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High-Volume Plasma Exchange Versus Standard Medical Treatment in Patients With Acute Liver Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02718079
Recruitment Status : Completed
First Posted : March 24, 2016
Last Update Posted : November 20, 2019
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
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

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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
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.
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.
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



Primary Outcome Measures :
  1. Survival in both groups. [ Time Frame: 21 days ]

Secondary Outcome Measures :
  1. Duration of Intensive Care Unit stay in both groups. [ Time Frame: 21 days ]
  2. Improvement in SIRS (Systemic Inflammatory Response Syndrome) score. [ Time Frame: 48 hours ]
  3. Improvement in SIRS (Systemic Inflammatory Response Syndrome) score. [ Time Frame: day 5 ]
  4. Improvement in SIRS (Systemic Inflammatory Response Syndrome) score. [ Time Frame: day 7 ]
  5. Improvement in SOFA (Sequential Organ Failure Assessment) score. [ Time Frame: 48 hours ]
  6. Improvement in SOFA (Sequential Organ Failure Assessment) score. [ Time Frame: day 5 ]
  7. Improvement in SOFA (Sequential Organ Failure Assessment) score. [ Time Frame: day 7 ]
  8. Improvement in APACHE II (Acute Physiology and Chronic Health Evaluation) score. [ Time Frame: 48 hours ]
  9. Improvement in APACHE II (Acute Physiology and Chronic Health Evaluation) score. [ Time Frame: Day 5 ]
  10. Improvement in APACHE II (Acute Physiology and Chronic Health Evaluation) score. [ Time Frame: Day 7 ]
  11. Effect on systemic haemodynamics in both groups. [ Time Frame: 24 hours ]
    Effect is defined as resolution of SIRS (Systemic Inflammatory Response Syndrome).

  12. Effect on systemic haemodynamics in both groups. [ Time Frame: 48 hours ]
    Effect is defined as resolution of SIRS (Systemic Inflammatory Response Syndrome).

  13. Pro inflammatory cytokines profile in both groups. [ Time Frame: 1 hour ]
  14. Serum Endotoxin levels in both groups. [ Time Frame: 1 hour ]


Information from the National Library of Medicine

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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
Criteria

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.

Information from the National Library of Medicine

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


Locations
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India
Institute of liver and Biliary Sciences
New Delhi, Delhi, India, 110070
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
Investigators
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Principal Investigator: Dr Rakhi Maiwall, DM Institute of Liver and Biliary Sciences
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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
Additional relevant MeSH terms:
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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