High Volume Plasma Exchange in Children With Acute Liver Failure and Acute on Chronic Liver Failure

Acute Liver Failure Clinical Trial

Official title:

High Volume Plasma Exchange in Children With Acute Liver Failure and Acute on Chronic Liver Failure-A Prospective Pilot Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02719210
• Other study ID #: ILBS-ALF-02
• Status: Completed
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: November 30, 2018

Study information

• Verified date: May 2018
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

All the children with acute liver failure who are candidates for transplant but have constraints for transplant will be randomized either to receive standard medical therapy or high volume plasma exchange along with standard medical therapy with the aim to assess the effect of high volume plasma exchange on transplant free survival.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

Inclusion Criteria:

• Children = 10kg with ALF with INR = 4 or INR = 3 with Hepatic Encephalopathy.

Exclusion Criteria:

1. Evidence of active infection (Age specific neutrophilic leucocytosis (ANC) and procalcitonin = 2 and/or focus of active infection

2. Refusal of consent or assent (annexure 3)

3. Liver resections with liver failure

4. Patients with clinical suspicion of irreversible brain injury

5. Patients with acute kidney injury

Related Conditions & MeSH terms

• Acute Liver Failure
• Acute-On-Chronic Liver Failure
• End Stage Liver Disease
• Liver Failure
• Liver Failure, Acute

Intervention

Biological:
• High Volume Plasma Exchange

Drug:
• Hypertonic 3% saline

• Mannitol

Device:
• Elective positive pressure ventilation

Locations

Country	Name	City	State
India	Institute of liver and Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transplant free Survival.		7 days
Primary	Transplant free survival		30 days
Secondary	Survival after liver transplant with or without High Volume Plasma Exchange.		30 days post procedure
Secondary	Incidence of organ dysfunction (other than liver and Central Nervous System).		30 days
Secondary	Number of organs (other than liver and CNS) affected in children with organ dysfunction.		30 days
Secondary	Incidence of High Volume Plasma Exchange related complications- Major/Minor.		within 1 month
Secondary	Change in hemodynamic parameters and Hepatic Encephalopathy (HE) before and after in the High Volume Plasma Exchange group.		0 day
Secondary	Change in hemodynamic parameters and Hepatic Encephalopathy (HE) before and after in the High Volume Plasma Exchange group.		5 days
Secondary	Change in Laboratory parameters - Bilirubin, INR and Ammonia in control group.		0 day
Secondary	Change in Laboratory parameters - Bilirubin, INR and Ammonia- in control group.		5 day
Secondary	Change in the levels of IL-6 and TNF alpha (Tumor Necrosis Factor) in HVPE arm from baseline till within 24-hours of the last session of High Volume Plasma Exchange.		within 24-hours of the last session of High Volume Plasma Exchange
Secondary	Change in the levels of IL-6 and TNF alpha (Tumor Necrosis Factor) in control arm from baseline till 5 days.		5 days