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Patients with cirrhosis patients have a high incidence of sepsis which can trigger decompensation and may result in prolonged hospital stay and increased mortality. About 30%-50% admissions of patients with cirrhosis have sepsis at presentation and about 15% patients admitted to hospital develop sepsis during the hospital stay . After infection develops, the patient may develop acute kidney injury (AKI), shock, encephalopathy or disseminated intravascular coagulation (DIC) further decreasing the chances of survival. In fact, sepsis in patients with cirrhosis is associated with 15% in-hospital mortality, approximately double that of patients without sepsis. So, sepsis is directly responsible for 30-50% of deaths in cirrhosis . Therefore, it is critical to manage sepsis early and appropriately in cirrhosis to reduce the complications and mortality. Early administration of fluids, source control and empirical antibiotics along with vasopressors if refractory shock are essential components of treatment in all patients with sepsis. Currently, the most accepted strategy for early sepsis management is a combination of early goal directed therapy (EGDT) and physiological parameters, such as urine output, lactate clearance, and administration of antibiotics, within 1 hour of presentation . The use of central venous pressure assessment is fallacious for gauging adequacy of fluid resuscitation in cirrhosis, and the difficulty of performing echocardiographic assessments in the setting of ascites and cirrhotic cardiomyopathy is also well described .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 20% Albumin arm | Experimental | 20% Albumin in a dose of 20-40 gm per day as infusion over 12-24 h |
|
| Balanced salt solution arm | Active Comparator | Fluid resuscitation protocol includes use of an immediate 500 ml bolus of crystalloid i.e., balanced salt solution (BSS) or 0.9% normal saline (Rescue phase), followed by 20 ml/kg fluid in the first 6 hours titrated to target MAP of > 65mmHg.The second phase of fluid resuscitation (Optimization phase) will be performed as per IVC targets, attainment of lactate clearance, and LUS score to prevent overload. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 20% albumin | Drug | Albumin arm for resuscitation fluid |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the efficacy of 20% Albumin vs Plasmalyte in the first 3 -6 hours of volume resuscitation in cirrhosis with sepsis induced hypotension and assess IVC dynamics. | To compare the IVC dynamics in patients with cirrhosis and sepsis induced hypotension | At enrolment |
| To compare the efficacy of 20% Albumin vs Plasmalyte in the first 3 -6 hours of volume resuscitation in cirrhosis with sepsis induced hypotension and assess IVC dynamics. | To compare the IVC dynamics in patients with cirrhosis and sepsis induced hypotension | At 6 hours |
| To compare the efficacy of 20% Albumin vs Plasmalyte in the first 3 -6 hours of volume resuscitation in cirrhosis with sepsis induced hypotension and assess IVC dynamics. | To compare the IVC dynamics in patients with cirrhosis and sepsis induced hypotension | At 24 hours |
| To compare the efficacy of 20% Albumin vs Plasmalyte in the first 3 -6 hours of volume resuscitation in cirrhosis with sepsis induced hypotension and assess IVC dynamics. | To compare the IVC dynamics in patients with cirrhosis and sepsis induced hypotension | At 48 hours. |
| To compare the efficacy of 20% Albumin vs Plasmalyte in the first 3 -6 hours of volume resuscitation in cirrhosis with sepsis induced hypotension and assess dynamic changes in cardiac output, stroke volume and E/e' echocardiographic parameters. | To compare the cardiac output in patients with cirrhosis and sepsis induced hypotension | At enrolment |
| To compare the efficacy of 20% Albumin vs Plasmalyte in the first 3 -6 hours of volume resuscitation in cirrhosis with sepsis induced hypotension and assess dynamic changes in cardiac output, stroke volume and E/e' echocardiographic parameters. |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary marker of AKI (NGal) | At enrolment | |
| Change in urinary markers of AKI (NGal) | At 24 hours. | |
| Change in urinary markers of AKI(NGal) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Madhumita Premkumar, DM | Contact | 01722756344 | drmadhumitap@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Postgraduate Institute of Medical Education and Research | Recruiting | Chandigarh | 160012 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11303974 | Background | Borzio M, Salerno F, Piantoni L, Cazzaniga M, Angeli P, Bissoli F, Boccia S, Colloredo-Mels G, Corigliano P, Fornaciari G, Marenco G, Pistara R, Salvagnini M, Sangiovanni A. Bacterial infection in patients with advanced cirrhosis: a multicentre prospective study. Dig Liver Dis. 2001 Jan-Feb;33(1):41-8. doi: 10.1016/s1590-8658(01)80134-1. | |
