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Consecutive cirrhotics who present to emergency department of Institute of Liver & Biliary Sciences with documented or suspected sepsis induced hypotension will be randomized to receive either human albumin infusion over 3 hours or plasmalyte as per requirement. At admission, all patients will undergo physical examination and baseline investigations to identify site of sepsis. The aim of study is to compare the efficacy of using 20% human albumin versus plasmalyte in resuscitation of the patient that is attainment of mean arterial pressure above 65 mm of Hg at three hour after intervention and sustenance of mean arterial pressure above 65 mm of Hg at 6th hour. The randomized patient will be administered 20% albumin (0.5-1.0 gm/kg) for 3 hours, or plasmalyte at the rate of 30ml/kg. After the intervention changes in MAP (Mean Arterial Pressure), lactate level, urine output, incidence of complications, duration of ventilator, ICU (Intensive Care Unit) stay and mortality after one week will be studied.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resuscitation with 30ml/kg plasmalyte | Active Comparator |
| |
| Resuscitation with 20% Albumin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 20% Albumin | Biological |
| ||
| Plasmalyte |
| Measure | Description | Time Frame |
|---|---|---|
| Reversal of hypotension in both groups | Reversal is defined as Mean Arterial Pressure (MAP) > 65 mmHg after 3 hours of resuscitation | 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality in both groups | 7 days | |
| Survival time during the first 28 days | 28 days | |
| Proportion of patients with new organ failures. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Abhinav Verma, MD | Institute of Liver and Biliary Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Liver & Biliary Sciences | New Delhi | National Capital Territory of Delhi | 110070 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35460725 | Derived | Maiwall R, Kumar A, Pasupuleti SSR, Hidam AK, Tevethia H, Kumar G, Sahney A, Mitra LG, Sarin SK. A randomized-controlled trial comparing 20% albumin to plasmalyte in patients with cirrhosis and sepsis-induced hypotension [ALPS trial]. J Hepatol. 2022 Sep;77(3):670-682. doi: 10.1016/j.jhep.2022.03.043. Epub 2022 Apr 20. |
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|
| 28 days |
| Duration of mechanical ventilation. | 28 days |
| Requirement of renal-replacement therapy. | Renal-replacement therapy. is defined as patients who required hemodialysis , SLED (Sustained Low efficiency Dialysis) or CRRT (Continous renal replacement therapy). | 28 days |
| The duration of the Intensive Care Unit stay. | 28 days |
| ID | Term |
|---|---|
| D000418 | Albumins |
| C048013 | Plasmalyte A |
| ID | Term |
|---|---|
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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