Clinical trial NCT01863121: Validation of Child-Turcotte-Pugh-Kumar (CTPK) Score in Predicting Short Term Mortality in Patients With Liver Cirrhosis
Official title: A Prospective Validation of Child-Turcotte-Pugh-Kumar (CTPK) Score in Predicting Short Term Mortality in Patients With Liver Cirrhosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cirrhosis
Keywords: cirrhosis
CTPK
CTP
MELD
Severity Score
Lead sponsor: Sir Ganga Ram Hospital
Sponsor class: OTHER
First posted: 2013-05-27
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient of cirrhosis Age between 18 - 75 years

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 1-week Survival
timeFrame: 1 week
Secondary outcomes:
measure: 2-week Survival
timeFrame: 2 weeks
measure: 1-month Survival
timeFrame: 1 month
measure: 2-month Survival
timeFrame: 2 months
measure: 3-month Survival
timeFrame: 3 months
measure: 6-month Survival
timeFrame: 6 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital
Study officials:
affiliation: Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital
name: Ashish kumar, M..D
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Gatroenterology & Hepatology, Sir Gnaga Ram Hospital
name: Anil Arora, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital
name: Praveen Sharma, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital
name: Pankaj tyagi, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.