Validation of Child-Turcotte-Pugh-Kumar (CTPK) Score in Predicting Short Term Mortality in Patients With Liver Cirrhosis

Cirrhosis Clinical Trial

Official title:

A Prospective Validation of Child-Turcotte-Pugh-Kumar (CTPK) Score in Predicting Short Term Mortality in Patients With Liver Cirrhosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01863121
• Other study ID #: EC/04/13/503
• Status: Recruiting
• Phase: N/A
• First received: May 21, 2013
• Last updated: April 27, 2017
• Start date: May 2013
• Est. completion date: January 2018

Study information

• Verified date: April 2017
• Source: Sir Ganga Ram Hospital
• Contact: Ashish Kumar, M.D
• Phone: 091-9312792573
• Email: ashishk10[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The CTP score is one of the best proved severity score in predicting mortality in patients with cirrhosis. Portal hypertension and variceal bleed are significant causes of morbidity and mortality in patients with cirrhosis. The recently published CTPK score included variceal variceal bleed status to the CTP score which improved the accuracy of CTP score in predicting short term mortality. CTPK score needs prospective validation.

Description:

Once patients with cirrhosis experience decompensation, early mortality risk increases sharply. Child-Pugh score has been the reference for many years for assessing the prognosis of cirrhosis. The model for end-stage liver disease (MELD) score, which was originally designed for assessing the prognosis of cirrhotic patients undergoing transjugular intrahepatic portosystemic shunt (TIPS), is a continuous score relying on three objective variables. Both CTP and MELD scores do not have portal hypertension as one of the parameters. The investigators already know that portal hypertension is also an independent prediction of mortality in patients of cirrhosis, however, both these scores fail to include portal hypertension component in prediction of mortality.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patient of cirrhosis

• 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:

• Patients with significant cardiopulmonary illness

• Any malignancy including HCC (Hepatocellular Carcinoma)

• Patients who refuse to give consent

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis
• Liver Cirrhosis

Locations

Country	Name	City	State
India	Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital	New Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Sir Ganga Ram Hospital

Country where clinical trial is conducted

India, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1-week Survival	Severity assessment of cirrhosis will be done by CTP score, MELD score and in addition by CTPK score. Patients will be treated as per discretion of treating physician. Survival will be assessed at 1 week	1 week
Secondary	2-week Survival		2 weeks
Secondary	1-month Survival		1 month
Secondary	2-month Survival		2 months
Secondary	3-month Survival		3 months
Secondary	6-month Survival		6 months