A Prospective Validation of Child-Turcotte-Pugh-Kumar (CTPK) Score in Predicting Short Term Mortality in Patients With Liver Cirrhosis
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- 1-week Survival
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients with significant cardiopulmonary illness
- •Any malignancy including HCC (Hepatocellular Carcinoma)
- •Patients who refuse to give consent
结局指标
主要结局
1-week Survival
时间窗: 1 week
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
次要结局
- 6-month Survival(6 months)
- 2-month Survival(2 months)
- 3-month Survival(3 months)
- 2-week Survival(2 weeks)
- 1-month Survival(1 month)
研究者
Dr. Ashish Kumar
Associate professor & Consultant
Sir Ganga Ram Hospital