Hepatorenal Syndrome, Liver Regeneration Clinical Trial
Official title:
Monitoring Plasma and Hemodynamic Markers in Patients Undergoing Liver Resection to Identify Pathophysiological Mechanisms and Predict Clinical Outcome
| Verified date | April 2015 |
| Source | Medical University of Vienna |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Austria: Medical University of Vienna |
| Study type | Observational |
Introduction Liver resection is considered the only curative treatment option for mCRC
patients without extrahepatic disease and is accepted practice. Despite substantial
improvements in surgical techniques, postoperative morbidity and mortality remain an
important concern after major resections. Complications of liver resection, although rare,
include liver failure and acute kidney injury as indicated by oliguria and increased serum
creatinine. The underlying pathophysiological pathways of post-operative renal alteration
following liver resection is an increase in portal venous pressure, based on observations in
animal models or small cohorts. The corpus of data is derived from patients with liver
cirrhosis and subsequent hepatorenal syndrome. These data are limited since cirrhosis cannot
distinguish between metabolic changes, portal hypertension and impaired liver function in
the elucidation of the pathogenesis of renal alterations. Liver resection is therefore a
potent model to evaluate the impact of portal hypertension on the kidney despite stable
liver function.
The most significant factor determining morbidity and mortality following hepatectomy is the
ability of the remnant liver to regenerate. In this context, several growth factors were
shown to regulate the highly orchestrated process of liver regeneration (LR).
Hypothesis The investigators will therefore test the hypothesis that liver resection leads
to a sustained increase of portalvenous pressure with a subsequent episode of oliguric renal
impairment, correlating with the quantity of resected liver.
Furthermore, the investigators will examine the relationship between postoperative liver
regeneration and circulating growth factor levels in patients undergoing hepatectomy. Based
on the preclinical data the investigators hypothesize that a circulating growth factor
levels will be associated with delayed liver regeneration, an increased incidence of
postoperative liver dysfunction and concomitant worse clinical outcome.
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | |
| Est. primary completion date | August 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 85 Years |
| Eligibility |
Inclusion Criteria: - Patient with neoplastic liver tumors undergoing elective hepatectomy. Exclusion Criteria: - Non elective hepatic surgery, preoperative HVPG > 10 mmHG, preoperative renal failure |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Austria | General Hospital Vienna | Vienna |
| Lead Sponsor | Collaborator |
|---|---|
| Medical University of Vienna |
Austria,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Perioperative blood parameters and HVPG | Time course and predictive potential of blood parameter and HVPG in patients undergoing liver resection. Clinical outcome parameters are postoperative morbidity, mortality and liver dysfunction | 90 postoperative days | No |