- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01863121
Validation of Child-Turcotte-Pugh-Kumar (CTPK) Score in Predicting Short Term Mortality in Patients With Liver Cirrhosis
A Prospective Validation of Child-Turcotte-Pugh-Kumar (CTPK) Score in Predicting Short Term Mortality in Patients With Liver Cirrhosis
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Ashish kumar, M.D
- Phone Number: 091-9312792573
- Email: ashishk10@yahoo.com
Study Contact Backup
- Name: Praveen Sharma, M.D
- Phone Number: 091-9540951004
- Email: drpraveen_sharma@yahoo.com
Study Locations
-
-
-
New Delhi, India, 110060
- Recruiting
- Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital
-
Contact:
- Ashish kumar, M.D
- Phone Number: 091-9312792573
- Email: ashishk10@yahoo.com
-
Contact:
- Praveen Sharma, M.D
- Phone Number: 091-9540951004
- Email: drpraveen_sharma@yahoo.com
-
Principal Investigator:
- Ashish Kumar, M.D
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Cirrhotic Patients
Patients of cirrhosis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
1-week Survival
Time Frame: 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
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
2-week Survival
Time Frame: 2 weeks
|
2 weeks
|
1-month Survival
Time Frame: 1 month
|
1 month
|
2-month Survival
Time Frame: 2 months
|
2 months
|
3-month Survival
Time Frame: 3 months
|
3 months
|
6-month Survival
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ashish kumar, M..D, Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital
- Principal Investigator: Anil Arora, M.D, Department of Gatroenterology & Hepatology, Sir Gnaga Ram Hospital
- Principal Investigator: Praveen Sharma, M.D, Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital
- Principal Investigator: Pankaj tyagi, M.D, Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EC/04/13/503
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cirrhosis
-
Postgraduate Institute of Medical Education and...Society for the Study of Liver Diseases, Chandigarh ( India )UnknownDecompensated Cirrhosis of LiverIndia
-
University Health Network, TorontoUnknown
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.RecruitingPrimary Biliary CirrhosisChina
-
Northwestern UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA); National Cancer... and other collaboratorsRecruitingCirrhosis | Cirrhosis, Liver | Cirrhosis Due to Hepatitis B | Cirrhosis Due to Hepatitis C | Cirrhosis Early | Cirrhosis Advanced | Cirrhosis Infectious | Cirrhosis Alcoholic | Cirrhosis, Biliary | Cirrhosis Cryptogenic | Cirrhosis Due to Primary Sclerosing CholangitisUnited States
-
National Institute of Diabetes and Digestive and...National Institute on Alcohol Abuse and Alcoholism (NIAAA); National Cancer... and other collaboratorsRecruitingCirrhosis | Cirrhosis, Liver | Cirrhosis Due to Hepatitis B | Cirrhosis Due to Hepatitis C | Cirrhosis Early | Cirrhosis Advanced | Cirrhosis Infectious | Cirrhosis Alcoholic | Cirrhosis, Biliary | Cirrhosis Cryptogenic | Cirrhosis Due to Primary Sclerosing CholangitisUnited States
-
Institute of Liver and Biliary Sciences, IndiaNot yet recruitingDecompensated CirrhosisIndia
-
Milton S. Hershey Medical CenterNot yet recruitingCirrhosis, Liver
-
Beijing 302 HospitalWuhan Optics Valley Zhongyuan Pharmaceutical Co., Ltd., Hubei, ChinaNot yet recruitingDecompensated CirrhosisChina
-
The Cleveland ClinicRecruiting
-
Xin ZengRecruitingDecompensated CirrhosisChina