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Completed

NCT Number: NCT02718079

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

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.

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Key information

Conditions

Acute Liver Failure Digestive System Diseases Hepatic Insufficiency Liver Diseases Liver Failure Liver Failure, Acute

Age range

12 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of liver and Biliary Sciences

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Plasma Exchange

Biological

Management of cerebral edema/intracranial hypertension:

Other

Transfer to Intensive Care Unit

Other

Prophylactic Antibiotics

Drug

Intubation of trachea

Other

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

Other

Volume Replacement

Other

Pressor Support

Other

N-acetyl-L-cysteine

Drug

Correction of metabolic parameters

Other

Correction of nutrition

Dietary Supplement

Primary outcomes

  1. Survival in both groups.

    Time frame: 21 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Official study title

High-Volume Plasma Exchange Versus Standard Medical Treatment in Patients With Acute Liver Failure-A Prospective Randomized Pilot Trial

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 24, 2016
Registry last updated
Nov 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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