Liver CirrhosisNCT06809088
Comparison of Safety and Efficacy of Tailored Versus Fixed Dose Albumin for the Management of Patients With Cirrhosis and Sepsis Associated Acute Kidney Injury
A study testing Albumin and Standard Medical Treatment in people with Liver Cirrhosis and Acute Kidney Injury, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Acute kidney injury accompanies about 20% of hospitalized patients with cirrhosis and in about 40% of those admitted to ICU.A critically ill patient with cirrhosis refers to an individual who has advanced liver disease (cirrhosis) and is experiencing severe and potentially life-threatening complications that require… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Cirrhosis, Acute Kidney Injury
- What is being tested?
- Albumin and Standard Medical Treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 31 Jan 2025to 31 Jan 2026
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 and <70
- patients with cirrhosis and AKI with sepsis.
Who cannot join
- AKI- secondary to post renal causes such as nephrolithiasis
- Patient already on maintenance hemodialysis/RRT
- Patients with shock requiring vasopressors
- Patient with history of structural heart disease and LVEF < 50%
- Patient with known COPD
- Patient on Mechanical ventilation with P/F ratio <200
Show all 14Show fewer
- Patient with POCUS based features of volume overload[Presence of B lines ]
- HCC - Beyond MILAN criteria
- Patient in need of surgical intervention
- Patient with history of adverse reaction to Albumin infusion
- Pregnant or Lactating Women
- Portal or hepatic vein thrombosis
- Volume Overload with baseline IVC >20
- Failure to provide informed consent
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
Institute of liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
Dr Shreyas Sarvesh, MD, 01146300000, shreyassarvesh@gmail.com
About this study
Official title: Comparison of Safety and Efficacy of Tailored Versus Fixed Dose Albumin for the Management of Patients With Cirrhosis and Sepsis Associated Acute Kidney Injury - A Randomised Control Trial
Acute kidney injury accompanies about 20% of hospitalized patients with cirrhosis and in about 40% of those admitted to ICU.A critically ill patient with cirrhosis refers to an individual who has advanced liver disease (cirrhosis) and is experiencing severe and potentially life-threatening complications that require intensive medical care and monitoring. These complications might include hepatic encephalopathy, acute liver failure, severe bleeding due to portal hypertension, or other organ failures. Such patients often require specialized medical attention and interventions to stabilize their condition. The short-term prognosis of cirrhotic patients with acute kidney injury is poor, with a mortality rate higher than 65% in patients with RRT requirement. Patients with cirrhosis are prone to develop AKI . HRS comprises specific form of AKI[HRS-AKI] in patients with advanced cirrhosis and ascites, carries a high mortality risk. Role of albumin as colloid serves both as volume supplement and also as additive to vasoconstrictors. Ascites, elevated bilirubin, spontaneous bacterial peritonitis [SBP] and use of amino glycosides antibiotics had previously been identified as significant risk factors for renal failure in cirrhotic patients. The causes of AKI in cirrhotic patients include HRS [most common], others include ATN [associated mostly with sepsis]and hypovolemic shock. Three month survival ranged from 73% in patients with parenchymatous AKI to 15% for HRS. As per 2023 joint meeting of ICA and ADQI ,based on baseline serum creatinine[sCr](a lowest value obtained within the previous 3 months),AKI is defined by an absolute increases of sCr>=0.3mg/dl within 48hr or a percentage increase of sCr>=50% from baseline within 7 days and urine output <= 0.5ml/kg for >=6hrs.As per KDIGO ,three stages of AKI are defined :Stage 1]when the previous criteria are met [a relative increase of sCr 1.5-2.0from baseline, stage 2]when increase in sCr is >2folds to 3 folds from baseline and Stage 3]when there is an increase of sCr>3 folds from baseline or sCr is >4.0mg/dl with an acute increase of >0.3mg/dl or initiation of RRT. So, the study aims to analyze the role of albumin as a volume supplement and as a vasoconstrictor as well as its immunomodulatory effect in sepsis to help in resolution of AKI.Here we compare the effectiveness of personalized-dose albumin administration with fixed-dose albumin for treating acute kidney injury in patients with cirrhosis and sepsis associated AKI.
Read the detailed description
Study population:
- Age - 18-70 years
Study design: Monocentric open label randomised controlled study. The study will be conducted in Department of Hepatology ILBS.
Primary Objective : Effect of personalized dose of albumin compared to fixed dose protocol in improving AKI resolution at 48 hrs.
Secondary objectives:
- To study the cumulative dose of albumin in both groups.
- Time to AKI resolution and initiation of vasoconstrictors in both the groups
- Incidence of cardiopulmonary complications in both groups
- Impact of dose of albumin on cardiac function [including CVP and IVC], intraabdominal pressure and renal perfusion [assessed by renal artery resistive index] in both groups at 24 hr and 48 hrs.
- To study the role of intraabdominal pressure, Lung USG , biomarkers of cardiac dysfunction [NT Pro BNP, Troponin T] in predicting the development of cardiopulmonary complications and AKI outcomes.
- To study the duration of AKI and need of dialysis in both groups.
