Acute Decompensation in Liver CirrhosisNCT03005587
Impact of Acute Decompensation in Patients of Cirrhosis With or Without Prior Decompensation
An observational study of Acute Decompensation in Liver Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
This a prospective observational study in Chronic Liver Disease patients admitted or seen in OPD, Department of Hepatology, Institute of Liver and Biliary Sciences, India. The study will be conducted in a period of three months starting September 2016 in sample size of 80 . Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Decompensation in Liver Cirrhosis
- How many people
- 0 participants
- Where
- 1 siteIndia
- Study dates
- 31 Dec 2016to 1 Mar 2017
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic liver disease patients admitted or seen in Out Patient Department, Department of Hepatology, Institute of Liver \& Biliary Sciences, India.
Who may be able to join
- Cirrhosis with decompensation in a period of 3 months in form of ascites, jaundice, Hepatic Encephalopathy, Acute Variceal bleed irrespective of prior decompensation.
- Age 18-70 years
- Valid consent
Who cannot join
- HepatoCellular Carcinoma
- Admitted and survival less than 48 hrs
- Pregnant
- Acute Liver Failure
- Post transplant
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver and Biliary Sciences.
New Delhi, National Capital Territory of Delhi, 110070
About this study
Official title: Impact of Acute Decompensation in Patients of Cirrhosis With or Without Prior Decompensation - A Prospective Observational Study.
This a prospective observational study in Chronic Liver Disease patients admitted or seen in OPD, Department of Hepatology, Institute of Liver and Biliary Sciences, India. The study will be conducted in a period of three months starting September 2016 in sample size of 80 . A detailed proforma including history and examination and routine blood investigations will be noted. The patients will undergo close follow up at 0, 7, 15, 30, 45, 60, 90 days and similar activities will be repeated at every visit.
- Conditions
- Acute Decompensation in Liver Cirrhosis
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 |
|---|---|---|
| Cirrhotics with no previous decompensation | Not described | |
| Cirrhotics with previous one or more than one decompensation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontaneous recovery or liver transplant or death in both groups
Measured: 90 days
Secondary outcomes (11)
Cause of acute decompensation
Measured: 3 months
Severity and duration of prior as well as present decompensation
Measured: 3 months
Improvement in severity assessment Indices Model for End Stage Liver Disease in both groups.
Measured: 3 months
Causes of death in both groups
Measured: 3 months
Profile of patient undergone transplant in both groups
Measured: 3 months
Sepsis in both groups
Measured: 3 months
Systemic Inflammatory Response Syndrome in both groups
Measured: 3 months
Improvement in severity assessment Indices Child Pugh Turcotte in both groups.
Measured: 3 months
Improvement in severity assessment Indices Sequential Organ Failure Assessment in both groups
Measured: 3 months
Improvement in severity assessment Indices Acute Physiology and Chronic Health Evaluation II in both groups
Measured: 3 months
Improvement in severity assessment Indices CLIF score in both groups
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study start31 Dec 2016 (estimated)
- Primary completion1 Mar 2017 (estimated)
- Study completion1 Mar 2017 (estimated)
Why it stopped: Lack of Funds
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Decompensation in Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03005587
- Sponsor's protocol ID
- ILBS-Cirrhosis-06
- Status last verified
- Jun 2018
- First submitted
- 23 Dec 2016
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Acute Decompensation in Patients of Cirrhosis With or Without Prior Decompensation - A Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT03005587
- Acronym / sponsor ID
- ILBS-Cirrhosis-06
- Conditions
- Acute Decompensation in Liver Cirrhosis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Lack of Funds
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 31 Dec 2016 (estimated)
- Primary completion
- 1 Mar 2017 (estimated)
- Study completion
- 1 Mar 2017 (estimated)
- First posted
- 29 Dec 2016 (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.
This a prospective observational study in Chronic Liver Disease patients admitted or seen in OPD, Department of Hepatology, Institute of Liver and Biliary Sciences, India. The study will be conducted in a period of three months starting September 2016 in sample size of 80 . A detailed proforma including history and examination and routine blood investigations will be noted. The patients will undergo close follow up at 0, 7, 15, 30, 45, 60, 90 days and similar activities will be repeated at every visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cirrhotics with no previous decompensation | – | – |
| Cirrhotics with previous one or more than one decompensation | – | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic liver disease patients admitted or seen in Out Patient Department, Department of Hepatology, Institute of Liver \& Biliary Sciences, India.
Key inclusion criteria (3 listed)
- Cirrhosis with decompensation in a period of 3 months in form of ascites, jaundice, Hepatic Encephalopathy, Acute Variceal bleed irrespective of prior decompensation.
- Age 18-70 years
- Valid consent
Key exclusion criteria (5 listed)
- HepatoCellular Carcinoma
- Admitted and survival less than 48 hrs
- Pregnant
- Acute Liver Failure
- Post transplant
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
Spontaneous recovery or liver transplant or death in both groups
Time frame: 90 days
11 secondary outcomes
Cause of acute decompensation
Time frame: 3 months
Severity and duration of prior as well as present decompensation
Time frame: 3 months
Improvement in severity assessment Indices Model for End Stage Liver Disease in both groups.
Time frame: 3 months
Causes of death in both groups
Time frame: 3 months
Profile of patient undergone transplant in both groups
Time frame: 3 months
Sepsis in both groups
Time frame: 3 months
Systemic Inflammatory Response Syndrome in both groups
Time frame: 3 months
Improvement in severity assessment Indices Child Pugh Turcotte in both groups.
Time frame: 3 months
Improvement in severity assessment Indices Sequential Organ Failure Assessment in both groups
Time frame: 3 months
Improvement in severity assessment Indices Acute Physiology and Chronic Health Evaluation II in both groups
Time frame: 3 months
Improvement in severity assessment Indices CLIF score in both groups
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Individual participant dataSharing planned: No
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Thrombelastometry-guided Blood Component Administration Versus Standard of Care in Patients With Decompensated Liver Cirrhosis Undergoing Invasive Procedures
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Acute Decompensation in Liver Cirrhosis, run by Institute of Liver and Biliary Sciences, India 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 3 inclusion and 5 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: withdrawn, as of the sponsor's last update on 26 Jun 2018. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spontaneous recovery or liver transplant or death in both groups (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2018.