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Inflammation and Organ Impact During Hepatic Surgery

Inflammation and Organ Impact During Hepatic Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03878615
Enrollment
18
Registered
2019-03-18
Start date
2018-11-10
Completion date
2019-04-02
Last updated
2025-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Surgery

Keywords

liver surgery, hepatic resection, inflammation, organ dysfunction, blood loss, IFABP

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.

Interventions

PROCEDUREelective surgery, according to deprtement routine

none, descriptive study

Sponsors

Sahlgrenska University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Ischemic Intestinal Damagefrom day of surgery until 24-48 hours postoperativelyrise in IFABP in nanograms/ml,
Kidney injuryfrom day of surgery and approximately 1 week onwardsas described by KDIGO (Kidney Disease Improving Global Outcomes) criteria
Intestinal Bacterial Transloctionfrom day of surgery until 24-48 hours postoperativelyRise in D-lactate in micromol/ml

Secondary

MeasureTime frameDescription
Description of Inflammatory Responsefrom day of surgery and approximately 1 week onwardsChanges 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

Other

MeasureTime frameDescription
blood lossfrom day of surgery and approximately 1 week onwardsneed of transfusion

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026