- 28-day mortality in both groups
Stopping Rule:
- With the development of cardiorespiratory adverse effects
- Increase in Heart rate > 10 from basal value
- Increase in RR > 20/min
- Temp > 1000 F
- SpO2 < 96%
- B lines in Lung USG
- IVC >= 20 with collapsibility <50% or distensibilty <18%
- Development of allergy
- On worsening shock ,if Noradrenaline requirement increases >0.1mcg/kg bw/min
- worsening AKI with a]decrease in urine output b]Need of Terlipressin c]Start of RRT
- If Downstaging of AKI does not occur on 48hr of Albumin infusion then based on GFR and urine output decision to add vasoconstrictor to be taken
- Conditions
- Liver Cirrhosis, Acute Kidney Injury
- Being tested
- Albumin, Standard Medical Treatment
- Medical subject headings
- Liver Cirrhosis, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlbuminBiological
Albumin
Standard Medical TreatmentOther
Standard Medical Treatment
| Study group | Role | What they receive |
|---|---|---|
| Personalized Regimen | Experimental | * 25% albumin infusion with monitoring of
* Hrly - MAP, HR, Urine output, Respiratory rate,SpO2 ,Temperature
* 3Hrly - POCUS, IVC Target <20 with respiratory phase variability, Lung USG with absence of B lines ,
* Daily - S.Cr, eGFR, Chest Xray, 2D Echo,Renal Resistive Index Receives: Biological: Albumin |
| Standard medical therapy | Active comparator | As defined in Revised consensus of International Club of Ascites and ADQI for AKI resolution Dosing of Albumin to be kept at 1gm/KG body weight daily
* Hrly - MAP, HR, Urine output, Respiratory rate,SpO2 ,Temperature
* 3Hrly - POCUS, IVC Target <20 with respiratory phase variability, Lung USG with absence of B lines ,
* Daily - S.Cr, eGFR, Chest Xray, 2D Echo,Renal Resistive Index, SOFA scoring Receives: Other: Standard Medical Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients having resolution of AKI at 48hrs or 7days without the development of adverse events
Measured: 48hrs/7days
Secondary outcomes (8)
Cumulative dose of albumin (in g/day) used in both arms at 48 hours and day 7
Measured: 48 hours and day 7
Time to initiation of vasoconstrictors and resolution of AKI
Measured: 7 days
Proportion of patients requiring invasive or non-invasive mechanical ventilation at 48 hours and at day7
Measured: 48 hours and day 7
Proportion of patients developing cardiopulmonary complications in both groups
Measured: 7 days
28-day mortality of hospitalized patients with AKI in Cirrhosis
Measured: 28 days
Proportion of patients with AKI progression or requiring dialysis at 48 hours and day 7
Measured: 48 hours and day 7
SOFA score changes at 48 hrs and 7 days
Measured: 48 hours and day 7
SIRS score changes at 48 hrs and 7 days
Measured: 48 hours and day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start31 Jan 2025 (estimated)
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 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
- NCT06809088
- Sponsor's protocol ID
- ILBS-AKI-04
- Status last verified
- Jan 2025
- First submitted
- 29 Jan 2025
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Safety and Efficacy of Tailored Versus Fixed Dose Albumin for the Management of Patients With Cirrhosis and Sepsis Associated Acute Kidney Injury - A Randomised Control Trial
- ClinicalTrials.gov ID
- NCT06809088
- Acronym / sponsor ID
- ILBS-AKI-04
- Conditions
- Liver Cirrhosis, Acute Kidney Injury
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 31 Jan 2025 (estimated)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 5 Feb 2025 (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 accompanies about 20% of hospitalized patients with cirrhosis and in about 40% of those admitted to ICU.A critically ill patient with cirrhosis refers to an individual who has advanced liver disease (cirrhosis) and is experiencing severe and potentially life-threatening complications that require intensive medical care and monitoring. These complications might include hepatic encephalopathy, acute liver failure, severe bleeding due to portal hypertension, or other organ failures. Such patients often require specialized medical attention and interventions to stabilize their condition. The short-term prognosis of cirrhotic patients with acute kidney injury is poor, with a mortality rate higher than 65% in patients with RRT requirement. Patients with cirrhosis are prone to develop AKI . HRS comprises specific form of AKI[HRS-AKI] in patients with advanced cirrhosis and ascites, carries a high mortality risk. Role of albumin as colloid serves both as volume supplement and also as additive to vasoconstrictors. Ascites, elevated bilirubin, spontaneous bacterial peritonitis [SBP] and use of amino glycosides antibiotics had previously been identified as significant risk factors for renal failure in cirrhotic patients. The causes of AKI in cirrhotic patients include HRS [most common], others include ATN [associated mostly with sepsis]and hypovolemic shock. Three month survival ranged from 73% in patients with parenchymatous AKI to 15% for HRS. As per 2023 joint meeting of ICA and ADQI ,based on baseline serum creatinine[sCr](a lowest value obtained within the previous 3 months),AKI is defined by an absolute increases of sCr>=0.3mg/dl within 48hr or a percentage increase of sCr>=50% from baseline within 7 days and urine output <= 0.5ml/kg for >=6hrs.As per KDIGO ,three stages of AKI are defined :Stage 1]when the previous criteria are met [a relative increase of sCr 1.5-2.0from baseline, stage 2]when increase in sCr is >2folds to 3 folds from baseline and Stage 3]when there is an increase of sCr>3 folds from baseline or sCr is >4.0mg/dl with an acute increase of >0.3mg/dl or initiation of RRT. So, the study aims to analyze the role of albumin as a volume supplement and as a vasoconstrictor as well as its immunomodulatory effect in sepsis to help in resolution of AKI.Here we compare the effectiveness of personalized-dose albumin administration with fixed-dose albumin for treating acute kidney injury in patients with cirrhosis and sepsis associated AKI.
