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The study will be conducted on patients admitted to Department of Hepatology from Jan 2016 to Jan 2018 at Institute of Liver & Biliary Sciences, New Delhi. Study group will comprise of patients with acute liver failure (ALF) who have no option for liver transplant (due to any reason) or have contraindications for liver transplant or have no prospective living donor and will be assessed for enrollment in the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard medical therapy with Plasma Exchange | Experimental | Plasma Exchange will be performed for consecutive days. Standard medical therapy included as per requirement,management of cerebral edema/intracranial hypertension: transfer to ICU,prophylactic antibiotics, intubation of trachea (as required),administration of mannitol or 3% saline for severe elevation of Intra Cranial Pressure,volume replacement and pressor support (norepinephrine, vasopressin) as needed, NAC, correction of metabolic parameters and nutrition. |
|
| Standard medical therapy alone | Active Comparator | Standard medical therapy included as per requirement,management of cerebral edema/intracranial hypertension: transfer to ICU,prophylactic antibiotics, intubation of trachea (as required),administration of mannitol or 3% saline for severe elevation of Intra Cranial Pressure,volume replacement and pressor support (norepinephrine, vasopressin) as needed, NAC, correction of metabolic parameters and nutrition. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plasma Exchange | Biological |
| ||
| Management of cerebral edema/intracranial hypertension: |
| Measure | Description | Time Frame |
|---|---|---|
| Survival in both groups. | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Intensive Care Unit stay in both groups. | 21 days | |
| Improvement in SIRS (Systemic Inflammatory Response Syndrome) score. | 48 hours | |
| Improvement in SIRS (Systemic Inflammatory Response Syndrome) score. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Rakhi Maiwall, DM | Institute of Liver and Biliary Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of liver and Biliary Sciences | New Delhi | National Capital Territory of Delhi | 110070 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33524593 | Derived | Maiwall R, Bajpai M, Singh A, Agarwal T, Kumar G, Bharadwaj A, Nautiyal N, Tevethia H, Jagdish RK, Vijayaraghavan R, Choudhury A, Mathur RP, Hidam A, Pati NT, Sharma MK, Kumar A, Sarin SK. Standard-Volume Plasma Exchange Improves Outcomes in Patients With Acute Liver Failure: A Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2022 Apr;20(4):e831-e854. doi: 10.1016/j.cgh.2021.01.036. Epub 2021 Jan 29. |
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| Other |
|
| Transfer to Intensive Care Unit | Other |
|
| Prophylactic Antibiotics | Drug |
|
| Intubation of trachea | Other |
|
| Administration of mannitol or 3% saline for severe elevation of Intra Cranial Pressure | Other |
|
| Volume Replacement | Other |
|
| Pressor Support | Other |
|
| N-acetyl-L-cysteine | Drug |
|
| Correction of metabolic parameters | Other |
|
| Correction of nutrition | Dietary Supplement |
|
| day 5 |
| Improvement in SIRS (Systemic Inflammatory Response Syndrome) score. | day 7 |
| Improvement in SOFA (Sequential Organ Failure Assessment) score. | 48 hours |
| Improvement in SOFA (Sequential Organ Failure Assessment) score. | day 5 |
| Improvement in SOFA (Sequential Organ Failure Assessment) score. | day 7 |
| Improvement in APACHE II (Acute Physiology and Chronic Health Evaluation) score. | 48 hours |
| Improvement in APACHE II (Acute Physiology and Chronic Health Evaluation) score. | Day 5 |
| Improvement in APACHE II (Acute Physiology and Chronic Health Evaluation) score. | Day 7 |
| Effect on systemic haemodynamics in both groups. | Effect is defined as resolution of SIRS (Systemic Inflammatory Response Syndrome). | 24 hours |
| Effect on systemic haemodynamics in both groups. | Effect is defined as resolution of SIRS (Systemic Inflammatory Response Syndrome). | 48 hours |
| Pro inflammatory cytokines profile in both groups. | 1 hour |
| Serum Endotoxin levels in both groups. | 1 hour |
| ID | Term |
|---|---|
| D017114 | Liver Failure, Acute |
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D010951 | Plasma Exchange |
| D007442 | Intubation, Intratracheal |
| D012965 | Sodium Chloride |
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D001803 | Blood Transfusion |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D010956 | Plasmapheresis |
| D001781 | Blood Component Removal |
| D016060 | Sorption Detoxification |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |
| D058109 | Airway Management |
| D007440 | Intubation |
| D008919 | Investigative Techniques |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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