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

NCT02718079 | Completed

• 1 other identifier: ILBS-ALF-03
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Liver Failure

Outcome Measures

Primary Outcomes (1)

• Survival in both groups.

  21 days

Secondary Outcomes (14)

• Duration of Intensive Care Unit stay in both groups.

  21 days

• Improvement in SIRS (Systemic Inflammatory Response Syndrome) score.

  48 hours

• Improvement in SIRS (Systemic Inflammatory Response Syndrome) score.

  day 5

• Improvement in SIRS (Systemic Inflammatory Response Syndrome) score.

  day 7

• Improvement in SOFA (Sequential Organ Failure Assessment) score.

  48 hours

Study Arms (2)

Standard medical therapy with Plasma Exchange

EXPERIMENTAL

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

Standard medical therapy alone

ACTIVE COMPARATOR

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

Interventions

Plasma Exchange BIOLOGICAL

Standard medical therapy with Plasma Exchange

Management of cerebral edema/intracranial hypertension: OTHER

Standard medical therapy alone; Standard medical therapy with Plasma Exchange

Transfer to Intensive Care Unit OTHER

Standard medical therapy alone; Standard medical therapy with Plasma Exchange

Prophylactic Antibiotics DRUG

Standard medical therapy alone; Standard medical therapy with Plasma Exchange

Intubation of trachea OTHER

Standard medical therapy alone; Standard medical therapy with Plasma Exchange

Administration of mannitol or 3% saline for severe elevation of Intra Cranial Pressure OTHER

Standard medical therapy alone; Standard medical therapy with Plasma Exchange

Volume Replacement OTHER

Standard medical therapy alone; Standard medical therapy with Plasma Exchange

Pressor Support OTHER

Standard medical therapy alone; Standard medical therapy with Plasma Exchange

N-acetyl-L-cysteine DRUG

Standard medical therapy alone; Standard medical therapy with Plasma Exchange

Correction of metabolic parameters OTHER

Standard medical therapy alone; Standard medical therapy with Plasma Exchange

Correction of nutrition DIETARY_SUPPLEMENT

Standard medical therapy alone; Standard medical therapy with Plasma Exchange

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

Related Publications (1)

• 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.

  PMID: 33524593 DERIVED

MeSH Terms

Conditions

Liver Failure, Acute

Interventions

Plasma Exchange; Intubation, Intratracheal; Sodium Chloride; Acetylcysteine

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Blood Transfusion; Biological Therapy; Therapeutics; Plasmapheresis; Blood Component Removal; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative; Airway Management; Intubation; Investigative Techniques; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Dr Rakhi Maiwall, DM

  Institute of Liver and Biliary Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2016
• First Posted: March 24, 2016
• Study Start: December 30, 2016
• Primary Completion: October 8, 2018
• Study Completion: October 18, 2018
• Last Updated: November 20, 2019

Record last verified: 2019-11

Locations

IN (1)