Decompensated CirrhosisNCT07794787
To Develop and Validate an Equation for Determination of Major Adverse Kidney Events in Patients With Decompensated Cirrhosis and Ascites.
An observational study of Decompensated Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Acute kidney injury (AKI) is the sudden loss of kidney function that occurs frequently in hospitalised patients with cirrhosis. It develops in up to 53% and is independently associated with high short-term mortality. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Decompensated Cirrhosis
- How many people
- 400 participants
- Where
- 1 siteIndia
- Study dates
- 31 Aug 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with cirrhosis and ascites admitted in ILBS.
Who may be able to join
- Patients of cirrhosis with ascites with stable renal functions in last 7 days (variability in gfr < 15 % and no AKI).
Who cannot join
- Patients with age <18 or more than 65 years
- Obstructive uropathy or intrinsic kidney disease
- Patients with multiorgan failure or requiring mechanical ventilation
- Patients who had previously undergone Liver or Kidney transplant
- Patients with missing laboratory measurements within 24 hours of admission
- HCC
Show all 11Show fewer
- Pregnant
- Lack of baseline serum creatinine
- Need of renal replacement therapy
- HVOTO
- Severe comorbid cardiopulmonary diseases or extrahepatic malignancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, 110070
Dr Gnana Kavitha, MD, 01146300000, drkavitha777@gmail.com
About this study
Official title: To Develop and Validate an Equation for Determination of Major Adverse Kidney Events in Patients With Decompensated Cirrhosis and Ascites- A Prospective Cohort Study
Acute kidney injury (AKI) is the sudden loss of kidney function that occurs frequently in hospitalised patients with cirrhosis.
- It develops in up to 53% and is independently associated with high short-term mortality.
- A diagnosis of AKI (even stage 1 AKI) has been shown to be associated with an increased risk of long-term mortality at 30-day, 90-day and 1-year, compared to patients without AKI, even when there is recovery of AKI.
- Risk factors with the strongest association for developing AKI include CKD, sepsis, spontaneous bacterial peritonitis (SBP), and presence of ascites.
- AKI in cirrhosis is also associated with development of de-novo chronic kidney disease (CKD) , progressive loss of kidney function in patients with pre-existing CKD,recurrent AKI (i.e., AKI on top of CKD) and other organ failures
- Kidney dysfunction in patients with cirrhosis is associated with a marked increase in mortality compared with patients without kidney dysfunction.
- The accurate estimation of kidney function in patients with cirrhosis is hence crucial for prognosis, treatment strategies, and decisions regarding simultaneous liver-kidney transplantation (SLKT).
- Although measured GFR(mGFR) may be ideal for assessing kidney function, it is costly, time-consuming, and challenging to perform frequently in fluctuating kidney function. Therefore, GFR is most commonly estimated using serum creatinine (sCr)-based or cystatin C (CysC)-based equations
- Conditions
- Decompensated 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 |
|---|---|---|
| Cirrhosis with ascites | Patients with cirrhosis and ascites admitted in ILBS. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Kidney Events at 1 year.
Make is defined as the composite outcome of ≥25% decline in estimated-glomerular-filtration-rate (eGFR) compared with baseline with the development of de-novo chronic-kidney-disease (CKD) stage ≥3 or CKD progression (≥50% reduction in eGFR compared with baseline or new haemodialysis or death.
Measured: 1 year
Secondary outcomes (6)
Validation and comparision of new equation with known equations of GFR
Measured: 1 year
Cumulative incidence of AKI and its impact on MAKE
Measured: 1 year
AKD and CKD development
Measured: 1 year
Development of Liver related decompensating events: worsening of ascites, acute Variceal bleed,SBP and non-SBP infections, hepatic encephalopathy,Hepatocellular carcinoma
Measured: 1 year
Need for Liver transplant or simultaneous liver kidney transplant
Measured: 1 year
Numbers of hospitalisations
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start31 Aug 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decompensated 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
- 400 participants (estimated)
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
- NCT07794787
- Sponsor's protocol ID
- ILBS-Cirrhosis-77
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Develop and Validate an Equation for Determination of Major Adverse Kidney Events in Patients With Decompensated Cirrhosis and Ascites- A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07794787
- Acronym / sponsor ID
- ILBS-Cirrhosis-77
- Conditions
- Decompensated Cirrhosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 31 Aug 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 31 Aug 2026 (actual)
- 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.