Detailed description
Study population:
- Age - 18-70 years
Study design: Monocentric open label randomised controlled study. The study will be conducted in Department of Hepatology ILBS.
Primary Objective : Effect of personalized dose of albumin compared to fixed dose protocol in improving AKI resolution at 48 hrs.
Secondary objectives:
- To study the cumulative dose of albumin in both groups.
- Time to AKI resolution and initiation of vasoconstrictors in both the groups
- Incidence of cardiopulmonary complications in both groups
- Impact of dose of albumin on cardiac function [including CVP and IVC], intraabdominal pressure and renal perfusion [assessed by renal artery resistive index] in both groups at 24 hr and 48 hrs.
- To study the role of intraabdominal pressure, Lung USG , biomarkers of cardiac dysfunction [NT Pro BNP, Troponin T] in predicting the development of cardiopulmonary complications and AKI outcomes.
- To study the duration of AKI and need of dialysis in both groups.
- 28-day mortality in both groups
Stopping Rule:
- With the development of cardiorespiratory adverse effects
- Increase in Heart rate > 10 from basal value
- Increase in RR > 20/min
- Temp > 1000 F
- SpO2 < 96%
- B lines in Lung USG
- IVC >= 20 with collapsibility <50% or distensibilty <18%
- Development of allergy
- On worsening shock ,if Noradrenaline requirement increases >0.1mcg/kg bw/min
- worsening AKI with a]decrease in urine output b]Need of Terlipressin c]Start of RRT
- If Downstaging of AKI does not occur on 48hr of Albumin infusion then based on GFR and urine output decision to add vasoconstrictor to be taken
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized Regimen | Experimental | Biological: Albumin* 25% albumin infusion with monitoring of * Hrly - MAP, HR, Urine output, Respiratory rate,SpO2 ,Temperature * 3Hrly - POCUS, IVC Target <20 with respiratory phase variability, Lung USG with absence of B lines , * Daily - S.Cr, eGFR, Chest Xray, 2D Echo,Renal Resistive Index |
| Standard medical therapy | Active comparator | Other: Standard Medical TreatmentAs defined in Revised consensus of International Club of Ascites and ADQI for AKI resolution Dosing of Albumin to be kept at 1gm/KG body weight daily * Hrly - MAP, HR, Urine output, Respiratory rate,SpO2 ,Temperature * 3Hrly - POCUS, IVC Target <20 with respiratory phase variability, Lung USG with absence of B lines , * Daily - S.Cr, eGFR, Chest Xray, 2D Echo,Renal Resistive Index, SOFA scoring |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age >18 and <70
- patients with cirrhosis and AKI with sepsis.
Key exclusion criteria (14 listed)
- AKI- secondary to post renal causes such as nephrolithiasis
- Patient already on maintenance hemodialysis/RRT
- Patients with shock requiring vasopressors
- Patient with history of structural heart disease and LVEF < 50%
- Patient with known COPD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlbuminAlbumin | Biological | Personalized Regimen |
| Standard Medical TreatmentStandard Medical Treatment | Other | Standard medical therapy |
Primary outcome
Proportion of patients having resolution of AKI at 48hrs or 7days without the development of adverse events
Time frame: 48hrs/7days
8 secondary outcomes
Cumulative dose of albumin (in g/day) used in both arms at 48 hours and day 7
Time frame: 48 hours and day 7
Time to initiation of vasoconstrictors and resolution of AKI
Time frame: 7 days
Proportion of patients requiring invasive or non-invasive mechanical ventilation at 48 hours and at day7
Time frame: 48 hours and day 7
Proportion of patients developing cardiopulmonary complications in both groups
Time frame: 7 days
28-day mortality of hospitalized patients with AKI in Cirrhosis
Time frame: 28 days
Proportion of patients with AKI progression or requiring dialysis at 48 hours and day 7
Time frame: 48 hours and day 7
SOFA score changes at 48 hrs and 7 days
Time frame: 48 hours and day 7
SIRS score changes at 48 hrs and 7 days
Time frame: 48 hours and day 7
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 5 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Albumin and Standard Medical Treatment in people with Liver Cirrhosis and Acute Kidney Injury, 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 2 inclusion and 14 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: opening soon, as of the sponsor's last update on 5 Feb 2025. 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 Shreyas Sarvesh, MD (01146300000, shreyassarvesh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients having resolution of AKI at 48hrs or 7days without the development of adverse events (time frame: 48hrs/7days). 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 5 Feb 2025.