| 10604106 |
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| Balanced salt solution |
| Drug |
Only Balanced salt solution will be used. |
|
To compare the cardiac output in patients with cirrhosis and sepsis induced hypotension |
| At 24 hours |
| To compare the efficacy of 20% Albumin vs Plasmalyte in the first 3 -6 hours of volume resuscitation in cirrhosis with sepsis induced hypotension and assess dynamic changes in cardiac output, stroke volume and E/e' echocardiographic parameters. | To compare the cardiac output in patients with cirrhosis and sepsis induced hypotension | At 48 hours. |
| To compare the efficacy of 20% Albumin vs Plasmalyte in the first 3 -6 hours of volume resuscitation in cirrhosis with sepsis induced hypotension and assess new onset of hepatorenal syndrome (HRS) or acute kidney injury (AKI) | To compare the new onset of hepatorenal syndrome (HRS) or acute kidney injury (AKI)in patients with cirrhosis and sepsis induced hypotension | At enrolment |
| To compare the efficacy of 20% Albumin vs Plasmalyte in the first 3 -6 hours of volume resuscitation in cirrhosis with sepsis induced hypotension and assess new onset of hepatorenal syndrome (HRS) or acute kidney injury (AKI) | To compare the new onset of hepatorenal syndrome (HRS) or acute kidney injury (AKI)in patients with cirrhosis and sepsis induced hypotension | At 48 hours. |
| At 48 hours. |
| To compare the efficacy of 20% Albumin vs Plasmalyte in the first 3 -6 hours of volume resuscitation in cirrhosis with sepsis induced hypotension., and assess vasopressor requirement | To compare the vasopressor requirement in patients with cirrhosis and sepsis induced hypotension | At enrolment |
| To compare the efficacy of 20% Albumin vs Plasmalyte in the first 3 -6 hours of volume resuscitation in cirrhosis with sepsis induced hypotension., and assess vasopressor requirement | To compare the vasopressor requirement in patients with cirrhosis and sepsis induced hypotension | At 24 hours |
| Navasa M, Fernandez J, Rodes J. Bacterial infections in liver cirrhosis. Ital J Gastroenterol Hepatol. 1999 Oct;31(7):616-25. |
| 15831923 | Background | Wong F, Bernardi M, Balk R, Christman B, Moreau R, Garcia-Tsao G, Patch D, Soriano G, Hoefs J, Navasa M; International Ascites Club. Sepsis in cirrhosis: report on the 7th meeting of the International Ascites Club. Gut. 2005 May;54(5):718-25. doi: 10.1136/gut.2004.038679. |
| 1597026 | Background | Moreau R, Hadengue A, Soupison T, Kirstetter P, Mamzer MF, Vanjak D, Vauquelin P, Assous M, Sicot C. Septic shock in patients with cirrhosis: hemodynamic and metabolic characteristics and intensive care unit outcome. Crit Care Med. 1992 Jun;20(6):746-50. doi: 10.1097/00003246-199206000-00008. |
| 25272316 | Background | ARISE Investigators; ANZICS Clinical Trials Group; Peake SL, Delaney A, Bailey M, Bellomo R, Cameron PA, Cooper DJ, Higgins AM, Holdgate A, Howe BD, Webb SA, Williams P. Goal-directed resuscitation for patients with early septic shock. N Engl J Med. 2014 Oct 16;371(16):1496-506. doi: 10.1056/NEJMoa1404380. Epub 2014 Oct 1. |
| 25776532 | Background | Mouncey PR, Osborn TM, Power GS, Harrison DA, Sadique MZ, Grieve RD, Jahan R, Harvey SE, Bell D, Bion JF, Coats TJ, Singer M, Young JD, Rowan KM; ProMISe Trial Investigators. Trial of early, goal-directed resuscitation for septic shock. N Engl J Med. 2015 Apr 2;372(14):1301-11. doi: 10.1056/NEJMoa1500896. Epub 2015 Mar 17. |
| 18628220 | Background | Marik PE, Baram M, Vahid B. Does central venous pressure predict fluid responsiveness? A systematic review of the literature and the tale of seven mares. Chest. 2008 Jul;134(1):172-8. doi: 10.1378/chest.07-2331. |
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D065290 | Acute-On-Chronic Liver Failure |
| D012772 | Shock, Septic |
| D012769 | Shock |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017114 | Liver Failure, Acute |
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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| ID | Term |
|---|---|
| D000418 | Albumins |
| C072670 | Hanks Balanced Salt Solution |
| ID | Term |
|---|---|
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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