronic liver disease but without cirrhosis.
|
Other: No special intervention was suitable for this observational study
Investegators divided patients into 3 corhort according to the liver condition at enrollment (i.e. chronic liver disease, compemsated cirrhosis, decompensated cirrhosis). All patients received standard medical treatment, including nutritional supplementation; administration of human serum albumin, fresh frozen plasma, antivirus treatment and appropriate treatment for complications. No special intervention was suitable for this observational study.
|
|
Cirrhosis cohort
In this cohort, patients were defined as type B and type C ACLF patients with cirrhosis.
|
Other: No special intervention was suitable for this observational study
Investegators divided patients into 3 corhort according to the liver condition at enrollment (i.e. chronic liver disease, compemsated cirrhosis, decompensated cirrhosis). All patients received standard medical treatment, including nutritional supplementation; administration of human serum albumin, fresh frozen plasma, antivirus treatment and appropriate treatment for complications. No special intervention was suitable for this observational study.
|
- survival status [ Time Frame: 90 days ]Patients will be follow-up for 90 days until death or received liver transplantation. And survival days of each patients will be recorded.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
- Age ≥ 18 years; Serum total bilirubin ≥ 10 mg/dl; International normalized ratio≥1.5 or prothrombin activity <40%; Complicated within 4 weeks by ascites and/or encephalopathy; Positive serum hepatitis B surface antigen for more than 6 months.
Exclusion Criteria:
- Drug induce liver diseases; Autoimmune liver diseases; Alcohol or drug abusers (average alcohol consumption >40g/d for men, >20g/d for women); Liver diseases caused by metabolic factors; Superinfection with hepatitis A, C, D, E viruses; Infected by HIV virus; Pregnancy or lactation; Liver failure caused by recurrence of hepatitis b after transplantation.
| China, Guangdong | |
| The Third Affiliated Hospital of Sun Yat-sen University | |
| Guangzhou, Guangdong, China, 510630 | |
| Principal Investigator: | Bingliang Lin, Doctor | Third Affiliated Hospital, Sun Yat-Sen University |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | June 19, 2019 | ||||
| First Posted Date | June 20, 2019 | ||||
| Last Update Posted Date | January 6, 2020 | ||||
| Actual Study Start Date | January 1, 2019 | ||||
| Actual Primary Completion Date | October 1, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
survival status [ Time Frame: 90 days ] Patients will be follow-up for 90 days until death or received liver transplantation. And survival days of each patients will be recorded.
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| Original Primary Outcome Measures |
survival status [ Time Frame: 90 days ] Patients will be follow-up for 90 days until death or received liver transplantation
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| Change History | |||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Nomogram Analysis for HBV Related Acute-on-chronic Liver Failure | ||||
| Official Title | Establishment and Validation of Prognostic Nomograms for HBV-related Acute-on-Chronic Liver Failure in South of China | ||||
| Brief Summary |
Acute-on-chronic liver failure (ACLF) is an acute deterioration of chronic liver diseases, which progresses rapidly, with a mortality rate of more than 50%.MELD score is used to evaluate the patients' condition. However, MELD score only concerned about the variables of total bilirubin, international normalize ratio (INR) and creatinine which is not enough to access ACLF patients' condition accurately. Scholars of US and China suggested to divided ACLF patients into 3 subgroups base on the different "chronic liver disease" . Type A ACLF patients have chronic liver disease without cirrhosis. Type B ACLF patients with compensated cirrhosis, while type C ACLF patients with decompensated cirrhosis. Currently, no studies have assessed the prognosis of different types of ACLF patients, especially for HBV-related ACLF patients. Investigators conducted a retrospective study which enrolls HBV-related ACLF patients between January 2010 and March 2018 in the Third Affiliated Hospital of Sun Yat-sen University. Clinical data, survival time and information regarding liver transplantation after enrolment were collected. A nomogram was formulated based on the results of multivariable Cox regression analysis. The performance of the nomogram was evaluated by the concordance index (C-index) and assessed by comparing nomogram-predicted vs observed Kaplan-Meier estimates of survival probability, and bootstraps with 1000 resamples were applied to these activities. Comparisons between the nomogram, MELD Score，MELD-Na Score and CTP Score in the entire population were performed and were tested by the C-index. A larger C-index indicated more accurate prognostic stratification. |
