Hepatorenal Syndrome, Liver RegenerationNCT01700231
Plasma and Hemodynamic Markers During Hepatectomy
An observational study of Hepatorenal Syndrome, Liver Regeneration, run by Medical University of Vienna at 1 site in Austria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hepatorenal Syndrome, Liver Regeneration
- What is being tested?
- Liver resection
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2010to Aug 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with neoplastic liver tumors undergoing hepatectomy.
Who may be able to join
- Patient with neoplastic liver tumors undergoing elective hepatectomy.
Who cannot join
- Non elective hepatic surgery, preoperative HVPG > 10 mmHG, preoperative renal failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monitoring Plasma and Hemodynamic Markers in Patients Undergoing Liver Resection to Identify Pathophysiological Mechanisms and Predict Clinical Outcome
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).
Read more
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.
- Conditions
- Hepatorenal Syndrome, Liver Regeneration
- Being tested
- Liver resection
- Keywords
- hepatorenal syndrome, liver regeneration, liver dysfunction
- Medical subject headings
- Hepatorenal Syndrome, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver resectionProcedure or surgery
Liver resection of patient with neoplastic hepatic tumors
| Study group | Role | What they receive |
|---|---|---|
| Liver resection ,Liver Dysfunction | 100 patients will be monitored perioperatively, in a subset of 40 patients hepatic venous pressure gradient will be monitored Receives: Procedure: Liver resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startOct 2010
- Primary completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hepatorenal Syndrome, Liver RegenerationStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edith Fleischmann, Medical University of Vienna
- Investigators
- Edith Fleischmann, M.D., Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01700231
- Sponsor's protocol ID
- HVPG/Liver Regeneration Study
- Status last verified
- Apr 2015
- First submitted
- 2 Oct 2012
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Starlinger P, Pereyra D, Haegele S, Braeuer P, Oehlberger L, Primavesi F, Kohler A, Offensperger F, Reiberger T, Ferlitsch A, Messner B, Beldi G, Staettner S, Brostjan C, Gruenberger T. Perioperative von Willebrand factor dynamics are associated with liver regeneration and predict outcome after liver resection. Hepatology. 2018 Apr;67(4):1516-1530. doi: 10.1002/hep.29651. Epub 2018 Feb 27.
PubMed 29140542Padickakudy R, Pereyra D, Offensperger F, Jonas P, Oehlberger L, Schwarz C, Haegele S, Assinger A, Brostjan C, Gruenberger T, Starlinger P. Bivalent role of intra-platelet serotonin in liver regeneration and tumor recurrence in humans. J Hepatol. 2017 Dec;67(6):1243-1252. doi: 10.1016/j.jhep.2017.08.009. Epub 2017 Aug 24.
PubMed 28842294Pereyra D, Offensperger F, Klinglmueller F, Haegele S, Oehlberger L, Gruenberger T, Brostjan C, Starlinger P. Early prediction of postoperative liver dysfunction and clinical outcome using antithrombin III-activity. PLoS One. 2017 Apr 13;12(4):e0175359. doi: 10.1371/journal.pone.0175359. eCollection 2017.
PubMed 28406940Starlinger P, Assinger A, Haegele S, Wanek D, Zikeli S, Schauer D, Birner P, Fleischmann E, Gruenberger B, Brostjan C, Gruenberger T. Evidence for serotonin as a relevant inducer of liver regeneration after liver resection in humans. Hepatology. 2014 Jul;60(1):257-66. doi: 10.1002/hep.26950.
PubMed 24277679
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Plasma and Hemodynamic Markers in Patients Undergoing Liver Resection to Identify Pathophysiological Mechanisms and Predict Clinical Outcome
- ClinicalTrials.gov ID
- NCT01700231
- Acronym / sponsor ID
- HVPG/Liver Regeneration Study
- Conditions
- Hepatorenal Syndrome, Liver Regeneration
- Keywords
- hepatorenal syndrome, liver regeneration, liver dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Aug 2013 (actual)
- First posted
- 4 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver resection ,Liver Dysfunction | – | Procedure: Liver resection100 patients will be monitored perioperatively, in a subset of 40 patients hepatic venous pressure gradient will be monitored |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with neoplastic liver tumors undergoing hepatectomy.
Key inclusion criteria (1 listed)
- Patient with neoplastic liver tumors undergoing elective hepatectomy.
Key exclusion criteria (1 listed)
- Non elective hepatic surgery, preoperative HVPG > 10 mmHG, preoperative renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver resectionLiver resection of patient with neoplastic hepatic tumors | Procedure or surgery | Liver resection ,Liver Dysfunction |
Primary outcome
Perioperative blood parameters and HVPG
Time frame: 90 postoperative days
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
- Derived from this study: PubMed 29140542Starlinger P, Pereyra D, Haegele S, Braeuer P, Oehlberger L, Primavesi F, Kohler A, Offensperger F, Reiberger T, Ferlitsch A, Messner B, Beldi G, Staettner S, Brostjan C, Gruenberger T. Perioperative von Willebrand factor dynamics are associated with liver regeneration and predict outcome after liver resection. Hepatology. 2018 Apr;67(4):1516-1530. doi: 10.1002/hep.29651. Epub 2018 Feb 27.
- Derived from this study: PubMed 28842294Padickakudy R, Pereyra D, Offensperger F, Jonas P, Oehlberger L, Schwarz C, Haegele S, Assinger A, Brostjan C, Gruenberger T, Starlinger P. Bivalent role of intra-platelet serotonin in liver regeneration and tumor recurrence in humans. J Hepatol. 2017 Dec;67(6):1243-1252. doi: 10.1016/j.jhep.2017.08.009. Epub 2017 Aug 24.
- Derived from this study: PubMed 28406940Pereyra D, Offensperger F, Klinglmueller F, Haegele S, Oehlberger L, Gruenberger T, Brostjan C, Starlinger P. Early prediction of postoperative liver dysfunction and clinical outcome using antithrombin III-activity. PLoS One. 2017 Apr 13;12(4):e0175359. doi: 10.1371/journal.pone.0175359. eCollection 2017.
- Derived from this study: PubMed 24277679Starlinger P, Assinger A, Haegele S, Wanek D, Zikeli S, Schauer D, Birner P, Fleischmann E, Gruenberger B, Brostjan C, Gruenberger T. Evidence for serotonin as a relevant inducer of liver regeneration after liver resection in humans. Hepatology. 2014 Jul;60(1):257-66. doi: 10.1002/hep.26950.
Related trials for Hepatorenal Syndrome, Liver Regeneration
Not yet recruiting
Renal Histopathology and Transcriptomic Analysis in Hepatorenal Syndrome During Liver Transplantation
Hepatorenal Syndrome, Liver Regeneration, AKI - Acute Kidney Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edith Fleischmann, M.D. principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatorenal Syndrome, Liver Regeneration, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative blood parameters and HVPG (time frame: 90 postoperative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01700231, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015; AzTrials last refreshed its copy on 29 Oct 2026.