Cirrhosis With Septic Shock
Conditions
Brief summary
300 consecutive patients with cirrhosis of any aetiology admitted with features of sepsis and sepsis induced hypotension to the intensive care unit, the emergency department and the step down units of Institute of Liver and Biliary Sciences, New Delhi, who fulfil the inclusion criteria. This study will be a single centre prospective randomized comparative trial. Patients will be randomized into two groups. Group A will receive crystalloid, 0.9% sodium chloride solution (total of 30ml/kg over 30 minutes) and Group B will receive colloid, 5% albumin (250 ml over 15 minutes).
Interventions
DRUG5% albumin Infusion
colloid, 5% albumin (250 ml over 15 to 30 minutes).
0.9% sodium chloride solution (total of 30ml/kg over 15 to 30 minutes)
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Cirrhotic patients of any aetiology with Infection - suspected or documented and Mean arterial pressure less than 65 mm of Hg
Exclusion criteria
1. Cirrhosis patients in septic shock who are already on vasopressors and/or inotropes 2. Cirrhosis patients in septic shock with structural heart disease 3. Cirrhosis patients in septic shock with chronic renal failure/dialysis dependent/volume overloaded state 4. Cirrhosis patients in shock, caused by other reasons, other than septic shock 5. Cirrhosis patients in septic shock in whom contraindication to internal jugular or subclavian line insertion is present 6. Age less than 18 years 7. Previous episode of septic shock during the same hospital stay 8. Pregnant or lactating women 9. Patients in need for emergent surgical interventions 10. Cirrhosis patients in septic shock with chronic obstructive lung disease and right heart failure 11. Cirrhosis patients in septic shock with associated upper gastrointestinal bleed or coagulopathy related bleed with a haemoglobin of less than 8g/dL or requiring urgent transfusions of blood and blood products 12. A previous adverse reaction to human albumin solution
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total number of patients with MAP (Mean Arterial Pressure) ≥ 65 | 3 hours |
Secondary
| Measure | Time frame |
|---|---|
| Change in lactate dynamics | 3 hours |
| Total number of patients with Urine output >/= 0.5mL/kg/hr. | 3 hours |
| Mortality | 7 days |
Countries
India
Outcome results
None listed