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| Detailed Description |
Acute-on-chronic liver failure (ACLF) is an acute deterioration of chronic liver diseases, which progresses rapidly, with a mortality rate of more than 50%. Liver transplantation is the only therapy that has been proven beneficial, but the number of liver donor is limited. MELD score is used to evaluate the patients' condition before transplantation to decide who is in greatest need. However, MELD score only concerned about the variables of total bilirubin, international normalize ratio (INR) and creatinine. Other important valuables such as age, hepatic encephalopathy, and indexes of infection (e.g. white blood cell counts) were excluded. Many studies showed that application of MELD score only is not enough to access the liver failure patients' condition accurately. Both APASL and Chinese Society of Infectious Disease considered the "chronic liver disease" included chronic liver disease with/without cirrhosis. Scholars of US and China suggested to divided ACLF patients into 3 subgroups base on the different "chronic liver disease" . Type A ACLF patients have chronic liver disease without cirrhosis. Type B ACLF patients with compensated cirrhosis, while type C ACLF patients with decompensated cirrhosis. Currently, no studies have assessed the prognosis of different types of ACLF patients, especially for HBV-related ACLF patients. Investigators conducted a retrospective study which enrolls HBV-related ACLF patients between January 2010 and March 2018 in the Third Affiliated Hospital of Sun Yat-sen University. Clinical data of demographic data, admission causes, cirrhosis complications, and precipitating events associated with acute decompensation or severe liver injury, laboratory measurements (e.g., serum albumin, sodium, alanine aminotransferase, aspartate aminotransferase, total bilirubin, INR and creatinine levels), mean arterial pressure, HBV infection biomarkers, HBV-DNA levels, antiviral treatment for HBV (nucleoside analogues, including lamivudine, adefovir, entecavir, telbivudine and tenofovir, within 6 months prior to and during hospitalisation), and prognosis would be collected. Survival time and information regarding liver transplantation after enrolment were also collected. A nomogram was formulated based on the results of multivariable Cox regression analysis. The performance of the nomogram was evaluated by the concordance index (C-index) and assessed by comparing nomogram-predicted vs observed Kaplan-Meier estimates of survival probability, and bootstraps with 1000 resamples were applied to these activities. Comparisons between the nomogram, MELD Score, MELD-Na Score and CTP Score in the entire population were performed and were tested by the C-index. A larger C-index indicated more accurate prognostic stratification. |
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| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | The investigators will enroll a retrospective cohort of HBV related acute-on-chronic liver failure patients who were admitted to The Third affiliated Hospital of Sun Yat-sen University from January 2010 to March 2018. | ||||
| Condition | Liver Failure | ||||
| Intervention | Other: No special intervention was suitable for this observational study
Investegators divided patients into 3 corhort according to the liver condition at enrollment (i.e. chronic liver disease, compemsated cirrhosis, decompensated cirrhosis). All patients received standard medical treatment, including nutritional supplementation; administration of human serum albumin, fresh frozen plasma, antivirus treatment and appropriate treatment for complications. No special intervention was suitable for this observational study.
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| Study Groups/Cohorts |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
2739 | ||||
| Original Estimated Enrollment |
2500 | ||||
| Actual Study Completion Date | November 1, 2019 | ||||
| Actual Primary Completion Date | October 1, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | China | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03992898 | ||||
| Other Study ID Numbers | Survival Study Cohort(SSC001) | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Lin Bingliang, Sun Yat-sen University | ||||
| Study Sponsor | Sun Yat-sen University | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Sun Yat-sen University | ||||
| Verification Date | January 2020 | ||||
