High-Volume Plasma Exchange Versus Standard Medical Treatment in Patients With Acute Liver Failure
NCT ID: NCT02718079
Last Updated: 2019-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2016-12-30
2018-10-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Plasma Exchange
Management of cerebral edema/intracranial hypertension:
Transfer to Intensive Care Unit
Prophylactic Antibiotics
Intubation of trachea
Administration of mannitol or 3% saline for severe elevation of Intra Cranial Pressure
Volume Replacement
Pressor Support
N-acetyl-L-cysteine
Correction of metabolic parameters
Correction of nutrition
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.
Management of cerebral edema/intracranial hypertension:
Transfer to Intensive Care Unit
Prophylactic Antibiotics
Intubation of trachea
Administration of mannitol or 3% saline for severe elevation of Intra Cranial Pressure
Volume Replacement
Pressor Support
N-acetyl-L-cysteine
Correction of metabolic parameters
Correction of nutrition
Interventions
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Plasma Exchange
Management of cerebral edema/intracranial hypertension:
Transfer to Intensive Care Unit
Prophylactic Antibiotics
Intubation of trachea
Administration of mannitol or 3% saline for severe elevation of Intra Cranial Pressure
Volume Replacement
Pressor Support
N-acetyl-L-cysteine
Correction of metabolic parameters
Correction of nutrition
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
12 Years
75 Years
ALL
No
Sponsors
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Institute of Liver and Biliary Sciences, India
OTHER
Responsible Party
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Principal Investigators
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Dr Rakhi Maiwall, DM
Role: PRINCIPAL_INVESTIGATOR
Institute of Liver and Biliary Sciences
Locations
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Institute of liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
Countries
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References
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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.
Other Identifiers
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ILBS-ALF-03
Identifier Type: -
Identifier Source: org_study_id
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