An interventional study of Albumin and Standard Medical Treatment in Liver Cirrhosis and Acute Kidney Injury, sponsored by Institute of Liver and Biliary Sciences, India. Not yet recruiting at 1 site in India. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-02-05.
Sponsored by Institute of Liver and Biliary Sciences, India · Not applicable, Interventional, and Treatment
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:
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
1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.
This study's planned enrollment of 100 is above the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →Institute of Liver and Biliary Sciences, India is the lead sponsor of 296 studies on the registry; 84 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
* 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
Biological: Albumin
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
Other: Standard Medical Treatment
Albumin
Standard Medical Treatment
Proportion of patients having resolution of AKI at 48hrs or 7days without the development of adverse events
Time frame: 48hrs/7days
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
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Institute of Liver and Biliary Sciences, India