Inflammation and Organ Impact During Hepatic Surgery

Completed

• Conditions: Hepatic Surgery
• Interventions: Procedure: elective surgery, according to deprtement routine

• Registration Number: NCT03878615
• Lead Sponsor: Sahlgrenska University Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-11-06
• Study Start: 2018-11-10
• Study First Submitted QC: 2019-03-14
• Study First Posted: 2019-03-18
• Primary Completion: 2019-04-02
• Study Completion: 2019-04-02
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Elective Hepatic Surgery	elective surgery, according to deprtement routine	Patientes undergoing elective hepatic resection, managed according to departement routine.

Primary Outcome Measures

Name	Time	Method
Ischemic Intestinal Damage	from day of surgery until 24-48 hours postoperatively	rise in IFABP in nanograms/ml,
Kidney injury	from day of surgery until 24-48 hours postoperatively	NAG units/g increase in urine.
Intestinal Bacterial Transloction	from day of surgery until 24-48 hours postoperatively	Rise in D-lactate in micromol/ml

Secondary Outcome Measures

Name	Time	Method
Description of Inflammatory Response	from day of surgery and approximately 1 week onwards	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

Trial Locations

Locations (1)

SahlgrenskaUH; 🇸🇪 Gothenburg, Västra Götaland, Sweden