Renal Histopathology and Transcriptomic Analysis in Hepatorenal Syndrome During Liver Transplantation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Hong Kong
About this trial
Hepatorenal Syndrome (HRS) is a serious complication that can occur in patients with liver cirrhosis, characterised by kidney dysfunction, or acute kidney failure (AKI). While it has traditionally been thought that HRS affects structurally normal kidneys and is completely reversible with liver transplantation, recent evidence suggests this may not always be the case.
The purpose of this study is to examine the actual structural changes in the kidneys of patients with HRS through tissue biopsy and advanced molecular analysis. This may help us better understand the disease mechanism and potentially improve treatment approaches. We aim to challenge the current understanding that HRS always occurs in structurally normal kidneys and is always reversible after liver transplantation. This study will provide valuable insights into the pathophysiology of HRS and may lead to improved diagnostic and treatment strategies in the future.
This is a 3-year single center prospective, non-randomised, open label study at Queen Mary Hospital, The University of Hong Kong. All consecutive patients accepted on the liver transplant waiting list will be invited to participate. Patient will undergo several procedures related to liver transplant and kidney assessment, and receive liver transplantation and renal biopsy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient must be able to understand and provide informed consent
Age ≥ 18 years of age at time of study entry
Accepted for liver transplantation (LT)
Fulfill the diagnostic criteria of HRS AKI according to International Club of Ascites (ICA) guidelines
Disqualifiers
Inability or unwillingness to give written informed consent
Patient with known pre-existing renal disease
Patient with solitary kidney
Re-transplantation
Trial design
Design model
Single group
Treatments tested in this trial
renal biopsy
Procedure/SurgeryTo examine the actual structural changes in kidneys of patients with HRS through tissue biopsy and advanced molecular analysis, and hope that may help us better understand the disease mechanism and potentially improve treatment approaches
Treatment groups
42 Participants
are divided into 1 treatment groupGroup A: Renal biopsyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of patients with HRS AKI
Proportion of patients with HRS AKI who have normal, reversible or permanent injury on renal histopathology
Time frame
up to 3 years2
Histopathological changes
Histopathological changes and their association with clinical parameters
Time frame
up to 3 yearsSecondary outcomes
1
Duration of HRS AKI
Incidence and duration of HRS AKI
Time frame
up to 3 years2
Response to standard treatment (Terlipressin and albumin)
Response to standard treatment (Terlipressin and albumin)
Time frame
up to 3 years3
Perioperative morbidity
Perioperative morbidity including need and duration for renal replacement therapy
Time frame
up to 3 years4
Post-transplant renal recovery rates
Post-transplant renal recovery rates
Time frame
up to 3 yearsSponsors and contacts
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Source ClinicalTrials.gov
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