Acute kidney injury (AKI) is the sudden loss of kidney function that occurs frequently in hospitalised patients with cirrhosis.
- It develops in up to 53% and is independently associated with high short-term mortality.
- A diagnosis of AKI (even stage 1 AKI) has been shown to be associated with an increased risk of long-term mortality at 30-day, 90-day and 1-year, compared to patients without AKI, even when there is recovery of AKI.
- Risk factors with the strongest association for developing AKI include CKD, sepsis, spontaneous bacterial peritonitis (SBP), and presence of ascites.
- AKI in cirrhosis is also associated with development of de-novo chronic kidney disease (CKD) , progressive loss of kidney function in patients with pre-existing CKD,recurrent AKI (i.e., AKI on top of CKD) and other organ failures
- Kidney dysfunction in patients with cirrhosis is associated with a marked increase in mortality compared with patients without kidney dysfunction.
- The accurate estimation of kidney function in patients with cirrhosis is hence crucial for prognosis, treatment strategies, and decisions regarding simultaneous liver-kidney transplantation (SLKT).
- Although measured GFR(mGFR) may be ideal for assessing kidney function, it is costly, time-consuming, and challenging to perform frequently in fluctuating kidney function. Therefore, GFR is most commonly estimated using serum creatinine (sCr)-based or cystatin C (CysC)-based equations
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cirrhosis with ascites | – | –Patients with cirrhosis and ascites admitted in ILBS. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cirrhosis and ascites admitted in ILBS.
Key inclusion criteria (1 listed)
- Patients of cirrhosis with ascites with stable renal functions in last 7 days (variability in gfr < 15 % and no AKI).
Key exclusion criteria (11 listed)
- Patients with age <18 or more than 65 years
- Obstructive uropathy or intrinsic kidney disease
- Patients with multiorgan failure or requiring mechanical ventilation
- Patients who had previously undergone Liver or Kidney transplant
- Patients with missing laboratory measurements within 24 hours of admission
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
Major Adverse Kidney Events at 1 year.
Time frame: 1 year
Make is defined as the composite outcome of ≥25% decline in estimated-glomerular-filtration-rate (eGFR) compared with baseline with the development of de-novo chronic-kidney-disease (CKD) stage ≥3 or CKD progression (≥50% reduction in eGFR compared with baseline or new haemodialysis or death.
6 secondary outcomes
Validation and comparision of new equation with known equations of GFR
Time frame: 1 year
Cumulative incidence of AKI and its impact on MAKE
Time frame: 1 year
AKD and CKD development
Time frame: 1 year
Development of Liver related decompensating events: worsening of ascites, acute Variceal bleed,SBP and non-SBP infections, hepatic encephalopathy,Hepatocellular carcinoma
Time frame: 1 year
Need for Liver transplant or simultaneous liver kidney transplant
Time frame: 1 year
Numbers of hospitalisations
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
Related trials for Decompensated Cirrhosis
Not yet recruitingObservational study
Risk Stratification for Adverse Events in End-Stage Liver Disease
Decompensated Cirrhosis
RecruitingObservational study
VIATORR® TIPS Study Evaluating 6-10mm Diameters (VIATIPS)
Ascites, Variceal Bleeding
Active, not recruitingPhase 1/2
RTX001 Autologous Engineered Macrophages for Liver Cirrhosis
End-stage Liver Disease (ESLD), Cirrhosis, Liver
Recruiting
Hospital @ Home Model of Care for Cirrhosis
Decompensated Cirrhosis
Not yet recruiting
Impact of Propranolol on the Prognosis of Patients With Decompensated Cirrhosis and MELD Score > 9
Cirrhosis
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.
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 Decompensated 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 1 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 18 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Gnana Kavitha, MD (01146300000, kavuluj4444@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Kidney Events at 1 year. (time frame: 1 year). 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 18 Sep 2026.