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Consecutive patients with ACLF (Acute on Chronic Liver Failure) and septic shock with AKI (Acute Kidney Injury) who give written informed consent will be included in this prospective trial at ILBS. At baseline s, endotoxin levels, NT-Pro BNP, , urine N-GAL will be done for all patients. A 10 ml serum sample will be stored for doing a cytokine profile. Septic shock will be defined by the presence of two or more diagnostic criteria for the systemic inflammatory response syndrome, proven or suspected infection with hypotension non-responsive to adequate fluid resuscitation assessed by no evidence of stroke volume variation on flow track and need of a vasopressor to achieve a target mean arterial pressure (MAP) of ≥ 65 mm Hg. A record of CVP, IVC diameter and B-lines on ultrasound lung would also be done. Patients with age less than 18 years, severe known cardiopulmonary disease (structural or valvular heart disease, coronary artery disease, COPD) pregnancy, chronic kidney disease, patients already meeting emergency criteria for immediate hemodialysis at the time of randomization as specified in the late group, patients transferred from other hospitals who have already been on hemodialysis before their arrival in the intensive care unit, extremely moribund patients with an expected life expectancy of less than 24 hours, failure to give informed consent from family members.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early CRRT | Experimental | Early Continous Renal Replacement Therapy within 6 hours + Standard Medical Therapy |
|
| Late CRRT | Active Comparator | Late Continous Renal Replacement Therapy + Standard Medical Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early CRRT | Other | Continous Renal Replacement Therapy |
| |
| Late CRRT |
| Measure | Description | Time Frame |
|---|---|---|
| Transplant Free Survival | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of intradialytic hypotension i.e. defined as a decrease in systolic blood pressure by ≥20 mm Hg or a decrease in MAP by 10 mm Hg associated with symptoms | 1 year | |
| Hemodynamic stability i.e. maintenance of MAP on dialysis without increase in the vasopressors |
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Inclusion Criteria:
- Patients with ACLF defined based on APASL criteria with septic shock associated AKI
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Rakhi Maiwall, MD,DM | Contact | 01146300000 | rakhi_2011@yahoo.co.in |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Liver and Biliary Sciences | Recruiting | New Delhi | National Capital Territory of Delhi | 110070 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36416787 | Derived | Fayad AI, Buamscha DG, Ciapponi A. Timing of kidney replacement therapy initiation for acute kidney injury. Cochrane Database Syst Rev. 2022 Nov 23;11(11):CD010612. doi: 10.1002/14651858.CD010612.pub3. |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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| Other |
Continous Renal Replacement Therapy |
|
| Standard Medical Therapy | Other | Standard Medical Therapy |
|
| 1 year |
| Dialysis efficiency as measured by Urea Reduction ratio at 48 hours | 2 days |
| Achievement of target ultrafiltration goals | 1 year |
| Recovery in renal functions defined as an increase in urine output to more than 400 ml/day | 1 year |
| Duration of mechanical ventilation and ICU (Intensive Care Unit) stay | 1 year |
| Improvement in SOFA (Sequential Organ Failure Assessment ) ( by 2 points) scores | 1 year |
| Improvement in APACHE (Acute Physiology and Chronic Health Evaluation) ( by 2 points) scores | 1 year |
| Improvement in MELD (Model for End Stage Liver Disease) ( by 2 points) scores | 1 year |
| Improvement in lactic acidosis and lactate clearance at 6 hours after initiation of CRRT | within 6 hours |
| Improvement in lactic acidosis and lactate clearance at 12 hours after initiation of CRRT | within 12 hours |
| Improvement in lactic acidosis and lactate clearance at 24 hours after initiation of CRRT | within 24 hours |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |