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

Not Applicable

Completed

• Conditions: Acute Liver Failure
• Interventions: Biological: High Volume Plasma Exchange; Drug: Hypertonic 3% saline; Drug: Mannitol; Device: Elective positive pressure ventilation

• Registration Number: NCT02719210
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Study First Submitted: 2016-02-17
• Study First Submitted QC: 2016-03-21
• Study First Posted: 2016-03-25
• Status Verified: 2018-05
• Primary Completion: 2018-11-30
• Study Completion: 2018-11-30
• Last Update Submitted: 2018-12-04
• Last Update Posted: 2018-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Volume Plasma Exchange with Standard Treatment	High Volume Plasma Exchange	-
Standard Treatment	Hypertonic 3% saline	Standard Treatment is defined as anti raised Intra-cranial pressure 1. Elective positive pressure ventilation in hepatic encephalopathy grade 3 or 4 and in those with features of raised ICP (Intra-cranial pressure). 2. Mannitol 3. Hypertonic 3% Saline
Standard Treatment	Mannitol	Standard Treatment is defined as anti raised Intra-cranial pressure 1. Elective positive pressure ventilation in hepatic encephalopathy grade 3 or 4 and in those with features of raised ICP (Intra-cranial pressure). 2. Mannitol 3. Hypertonic 3% Saline
Standard Treatment	Elective positive pressure ventilation	Standard Treatment is defined as anti raised Intra-cranial pressure 1. Elective positive pressure ventilation in hepatic encephalopathy grade 3 or 4 and in those with features of raised ICP (Intra-cranial pressure). 2. Mannitol 3. Hypertonic 3% Saline

Primary Outcome Measures

Name	Time	Method
Transplant free Survival.	7 days
Transplant free survival	30 days

Secondary Outcome Measures

Name	Time	Method
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.	5 days
Survival after liver transplant with or without High Volume Plasma Exchange.	30 days post procedure
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

Trial Locations

Locations (1)

Institute of liver and Biliary Sciences; 🇮🇳 New Delhi, Delhi, India