High-Volume Plasma Exchange Versus Standard Medical Treatment in Patients With Acute Liver Failure
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ClinicalTrials.gov Identifier: NCT02718079 |
Recruitment Status :
Completed
First Posted : March 24, 2016
Last Update Posted : November 20, 2019
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Condition or disease | Intervention/treatment | Phase |
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Acute Liver Failure | Biological: Plasma Exchange Other: Management of cerebral edema/intracranial hypertension: Other: Transfer to Intensive Care Unit Drug: Prophylactic Antibiotics Other: Intubation of trachea Other: Administration of mannitol or 3% saline for severe elevation of Intra Cranial Pressure Other: Volume Replacement Other: Pressor Support Drug: N-acetyl-L-cysteine Other: Correction of metabolic parameters Dietary Supplement: Correction of nutrition | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | High-Volume Plasma Exchange Versus Standard Medical Treatment in Patients With Acute Liver Failure-A Prospective Randomized Pilot Trial |
Actual Study Start Date : | December 30, 2016 |
Actual Primary Completion Date : | October 8, 2018 |
Actual Study Completion Date : | October 18, 2018 |
Arm | Intervention/treatment |
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Experimental: Standard medical therapy with Plasma Exchange
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.
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Biological: Plasma Exchange Other: Management of cerebral edema/intracranial hypertension: Other: Transfer to Intensive Care Unit Drug: Prophylactic Antibiotics Other: Intubation of trachea Other: Administration of mannitol or 3% saline for severe elevation of Intra Cranial Pressure Other: Volume Replacement Other: Pressor Support Drug: N-acetyl-L-cysteine Other: Correction of metabolic parameters Dietary Supplement: Correction of nutrition |
Active Comparator: Standard medical therapy alone
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.
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Other: Management of cerebral edema/intracranial hypertension: Other: Transfer to Intensive Care Unit Drug: Prophylactic Antibiotics Other: Intubation of trachea Other: Administration of mannitol or 3% saline for severe elevation of Intra Cranial Pressure Other: Volume Replacement Other: Pressor Support Drug: N-acetyl-L-cysteine Other: Correction of metabolic parameters Dietary Supplement: Correction of nutrition |
- Survival in both groups. [ Time Frame: 21 days ]
- Duration of Intensive Care Unit stay in both groups. [ Time Frame: 21 days ]
- Improvement in SIRS (Systemic Inflammatory Response Syndrome) score. [ Time Frame: 48 hours ]
- Improvement in SIRS (Systemic Inflammatory Response Syndrome) score. [ Time Frame: day 5 ]
- Improvement in SIRS (Systemic Inflammatory Response Syndrome) score. [ Time Frame: day 7 ]
- Improvement in SOFA (Sequential Organ Failure Assessment) score. [ Time Frame: 48 hours ]
- Improvement in SOFA (Sequential Organ Failure Assessment) score. [ Time Frame: day 5 ]
- Improvement in SOFA (Sequential Organ Failure Assessment) score. [ Time Frame: day 7 ]
- Improvement in APACHE II (Acute Physiology and Chronic Health Evaluation) score. [ Time Frame: 48 hours ]
- Improvement in APACHE II (Acute Physiology and Chronic Health Evaluation) score. [ Time Frame: Day 5 ]
- Improvement in APACHE II (Acute Physiology and Chronic Health Evaluation) score. [ Time Frame: Day 7 ]
- Effect on systemic haemodynamics in both groups. [ Time Frame: 24 hours ]Effect is defined as resolution of SIRS (Systemic Inflammatory Response Syndrome).
- Effect on systemic haemodynamics in both groups. [ Time Frame: 48 hours ]Effect is defined as resolution of SIRS (Systemic Inflammatory Response Syndrome).
- Pro inflammatory cytokines profile in both groups. [ Time Frame: 1 hour ]
- Serum Endotoxin levels in both groups. [ Time Frame: 1 hour ]

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Ages Eligible for Study: | 12 Years to 75 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with acute liver failure defined as : Patients with jaundice which is complicated by encephalopathy and coagulopathy within 4 weeks of the onset of jaundice and without underlying chronic liver disease.
Exclusion Criteria:
- Age <12 or > 75 years
- Hepato-Cellular Carcinoma
- Active untreated Sepsis/DIC
- Any evidence of active bleed secondary to coagulopathy
- Hemodynamic instability requiring high dose of Vasopressors
- Coma of non-hepatic origin.
- Pregnancy
- Comorbidities associated with poor outcome (Extrahepatic neoplasia, severe cardiopulmonary disease defined by a New York Heart Association score >3, or oxygen/steroid-dependent chronic obstructive pulmonary disease).
- Patients being taken up for liver transplant
- Refusal to participate in the study.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02718079
India | |
Institute of liver and Biliary Sciences | |
New Delhi, Delhi, India, 110070 |
Principal Investigator: | Dr Rakhi Maiwall, DM | Institute of Liver and Biliary Sciences |
Responsible Party: | Institute of Liver and Biliary Sciences, India |
ClinicalTrials.gov Identifier: | NCT02718079 |
Other Study ID Numbers: |
ILBS-ALF-03 |
First Posted: | March 24, 2016 Key Record Dates |
Last Update Posted: | November 20, 2019 |
Last Verified: | November 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Liver Failure Hepatic Insufficiency Liver Failure, Acute Liver Diseases Digestive System Diseases Anti-Bacterial Agents Acetylcysteine Mannitol N-monoacetylcystine Anti-Infective Agents Diuretics, Osmotic |
Diuretics Natriuretic Agents Physiological Effects of Drugs Antiviral Agents Expectorants Respiratory System Agents Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Antidotes |