Inflammation and Organ Impact During Hepatic Surgery

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.

Study Overview

• Status: Completed
• Conditions: Hepatic Surgery
• Intervention / Treatment: Procedure: elective surgery, according to deprtement routine

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• Sweden
  • Västra Götaland
    • Gothenburg, Västra Götaland, Sweden, 41345
      • SahlgrenskaUH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients scheduled for open liver resection, ASA class I-III.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Elective Hepatic Surgery; Patientes undergoing elective hepatic resection, managed according to departement routine.	Procedure: elective surgery, according to deprtement routine; none, descriptive study

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood loss	need of transfusion	from day of surgery and approximately 1 week onwards

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital
• Investigators: Principal Investigator: Sven-Erik Ricksten, MD, PhD, professor, Sahlgrenska University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2018
• Primary Completion (Actual): April 2, 2019
• Study Completion (Actual): April 2, 2019

Study Registration Dates

• First Submitted: November 6, 2018
• First Submitted That Met QC Criteria: March 14, 2019
• First Posted (Actual): March 18, 2019

Study Record Updates

• Last Update Posted (Actual): April 27, 2025
• Last Update Submitted That Met QC Criteria: April 23, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: blood loss; hepatic resection; inflammation; organ dysfunction; liver surgery; IFABP
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: Dnr740-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No