CirrhosisNCT01863121
Validation of Child-Turcotte-Pugh-Kumar (CTPK) Score in Predicting Short Term Mortality in Patients With Liver Cirrhosis
An observational study of Cirrhosis, run by Sir Ganga Ram Hospital at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cirrhosis
- How many people
- 500 participants
- Where
- 1 siteIndia
- Study dates
- May 2013to Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient of cirrhosis Age between 18 - 75 years
Who may be able to join
- 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
Who cannot join
- Patients with significant cardiopulmonary illness
- Any malignancy including HCC (Hepatocellular Carcinoma)
- Patients who refuse to give consent
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital
New Delhi, 110060
Ashish kumar, M.D, 091-9312792573, ashishk10@yahoo.com
Praveen Sharma, M.D, 091-9540951004, drpraveen_sharma@yahoo.com
About this study
Official title: A Prospective Validation of Child-Turcotte-Pugh-Kumar (CTPK) Score in Predicting Short Term Mortality in Patients With Liver Cirrhosis
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.
Read the 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.
- Conditions
- Cirrhosis
- Keywords
- cirrhosis, CTPK, CTP, MELD, Severity Score
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cirrhotic Patients | Patients of cirrhosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 week
Secondary outcomes (5)
2-week Survival
Measured: 2 weeks
1-month Survival
Measured: 1 month
2-month Survival
Measured: 2 months
3-month Survival
Measured: 3 months
6-month Survival
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2013 (estimated)
- Study startMay 2013
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Ganga Ram Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ashish Kumar, Sir Ganga Ram Hospital
- Investigators
- Ashish kumar, M..D, Principal investigator, Department of Gastroenterology & Hepatology, Sir Ganga Ram HospitalAnil Arora, M.D, Principal investigator, Department of Gatroenterology & Hepatology, Sir Gnaga Ram HospitalPraveen Sharma, M.D, Principal investigator, Department of Gastroenterology & Hepatology, Sir Ganga Ram HospitalPankaj tyagi, M.D, Principal investigator, Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01863121
- Sponsor's protocol ID
- EC/04/13/503
- Status last verified
- Apr 2017
- First submitted
- 21 May 2013
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23022921
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Validation of Child-Turcotte-Pugh-Kumar (CTPK) Score in Predicting Short Term Mortality in Patients With Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT01863121
- Acronym / sponsor ID
- EC/04/13/503
- Conditions
- Cirrhosis
- Keywords
- cirrhosis, CTPK, CTP, MELD, Severity Score
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Sir Ganga Ram HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 27 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cirrhotic Patients | – | –Patients of cirrhosis |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient of cirrhosis Age between 18 - 75 years
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Patients with significant cardiopulmonary illness
- Any malignancy including HCC (Hepatocellular Carcinoma)
- Patients who refuse to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 secondary outcomes
2-week Survival
Time frame: 2 weeks
1-month Survival
Time frame: 1 month
2-month Survival
Time frame: 2 months
3-month Survival
Time frame: 3 months
6-month Survival
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
- Background: PubMed 23022921Kumar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashish kumar, M..D principal investigator
Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital
Anil Arora, M.D principal investigator
Department of Gatroenterology & Hepatology, Sir Gnaga Ram Hospital
Praveen Sharma, M.D principal investigator
Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis, run by Sir Ganga Ram Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ashish Kumar, M.D (091-9312792573, ashishk10@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-week Survival (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01863121, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2017.