Clinical trial of a blood purification system, HAYATE, on conciousness-recovery effect in patients with acute liver failure with hepatic coma

Not Applicable

• Conditions: acute liver failure with hepatic coma and late onset hepatic failure

• Registration Number: JPRN-UMIN000017938
• Lead Sponsor: Iwate Medical University

Brief Summary

Seven out of 8 (87.5%) patients regained consciousness during the on-line CHDF session, with 5 of those 7 waking within 4 days, while the others awoke on days 6 and 10. After waking, one patient spontaneously recovered, three received LT, two died of liver failure and one died of another disease. The plasma ammonia levels constantly and significantly decreased after the start of on-line CHDF from 182.5 +- 64.8 ug/dL (mean +- s.d.) at day 0 to 110.3 +- 48.0 ug/dL (p=0.0026) at day 3 and 87.0 +- 38.9 ug/dL at the last day of the session (p<0.001). Similarly, the plasma glutamine level also significantly decreased from 2069 +- 1234 umol/L at day 0 to 628 +- 193 umol/L at the last day. Although seven severe adverse events occurred during the ALS, including pneumonia, sepsis, disseminated intravascular coagulation, syncope, brain edema, ARDS and enteritis, no causal relationship to the ALS was recognized because of other apparent causes. Conclusions: Our newly-developed on-line CHDF ALS system showed extremely high efficacy for helping patients regain consciousness and excellent safety as therapy for ALF.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-17
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

(1) Child or elderly person who is intolerable to extracorporeal circulation (2) Patient with overt brain edema (3) Patient with liver malignancy (4) Hyperacute-type liver failure (5) Patient whose conscious level can't be evaluated (6) Patient who is intolerable to extracorporeal circulation because of unstable hemodynamics (7) Inadequate condition as considered by primary physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Consciousness-recovery rate within 10 days

Secondary Outcome Measures

Name	Time	Method
Change in serum ammonia level Change in blood glutamine level Change in serum TNF-alpha, IL-6, and IL-1beta levels Period to consciousness recovery Bridge to liver transplantation