Validation of Child-Turcotte-Pugh-Kumar (CTPK) Score in Predicting Short Term Mortality in Patients With Liver Cirrhosis
NCT ID: NCT01863121
Last Updated: 2017-04-28
Study Results
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Basic Information
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UNKNOWN
500 participants
OBSERVATIONAL
2013-05-31
2018-01-31
Brief Summary
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Detailed Description
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A new severity score was devised by us by modifying existing CTP Score adding to it the endoscopy parameter. The investigators modified the CTP score by adding the points for variceal bleed status of the patients as follows: history of variceal bleed present - 3 points; no history of variceal bleed but large (grade III-IV) varices present - 2 points; and no history of variceal bleed with small (grade I-II) or absent varices - 1 point. These points were added to the conventional CTP score to obtain the CTPK score (maximum score 18, minimum 6). CTPK score is a simple clinical tool and can be calculated at the bedside. It includes the component of portal hypertension, which is not present in the CTP score.
In a retrospective study conducted by the Principal Investigator the CTPK score was found to better predict the short term mortality (1 week, 2 week mortality regardless of treatment) in patients of cirrhosis. It performs significantly better than the CTP score in predicting early mortality, especially at 1 and 2 weeks in cirrhotics. Further prospective validation of this score was warranted. Hence this study aims to prospectively validate the CTPK score for predicting short term mortality in a cohort study of cirrhosis admitted in Sir Ganga Ram Hospital.
STUDY OBJECTIVE
Comparison of CTP score, MELD score with new CTPK score in predicting the mortality at 1 week (primary objective), and at 2 weeks, 1 month, 2 months, 3 months and 6 months (secondary objectives), regardless of the treatment offered.
Primary objective Prediction of short term mortality (1 week)
Secondary objective Prediction of long term mortality 2 weeks, 1 month, 2 months, 3 months and 6 months
All patients of cirrhosis of liver who are admitted in department of gastroenterology \& hepatology (Unit - 1, either as inpatient or day care), Sir Ganga Ram Hospital for any reason will be enrolled in study after taking consent \& who fit in inclusion criterion. The patients will be subjected to routine evaluation for etiology of cirrhosis and its complications. Severity assessment of cirrhosis will be done by CTP score, MELD score and in addition by new CTPK score. Patients will be treated as per discretion of treating physician. Then patients will be followed up for 6 months at defined intervals. The follow up will be taken as per following time intervals: 1 week, 2 week, 1 month, 2 months 3 months and 6 months. The only parameter assessed in follow up will be their survival.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cirrhotic Patients
Patients of cirrhosis
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Age between 18 - 75 years
* Admitted in Unit 1 Department of Gastroenterology \& Hepatology
* Patients/ LAR who are willing to give written informed consent
Exclusion Criteria
* Any malignancy including HCC (Hepatocellular Carcinoma)
* Patients who refuse to give consent
18 Years
75 Years
ALL
No
Sponsors
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Sir Ganga Ram Hospital
OTHER
Responsible Party
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Dr. Ashish Kumar
Associate professor & Consultant
Principal Investigators
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Ashish kumar, M..D
Role: PRINCIPAL_INVESTIGATOR
Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital
Anil Arora, M.D
Role: PRINCIPAL_INVESTIGATOR
Department of Gatroenterology & Hepatology, Sir Gnaga Ram Hospital
Praveen Sharma, M.D
Role: PRINCIPAL_INVESTIGATOR
Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital
Pankaj tyagi, M.D
Role: PRINCIPAL_INVESTIGATOR
Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital
Locations
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Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital
New Delhi, , India
Countries
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Central Contacts
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Facility Contacts
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References
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Kumar A, Sharma P, Sarin SK. Adding variceal status to Child-Turcotte-Pugh score improves its performance in predicting early mortality in cirrhosis: the Child-Turcotte-Pugh-Kumar score. Eur J Gastroenterol Hepatol. 2012 Nov;24(11):1348-9. doi: 10.1097/MEG.0b013e3283579475. No abstract available.
Other Identifiers
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EC/04/13/503
Identifier Type: -
Identifier Source: org_study_id
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