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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
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

Tracking Information
First Submitted Date  ICMJE February 29, 2016
First Posted Date  ICMJE March 24, 2016
Last Update Posted Date November 20, 2019
Actual Study Start Date  ICMJE December 30, 2016
Actual Primary Completion Date October 8, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2016)
Survival in both groups. [ Time Frame: 21 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 22, 2016)
Survival in both groups [ Time Frame: 21 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 26, 2017)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2016)
  • To compare the improvement in serum ammonia. [ Time Frame: 1 year ]
    Improvement is defined as 10% reduction from baseline.
  • To compare the improvement in serum bilirubin. [ Time Frame: 1 year ]
    Improvement is defined as 10% reduction from baseline.
  • To compare the improvement in INR. [ Time Frame: 1 year ]
    Improvement is defined as 10% reduction from baseline.
  • To compare the improvement in bile acids. [ Time Frame: 1 year ]
    Improvement is defined as 10% reduction from baseline.
  • To compare the improvement in lactate. [ Time Frame: 1 year ]
    Improvement is defined as 10% reduction from baseline.
  • To compare the improvement in blood urea. [ Time Frame: 1 year ]
    Improvement is defined as 10% reduction from baseline.
  • To compare the improvement in serum creatinine. [ Time Frame: 1 year ]
    Improvement is defined as 10% reduction from baseline.
  • Adverse events of High Volume Plasma and Prometheus therapy in both groups [ Time Frame: 1 year ]
  • Duration of Mechanical ventilation in both groups. [ Time Frame: 1 year ]
  • Duration of Intensive Care Unit stay in both groups. [ Time Frame: 1 year ]
  • Improvement in SIRS (Systemic Inflammatory Response Syndrome) score. [ Time Frame: 1 year ]
  • Improvement in SOFA (Sequential Organ Failure Assessment) score. [ Time Frame: 1 year ]
  • Improvement in APACHE II (Acute Physiology and Chronic Health Evaluation) score. [ Time Frame: 1 year ]
  • Effect on systemic haemodynamics in both groups [ Time Frame: 1 year ]
    Effect is defined as resolution of SIRS ()
  • Cost of treatments in both groups [ Time Frame: 1 year ]
  • Pro inflammatory cytokines profile in both groups [ Time Frame: 1 year ]
  • Serum Endotoxin levels in both groups. [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE High-Volume Plasma Exchange Versus Standard Medical Treatment in Patients With Acute Liver Failure
Official Title  ICMJE High-Volume Plasma Exchange Versus Standard Medical Treatment in Patients With Acute Liver Failure-A Prospective Randomized Pilot Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Liver Failure
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • 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.
    Interventions:
    • 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
Publications * 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. 2021 Jan 29. pii: S1542-3565(21)00086-0. doi: 10.1016/j.cgh.2021.01.036. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 22, 2016)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 18, 2018
Actual Primary Completion Date October 8, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02718079
Other Study ID Numbers  ICMJE ILBS-ALF-03
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Institute of Liver and Biliary Sciences, India
Study Sponsor  ICMJE Institute of Liver and Biliary Sciences, India
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dr Rakhi Maiwall, DM Institute of Liver and Biliary Sciences
PRS Account Institute of Liver and Biliary Sciences, India
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP