An interventional study of High Volume Plasma Exchange and Hypertonic 3% saline in Acute Liver Failure, sponsored by Institute of Liver and Biliary Sciences, India. Completed at 1 site in India. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2018-12-06.
Sponsored by Institute of Liver and Biliary Sciences, India · Not applicable, Interventional, and Treatment
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.
445 studies on the registry are indexed under Liver Failure; 69 are open to participants now.
This study's enrollment of 75 is above the median of 43 across 276 interventional studies indexed under Liver Failure.
Browse Liver Failure studies →Institute of Liver and Biliary Sciences, India is the lead sponsor of 296 studies on the registry; 84 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Biological: High Volume Plasma Exchange
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
Drug: Hypertonic 3% saline · Drug: Mannitol · Device: Elective positive pressure ventilation
Transplant free Survival.
Time frame: 7 days
Transplant free survival
Time frame: 30 days
Survival after liver transplant with or without High Volume Plasma Exchange.
Time frame: 30 days post procedure
Incidence of organ dysfunction (other than liver and Central Nervous System).
Time frame: 30 days
Number of organs (other than liver and CNS) affected in children with organ dysfunction.
Time frame: 30 days
Incidence of High Volume Plasma Exchange related complications- Major/Minor.
Time frame: within 1 month
Change in hemodynamic parameters and Hepatic Encephalopathy (HE) before and after in the High Volume Plasma Exchange group.
Time frame: 0 day
Change in hemodynamic parameters and Hepatic Encephalopathy (HE) before and after in the High Volume Plasma Exchange group.
Time frame: 5 days
Change in Laboratory parameters - Bilirubin, INR and Ammonia in control group.
Time frame: 0 day
Change in Laboratory parameters - Bilirubin, INR and Ammonia- in control group.
Time frame: 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.
Time frame: 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.
Time frame: 5 days
Plan to share: Undecided
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This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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Institute of Liver and Biliary Sciences, India