Impact of fluids on kidney outcomes in critically ill cirrhotic patients with sepsis
Not Applicable
- Conditions
- Health Condition 1: K77- Liver disorders in diseases classified elsewhere
- Registration Number
- CTRI/2020/05/025064
- Lead Sponsor
- Post Graduate Medical Education and Research Chandigarh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1)Adults ( >18 years) admitted to ICU with cirrhosis and sepsis
2)Hypotension (Mean Arterial Pressure (MAP) <65mmHg)
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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