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

Sponsor

Institute of Liver and Biliary Sciences, India (Other)

Overall Status

Completed

CT.gov ID

NCT02719210

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Liver Failure	Biological: High Volume Plasma Exchange Drug: Hypertonic 3% saline Drug: Mannitol Device: Elective positive pressure ventilation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

75 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2016

Actual Primary Completion Date :

Nov 30, 2018

Actual Study Completion Date :

Nov 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High Volume Plasma Exchange with Standard Treatment	Biological: High Volume Plasma Exchange
Active Comparator: Standard Treatment Standard Treatment is defined as anti raised Intra-cranial pressure Elective positive pressure ventilation in hepatic encephalopathy grade 3 or 4 and in those with features of raised ICP (Intra-cranial pressure). Mannitol Hypertonic 3% Saline	Drug: Hypertonic 3% saline Drug: Mannitol Device: Elective positive pressure ventilation

Arm

Intervention/Treatment

Experimental: High Volume Plasma Exchange with Standard Treatment

Biological: High Volume Plasma Exchange

Active Comparator: Standard Treatment

Standard Treatment is defined as anti raised Intra-cranial pressure Elective positive pressure ventilation in hepatic encephalopathy grade 3 or 4 and in those with features of raised ICP (Intra-cranial pressure). Mannitol Hypertonic 3% Saline

Drug: Hypertonic 3% saline

Drug: Mannitol

Device: Elective positive pressure ventilation

Outcome Measures

Primary Outcome Measures

Transplant free Survival. [7 days]
Transplant free survival [30 days]

Secondary Outcome Measures

Survival after liver transplant with or without High Volume Plasma Exchange. [30 days post procedure]
Incidence of organ dysfunction (other than liver and Central Nervous System). [30 days]
Number of organs (other than liver and CNS) affected in children with organ dysfunction. [30 days]
Incidence of High Volume Plasma Exchange related complications- Major/Minor. [within 1 month]
Change in hemodynamic parameters and Hepatic Encephalopathy (HE) before and after in the High Volume Plasma Exchange group. [0 day]
Change in hemodynamic parameters and Hepatic Encephalopathy (HE) before and after in the High Volume Plasma Exchange group. [5 days]
Change in Laboratory parameters - Bilirubin, INR and Ammonia in control group. [0 day]
Change in Laboratory parameters - Bilirubin, INR and Ammonia- in control group. [5 day]
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]
Change in the levels of IL-6 and TNF alpha (Tumor Necrosis Factor) in control arm from baseline till 5 days. [5 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Evidence of active infection (Age specific neutrophilic leucocytosis (ANC) and procalcitonin ≥ 2 and/or focus of active infection
Refusal of consent or assent (annexure 3)
Liver resections with liver failure
Patients with clinical suspicion of irreversible brain injury
Patients with acute kidney injury