Health Condition 1: K77- Liver disorders in diseases classified elsewhere
Conditions
Interventions
Control Intervention1: Group 1: 5% Albumin: Resuscitation Fluid
Control Intervention2: Group 2: Plasmalyte: Resuscitation fluid
Sponsors
Post Graduate Medical Education and Research Chandigarh
Eligibility
Inclusion criteria
Inclusion criteria: 1) Adults ( >18 years) admitted to ICU with cirrhosis and sepsis 2) Hypotension (Mean Arterial Pressure (MAP) 3) Lactate levels >2 mmol/L (to pick even mild hypoperfusion) 4) Clinical need for of a Central Venous Catheter (CVC) and arterial line
Exclusion criteria
Exclusion criteria: 1) Severe pre-existing cardiopulmonary disease 2) Active bleeding 3) Cerebrovascular events 4) Prior renal disease/need of renal replacement therapy 5) Admission to ICU following liver transplantation, burns, cardiac surgery 6) Brain death or likely brain death within 24 hours 7) Previous adverse reaction to human albumin solution
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcomes: (A) Major Adverse Kidney Events within 30 days (MAKE30), the composite of persistent renal dysfunction, new renal replacement therapy (RRT), and in-hospital mortality in the 5% Albumin versus Plasmalyte group.Timepoint: Baseline, 7 days, 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| duration of stay in the ICU, hospital stay, ventilator dependence, SOFA score, Incidence of AKI, dialysis requirement, duration of dialysis dependence, change in urinary biomarkers of AKI (including cystatin C, interleukin-18 (IL-18), kidney injury molecule-1 (KIM-1), liver-type fatty acid-binding protein (L-FABP), and neutrophil gelatinase-associated lipocalin(NGAL), metalloproteinase 2 (TIMP-2) and insulin-like growth factorââ?¬â??binding protein 7 (IGFBP7)), Change in BNP , aldosterone and PRATimepoint: 30 days | — |
Countries
India
Contacts
Public ContactSmita Divyaveer
Department of Nephrology, Post Graduate Medical Education and Research, Chandigarh.
Outcome results
None listed