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

Primary Purpose

Acute Liver Failure

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
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
Sponsored by
Institute of Liver and Biliary Sciences, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Liver Failure

Eligibility Criteria

12 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institute of liver and Biliary Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Standard medical therapy with Plasma Exchange

Standard medical therapy alone

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Survival in both groups.

Secondary Outcome Measures

Duration of Intensive Care Unit stay in both groups.
Improvement in SIRS (Systemic Inflammatory Response Syndrome) score.
Improvement in SIRS (Systemic Inflammatory Response Syndrome) score.
Improvement in SIRS (Systemic Inflammatory Response Syndrome) score.
Improvement in SOFA (Sequential Organ Failure Assessment) score.
Improvement in SOFA (Sequential Organ Failure Assessment) score.
Improvement in SOFA (Sequential Organ Failure Assessment) score.
Improvement in APACHE II (Acute Physiology and Chronic Health Evaluation) score.
Improvement in APACHE II (Acute Physiology and Chronic Health Evaluation) score.
Improvement in APACHE II (Acute Physiology and Chronic Health Evaluation) score.
Effect on systemic haemodynamics in both groups.
Effect is defined as resolution of SIRS (Systemic Inflammatory Response Syndrome).
Effect on systemic haemodynamics in both groups.
Effect is defined as resolution of SIRS (Systemic Inflammatory Response Syndrome).
Pro inflammatory cytokines profile in both groups.
Serum Endotoxin levels in both groups.

Full Information

First Posted
February 29, 2016
Last Updated
November 18, 2019
Sponsor
Institute of Liver and Biliary Sciences, India
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1. Study Identification

Unique Protocol Identification Number
NCT02718079
Brief Title
High-Volume Plasma Exchange Versus Standard Medical Treatment in Patients With Acute Liver Failure
Official Title
High-Volume Plasma Exchange Versus Standard Medical Treatment in Patients With Acute Liver Failure-A Prospective Randomized Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
December 30, 2016 (Actual)
Primary Completion Date
October 8, 2018 (Actual)
Study Completion Date
October 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Liver Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard medical therapy with Plasma Exchange
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard medical therapy alone
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Plasma Exchange
Intervention Type
Other
Intervention Name(s)
Management of cerebral edema/intracranial hypertension:
Intervention Type
Other
Intervention Name(s)
Transfer to Intensive Care Unit
Intervention Type
Drug
Intervention Name(s)
Prophylactic Antibiotics
Intervention Type
Other
Intervention Name(s)
Intubation of trachea
Intervention Type
Other
Intervention Name(s)
Administration of mannitol or 3% saline for severe elevation of Intra Cranial Pressure
Intervention Type
Other
Intervention Name(s)
Volume Replacement
Intervention Type
Other
Intervention Name(s)
Pressor Support
Intervention Type
Drug
Intervention Name(s)
N-acetyl-L-cysteine
Intervention Type
Other
Intervention Name(s)
Correction of metabolic parameters
Intervention Type
Dietary Supplement
Intervention Name(s)
Correction of nutrition
Primary Outcome Measure Information:
Title
Survival in both groups.
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Duration of Intensive Care Unit stay in both groups.
Time Frame
21 days
Title
Improvement in SIRS (Systemic Inflammatory Response Syndrome) score.
Time Frame
48 hours
Title
Improvement in SIRS (Systemic Inflammatory Response Syndrome) score.
Time Frame
day 5
Title
Improvement in SIRS (Systemic Inflammatory Response Syndrome) score.
Time Frame
day 7
Title
Improvement in SOFA (Sequential Organ Failure Assessment) score.
Time Frame
48 hours
Title
Improvement in SOFA (Sequential Organ Failure Assessment) score.
Time Frame
day 5
Title
Improvement in SOFA (Sequential Organ Failure Assessment) score.
Time Frame
day 7
Title
Improvement in APACHE II (Acute Physiology and Chronic Health Evaluation) score.
Time Frame
48 hours
Title
Improvement in APACHE II (Acute Physiology and Chronic Health Evaluation) score.
Time Frame
Day 5
Title
Improvement in APACHE II (Acute Physiology and Chronic Health Evaluation) score.
Time Frame
Day 7
Title
Effect on systemic haemodynamics in both groups.
Description
Effect is defined as resolution of SIRS (Systemic Inflammatory Response Syndrome).
Time Frame
24 hours
Title
Effect on systemic haemodynamics in both groups.
Description
Effect is defined as resolution of SIRS (Systemic Inflammatory Response Syndrome).
Time Frame
48 hours
Title
Pro inflammatory cytokines profile in both groups.
Time Frame
1 hour
Title
Serum Endotoxin levels in both groups.
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Rakhi Maiwall, DM
Organizational Affiliation
Institute of Liver and Biliary Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of liver and Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33524593
Citation
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.
Results Reference
derived

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

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