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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.
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:
Stopping Rule:
With the development of cardiorespiratory adverse effects
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personalized Regimen | Experimental |
|
|
| 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
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albumin | Biological | Albumin |
| |
| Standard Medical Treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients having resolution of AKI at 48hrs or 7days without the development of adverse events | 48hrs/7days |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative dose of albumin (in g/day) used in both arms at 48 hours and day 7 | 48 hours and day 7 | |
| Time to initiation of vasoconstrictors and resolution of AKI | 7 days | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Shreyas Sarvesh, MD | Contact | 01146300000 | shreyassarvesh@gmail.com | |
| Dr Rakhi Maiwall, DM | Contact | 01146300000 | rakhi_2011@yahoo.co.in |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of liver and Biliary Sciences | New Delhi | National Capital Territory of Delhi | 110070 | India |
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| Other |
Standard Medical Treatment |
|
| Proportion of patients requiring invasive or non-invasive mechanical ventilation at 48 hours and at day7 |
| 48 hours and day 7 |
| Proportion of patients developing cardiopulmonary complications in both groups | 7 days |
| 28-day mortality of hospitalized patients with AKI in Cirrhosis | 28 days |
| Proportion of patients with AKI progression or requiring dialysis at 48 hours and day 7 | 48 hours and day 7 |
| SOFA score changes at 48 hrs and 7 days | 48 hours and day 7 |
| SIRS score changes at 48 hrs and 7 days | 48 hours and day 7 |
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000418 | Albumins |
| ID | Term |
|---|---|
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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