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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02719210
Recruitment Status : Completed
First Posted : March 25, 2016
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
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.

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : January 1, 2016
Actual Primary Completion Date : November 30, 2018
Actual Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Mannitol

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

  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



Primary Outcome Measures :
  1. Transplant free Survival. [ Time Frame: 7 days ]
  2. Transplant free survival [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Survival after liver transplant with or without High Volume Plasma Exchange. [ Time Frame: 30 days post procedure ]
  2. Incidence of organ dysfunction (other than liver and Central Nervous System). [ Time Frame: 30 days ]
  3. Number of organs (other than liver and CNS) affected in children with organ dysfunction. [ Time Frame: 30 days ]
  4. Incidence of High Volume Plasma Exchange related complications- Major/Minor. [ Time Frame: within 1 month ]
  5. Change in hemodynamic parameters and Hepatic Encephalopathy (HE) before and after in the High Volume Plasma Exchange group. [ Time Frame: 0 day ]
  6. Change in hemodynamic parameters and Hepatic Encephalopathy (HE) before and after in the High Volume Plasma Exchange group. [ Time Frame: 5 days ]
  7. Change in Laboratory parameters - Bilirubin, INR and Ammonia in control group. [ Time Frame: 0 day ]
  8. Change in Laboratory parameters - Bilirubin, INR and Ammonia- in control group. [ Time Frame: 5 day ]
  9. 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 ]
  10. 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 ]


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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02719210


Locations
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India
Institute of liver and Biliary Sciences
New Delhi, Delhi, India, 110070
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
Investigators
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Principal Investigator: Dr Arti Pawaria, MD Institute of Liver and Biliary Sciences
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Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT02719210    
Other Study ID Numbers: ILBS-ALF-02
First Posted: March 25, 2016    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Liver Failure
Hepatic Insufficiency
End Stage Liver Disease
Acute-On-Chronic Liver Failure
Liver Failure, Acute
Liver Diseases
Digestive System Diseases
Mannitol
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs