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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5% albumin Infusion | Experimental | (250 ml over 15 to 30 minutes) |
|
| 0.9% sodium chloride solution | Active Comparator | 0.9% sodium chloride solution (total of 30ml/kg over 15 to 30 minute) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5% albumin Infusion | Drug | colloid, 5% albumin (250 ml over 15 to 30 minutes). |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of patients with MAP (Mean Arterial Pressure) ≥ 65 | 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change in lactate dynamics | 3 hours | |
| Total number of patients with Urine output >/= 0.5mL/kg/hr. | 3 hours | |
| Mortality |
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Inclusion Criteria:
Exclusion Criteria:
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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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| 0.9% sodium chloride solution |
| Drug |
0.9% sodium chloride solution (total of 30ml/kg over 15 to 30 minutes) |
|
| 7 days |
| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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