Inflammation and Organ Impact During Hepatic Surgery

Study Overview
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Brief Summary
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Monitoring of inflammatory substances (such as interleukins, CRP, albumine), and markers of organ dysfunction (such as creatinine, proenkephaline, amylase, troponine, IFABP and lactate) during elective liver resection. The study also includes monitoring of hemodynamic parameters, blood loss and postoperative complications. Results are to be used för power calculation for future trials.

Detailed Description
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During hepatic surgery, blood and urine samples will be obtained at 3 times during surgery, at 3 h after resection of liver, at 24 h after resection of liver and at post operative day 2, and subsequntly analyzed for the above mentioned substances. Routine labs will be monitored until patient is discharged from hospital. During surgery, hemodynamic parameters will be monitored by Picco calculations. Urine output and blood loss will be registred.

Official Title
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Inflammation and Organ Impact During Hepatic Surgery

Conditions
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Hepatic Surgery

Intervention / Treatment
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* Procedure: elective surgery, according to deprtement routine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I-III Patient has given informed consent to participate in study. Exclusion Criteria: preoperative kidney failure (E-GFR >30), current infection treatment with corticosteroids coagulopathy surgical or anatomical conditions that makes patient unsuitable for participation (for example reoperation, need of vascular bypass, single tumor)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Elective Hepatic Surgery<br>Patientes undergoing elective hepatic resection, managed according to departement routine. | Procedure: elective surgery, according to deprtement routine<br>* none, descriptive study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ischemic Intestinal Damage | rise in IFABP in nanograms/ml, | from day of surgery until 24-48 hours postoperatively | 
| Kidney injury | as described by KDIGO (Kidney Disease Improving Global Outcomes) criteria | from day of surgery and approximately 1 week onwards | 
| Intestinal Bacterial Transloction | Rise in D-lactate in micromol/ml | from day of surgery until 24-48 hours postoperatively | 
| Kidney injury | proenkephaline increase in pico mol/l | from day of surgery until 24-48 hours postoperatively | 
| Kidney injury | NAG units/g increase in urine. | from day of surgery until 24-48 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of Inflammatory Response | Changes in MCP-1, SDF-1, IL-1beta, TNF-alfa, IL-6, IL-8, IL-10 and HMBG-1, in blood samples obtained during and after heptaic surgery | from day of surgery and approximately 1 week onwards | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liver surgery, hepatic resection, inflammation, organ dysfunction, blood loss, IFABP