Clinical Trial: Steroids in Fulminant Hepatic Failure in the Pediatric Age Group

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Safety and Efficacy of Steroids in the Management of Fulminant Hepatic Failure in the Pediatric Age Group

Brief Summary: Fulminant hepatic failure (FHF) in children is a potentially devastating disease. The mortality rate may reach 80-90% in the absence of liver transplantation. Liver injury is considered to be mainly immune mediated with augmentation of cytolytic pathways of infected hepatocytes. For that, it is suggested that corticosteroids modulate the activity of the disease by suppressing the immune system.

Detailed Summary:

Fulminant hepatic failure (FHF) in children is a potentially devastating disease. The mortality rate may reach 80-90% in the absence of liver transplantation. FHF is the clinical manifestation of liver cell death of a critical degree with insufficient hepatocellular regeneration and characterized by coagulopathy with or without hepatic encephalopathy.

Liver injury is considered to be mainly immune mediated with augmentation of cytolytic pathways of infected hepatocytes. For that, it was suggested that corticosteroids modulate the activity of the disease by suppressing the immune system.


Sponsor: National Liver Institute, Egypt

Current Primary Outcome: Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: participants will be followed for the duration of hospital stay and allover the follow up period after hospital discharge, an expected average of 2 months. ]

Clinical and laboratory monitoring of patients for occurrence of side effects such as anaphylaxis, angioedema, cardiac arrest, cardiac arrhythmias, circulatory collapse, congestive heart failure, fat embolism, pulmonary edema, thromboembolism, pancreatitis.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Improvement in survival (without transplant). [ Time Frame: within 30 days of disease onset ]
    To evaluate the efficacy of steroids in improving the patient survival without the need for liver transplant
  • Decrease of prothrombin time [ Time Frame: 72 hour of start of treatment ]
  • Improvement of encephalopathy by one grade or more. [ Time Frame: 72 hour of start of treatment ]
  • Reduction of consciousness recovery time (CRT) among survivors [ Time Frame: Within 30 days of disease onset ]
  • Prolongation of time to death among non-survivors. [ Time Frame: Within 30 days of disease onset ]


Original Secondary Outcome:

  • Improvement in survival (without transplant). [ Time Frame: within 30 days of disease onset ]
    To evaluate the efficacy of steroids and/or GH in improving the patient survival without the need for liver transplant
  • Decrease of prothrombin time [ Time Frame: 72 hour of start of treatment ]
  • Improvement of encephalopathy by one grade or more. [ Time Frame: 72 hour of start of treatment ]
  • Reduction of consciousness recovery time (CRT) among survivors [ Time Frame: Within 30 days of disease onset ]
  • Prolongation of time to death among non-survivors. [ Time Frame: Within 30 days of disease onset ]


Information By: National Liver Institute, Egypt

Dates:
Date Received: February 14, 2015
Date Started: January 2015
Date Completion: September 2017
Last Updated: March 9, 2017
Last Verified: March 2017